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Study of the Anti-Diabetic Market and

Doctor’s Perception Regarding the Drugs

Used in Diabetes Mellitus

Dissertation Submitted to the

Padmashree Dr. D.Y. Patil University In partial fulfillment of

the requirements for the award of the Degree

MASTERS IN BUSINESS ADMINISTRATION

Submitted by:

Swapnil Rathore

(Roll No.MB A-PH-012025)

Research Guide

Mr. Nimish Deshpande

Asst. Professor

Department of Business Management

Padmashree Dr. D.Y. Patil University

CBD Belapur, Navi Mumbai

March 2014

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DECLARATION

I, Swapnil Rathore hereby declare that the dissertation ―Study of the Anti-Diabetic

Market and Doctor’s Perception Regarding the Drugs Used In Diabetes Mellitus ‖

submitted for the MBA Degree at Padmashree Dr. D.Y. Patil University’s

Department of Business Management is my original work and the dissertation has

not formed the basis for the award of any degree, associate ship, fellowship or any

other similar titles.

Place: Mumbai

Date: Signature of the Student

SWAPNIL RATHORE

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CERTIFICATE

This is to certify that the dissertation entitled ―To study the anti- diabetic

market to study the doctors perception regarding the drugs used in diabetes.‖ is

the bonafide research work carried out by Mr.Swapnil Rathore student of

MBA, at Padmashree Dr. D.Y. Patil University Department of Business

Management during the year 20012-2014, in partial fulfillment of the

requirements for the award of the Degree of Master in Business Management

and that the dissertation has not formed the basis for the award previously of

any degree, diploma, associate ship, fellowship or any other similar title.

Dr. R. Gopal,

Director & HOD Mr. Nimish Deshpande

Department of Business Management, (Assistant Professor)

Padmashree Dr. D.Y. Patil University

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ACKNOWLEDGEMENT

In the first place, I thank Prof. Mr. Nimish Deshpande, Assistant Prof, Department of

Business Management, Padmashree Dr. D.Y.Patil University, Navi Mumbai for

having given me his valuable guidance for the project. Without his help it would have

been impossible for me to complete the project.

It is a matter of pleasure for me to work on a practical project like ―Study of the anti-

diabetic market and doctor‘s perception regarding the drugs used in diabetes‖ .This project

has added value to my theoretical knowledge. I would like to admit my sincere thanks to

the various people from Pharma industry & doctors who have provided me a lot of

information and data many of which I have used in this project and without which this

project could not have been completed.

I would be failing in my duty, if I do not acknowledge with a deep sense of gratitude the

sacrifices made by my parents, and those who helped me in completing project work

successfully.

Place: Mumbai

Date: Signature of Student

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PREFACE

Decision making is a fundamental part of the research process. Decisions regarding that

what you want to do, how you want to do, what tools and techniques must be used for the

successful completion of the project. The topics having aroused my curiosity,

discussions were held with several people in the Pharma sector to understand the

veracity of the above thought process and also understand the real issues of the industry.

Basically when we are playing with computer in every part of life, I used it in my project

not for the ease of my but for the ease of result explanation to those who will read this

project. The project presents the current market scenario of anti-diabetic market .

I had come across several difficulties to make the objectives a reality. I am presenting this

hand carved efforts in black and white. All these aspects then resulted in the

development of the project report titled ―Study of The Anti-Diabetic Market And

Doctor’s Perception Regarding The Drugs Used In Diabetes Mellitus.‖

It is strongly hoped that this project covers not only the various requirements of the

Project Study but also of the Industry.

Signature of the Student

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TABLE OF CONTENTS

TABLE OF CONTENTS

EXECUTIVE SUMMARY ................................................................................................. 7

RESEARCH METHODOLOGY......................................................................................... 9

DATA COLLECTION................................................................................................... 10

OBJECTIVE OF THE STUDY ......................................................................................... 13

INDUSTRY DEFINITIONS ............................................................................................. 15

DIABETES IN INDIA....................................................................................................... 16

The Risk Factors for Diabetes in Indians Are:............................................................... 16

Introduction of disease: .................................................................................................. 19

RESEARCH....................................................................................................................... 20

Objectives of research : .................................................................................................. 20

INTRODUCTION ............................................................................................................. 21

Types of Diabetes........................................................................................................... 24

DATA ANALYSIS & DATA INTERPRETATION ........................................................ 83

Data Analysis and Interpretation for Chemist Questionnaire ........................................ 93

CONCLUSION ................................................................................................................ 101

LIMITATION OF THE STUDY ..................................................................................... 102

SUGGESTION AND RECOMMENDATION................................................................ 103

APPENDIX ...................................................................................................................... 104

ANNEXURE-I ............................................................................................................. 104

ANNEXURE-II ............................................................................................................ 108

ANNEXURE-III........................................................................................................... 110

ANNEXURE-IV .......................................................................................................... 112

ANNEXURE-V............................................................................................................ 114

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EXECUTIVE SUMMARY

Diabetes is the syndrome of having excess blood sugar due to low levels of

insulin or insulin resistance. Approximately 21 million individuals in the U.S. have

diabetes, and this number is growing at 10% a year, or over 1.5 million new cases

annually. According to a new report published by Transparency Market Research .The

Global Market for Diabetes Management accounted for USD 40 billion in 2010 and is

expected to attain a market size of around USD 114 billion following a growth rate of

13.5% CAGR. The major products in this market consists of glucose meters, test strips,

lancets, continuous blood glucose meters, syringes, insulin pumps, insulin and other

insulin delivery devices and anti-diabetic drugs. However, insulin, test strips and anti-

diabetic drugs are the most revenue generating products.

Market Research is one of the most important function that a company or any

organization performs to identify its environment and adapt according to it .The title of

project is ¯ Study of the Anti-Diabetic Market and Doctor‘s Perception Regarding the

Drugs Used In Diabetes Mellitus. The objective of project is to find out the market of anti

spasmodic drugs, and also to find out what are trends of drugs mostly used by physicians.

The project is based on research of anti diabetes drug in market which are available in

market.

The project, the method adapted for primary data collection was survey (through

Questionnaire) method. This method was selected and used as it is extremely flexible and

more or less economic. Also some secondary data was collected through doctor‟s enquiry

and searching on the internet .During this project I had to face various problems regarding

the survey responses.

For the collection of primary data on Huminsulin (r) , I take a sample size 50 including

General physician & Diabetalogist .

The communication with doctor during survey concluded that the number of patients are

increasing day by day. one of senior doctor told that initially diabetes was very less as

compared to present. it can be said that the diabetes is increasing in double ratio specially

in old age people.

The survey from all doctor concluded that both type of diabetes patient i.e. non- insulin

dependent diabetes mellitus (NDDM) and insulin dependent diabetes mellitus (IDM)

approach to doctor.

Patients has to regularly monitor glucose level with glucometer like instruments. Diabetes

patient also need to take lot of care in diet and the medicine should be taken from time to

time. The IDDM patient need to take regularly subcutaneous injection of insulin. the

missing of drug dose and carelessness in diet can lead to threatening condition patient

may need to hospitalized.

The doctor also said that the fast food is also responsoible for increasing diabetes

patients. So they advice to take proper calorie food which is needed by patients.

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.While in case of NIDD doctors like to preffered drug as well as insulin injection. but the

diabetes can be controlled mostly by taking drug tolbutamide, chlorpropmide, metformin,

sitagliptin etc. regularly.

The most doctors said that the cost of treatment is affordable to patient is not sufficient

while few come to conclusion it may or may not be.

The near about 25% doctor said that there is not that much side effect which can be

neglected but there is only need to take proper dose should be given to patients according

to situation. some said there are side effect depend on patient physiology so few doctor

said that side effect can be or not.

The survey concluded that all doctors know about both brands metformin and huminsulin.

They said brands are most commonly prescribed. There is no hesitation in writing these

brands. Both brands have given excellent result. The patient to whom this brands are

prescribed they have given positive response.

No. of patients suffering from diabetes is constantly increasing; India is set to become the

global hub of diabetes in the coming decade. It is more prevalent amongst males.

Prediabetes is a stage between normal and diabetes stage. It is an alarming sign for

upcoming diabetes or a chance to change your future

Type 1 is treated with insulin replacement therapy — usually by injection or insulin

pump, along with attention to dietary management, typically including carbohydrate

tracking, and careful monitoring of blood glucose levels using Glucose meters.

Now a days Diabetes is a very common disorder in India as well as through out the wor ld.

Every fifth person is suffered by the diabetes disorder. India is an expanding stage in

Anti-diabetic market. In coming few years India is become the top position for diabetic

patient/Market.

The aged (old) people suffer more towards the diabetes disorder. There are lots of factors

responsible for diabetes.

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RESEARCH METHODOLOGY

Research refers to a search for knowledge. It is a systematic method of

collecting and recording the facts in the form of numerical data relevant to the formulated

problem and arriving at certain conclusions over the problem based on collected data.

Thus formulation of the problem is the first and foremost step in the research process

followed by the collection, tabulation and analysis and drawing the conclusions.

METHODS OF RESEARCH METHODOLOGY

SAMPLING METHOD:

The two major methods are probability and non-probability sampling technique. The

study requires probability method since the sample was chosen. Hence the study involve

choosing the doctors as sample study on the basis of the following factors such as number

of diabetes patients seen on the daily basis, percentage of prescribers of anti diab etes

drug, knowledge regarding diabetes and so on .

SURVEY METHOD

The most widely used technique of gathering primary data is the survey method. The

sources interviewed personally at the place of work and also with questionnaires. It is a

direct and more flexible form of investigation involving face- to- face communication and

through recorded questionnaires filled in personally.

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DATA COLLECTION

PRIMARY DATA COLLECTION:

It was collected from the physicians at their clinic by using the questionnaire method and

by survey of chemist.

SECONDARY DATA COLLECTION:

It was collected from the internet, books, journals, articles. Secondary data provides a

better view of the problem study.

Type of Research:

Quantitative Research

Sample size: 50 Physicians and Diabetalogist and 40 chemist.

Sample unit: Navi Mumbai area

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INTRODUCTION

Diabetes is a chronic disease that occurs when the pancreas does not

manufacture enough insulin, or alternatively, when the body cannot effectively use the

insulin it produces. Insulin is a hormone that controls the sugar level in the

bloodstream. If the sugar is not converted into energy for the body to use, it builds up.

In the long term, too much sugar, or glucose, in the body can lead to damage to the

heart, blood vessels, eyes, kidneys and nerves. The level of glucose in the blood can

also fluctuate throughout the day and needs to be closely monitored and controlled. As

a direct consequence of the continuing rise in diabetes, the market for diabetes

monitoring and controlling products continues to grow. Diabetes is often closely

associated with the weight condition and general health of an individual. A lack of

regular exercise and tendency toward obesity of the global population will likely drive

up incidence rates of diabetes. This trend is expected to continue as the World Health

Organization (WHO) projects an escalating prevalence worldwide as more cases are

identified. Progress in finding new treatments in care, new products (both therapeutic

and diagnostic), new developments in long-term treatments, and maturing public health

priorities will continue to create new shifts in the diabetes care industry. No. of patients

suffering from diabetes is constantly increasing; India is set to become the global hub

of diabetes in the coming decade. It is more prevalent amongst males. Calorie rich

diet, obesity and genetic factors are considered to be the main factors responsible

for diabetes. Precautions that doctors recommend would be important to note.

Due to the growing incidence and chronic nature of the disease, a drift

towards Ayurvedic and other alternate forms of medicine may be occurring. The

current shift, if any, may foretell trends. Diabetes gives rise to a host of other

complications. Knowing their incidence can give valuable inputs for co-

prescription, parallel prescription, product development/ improvement/ combinations

etc.

Dibetes has become very much a lifestyle disease in the metros with the

number of patients, especially in the younger age groups, sharply increasing. Thus,

knowing doctors‘ opinions (GPs and Specialists) on the same can give valuable

insights as to the current trends. Diabetes gives rise to a host of other complications.

Knowing their incidence can give valuable inputs for co-prescription, parallel

prescription, product development/ improvement/ combinations etc.

Diabetes has become very much a lifestyle disease in the metros with the

number of patients, especially in the younger age groups, sharply increasing. Thus,

knowing doctors‘ opinions (GPs and Specialists) on the same can give valuable

insights as to the current trends.

The main idea of the project is know how Anti-diabetic market going through

there in the basis of improved research and development. This project give the analysis

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of Indian Anti-diabetic market and also indicates that it is in booming stage Finally it

also the aim the Indian pharma industry is one of the competitive industry in the Indian

market as well as world market like China, US etc.

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OBJECTIVE OF THE STUDY

1) Analysis of prescription trends of Insulin.

2) Analysis of chemist sales of Insulin

Limitation of project:-

In recent year's diabetes drug market and insulin market has shown

remarkable growth. This growth is mostly driven by increasing prevalence o f

diabetes globally and easily availability of insulin in every country due to its access

at an affordable price. The diabetes prevalence is increasing due to changing food

habits in the western world leading to obesity.

As the prevalence of obesity and related diseases (diabetes) has increased,

so have the sales of drugs to treat them. Diabetic Division is a booming division in

Pharma industry so lot of competition in pharma industry it is part of difficulties to

collecting data .The limitation of the study is that small no. of sample siz

Market Structure:-

Diabetes affects at least 180 million people worldwide and is increasing, with the WHO

predicting 300 million diabetics by 2025. The United States alone has 20.8 million

people suffering from diabetes, equaling 6% of the population. Diabetes is currently

ranked sixth as a cause of death in the U.S.

There is no single remedy for diabetes. Likewise there is no cure. Most

treatments are multi-pronged – a focus on a healthy, controlled diet, regular exercise and

use of medications. As the disease progresses, regular daily injections of insulin may be

required. The diabetes care industry is divided into several categories. First is the

medication and pharmaceutical industry which covers the types of medication used

including insulin, insulin storage and its administration.

There is also a significant business in medications to prevent the progress of

the disease. These include Alternative Insulin Delivery Systems as well as a range of

Oral Anti Diabetics (OADs) on the other.

Secondly, the dietary supplement industry has also impacted the diabetes

products market. Various pro diabetic food items, such as diabetic ice creams, pastries,

etc. are available in the market. Finally, exercise, yoga and other alternative therapies

have also been embraced by the diabetes care industry. Significant emphasis has been

placed on the importance of a healthy exercise regimen for patients suffering from

diabetes.

As part of a diabetes care program, an individual with diabetes also

needs access to monitoring supplies such as test strips and blood glucose measuring

hand-held meters. This has boosted the production of various monitoring equipment

and other pathological infrastructure items assisting the diagnosis and sustained

treatment of diabetes.

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Diabetes treatment is expensive. According to the

American Diabetes Association, people who have this disease spend an average of

$13,243 a year on health care expenses. Hence the need for insurance plan that

covers as many diabetes-related expenses as possible. This has caused a further

challenge for the healthcare environment. An individual with diabetes can be

confronted with trouble in obtaining and keeping health insurance and life

insurance. Approximately 21 million American children and adults are victims of

diabetes, but a significant share of these are uninsured and cannot gain access to the

supplies, medications, and education necessary to effectively handle the disease.

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INDUSTRY DEFINITIONS

Hypoglycemia - a condition that occurs when blood glucose is lower than normal,

usually less than 70 mg/dL. Signs include hunger, nervousness, shakiness, perspiration,

dizziness or light- headedness, sleepiness, and confusion.

Hyperglycemia – a condition of excessive blood glucose. Fasting hyperglycemia is

blood glucose above a desirable level after a person has fasted for at least 8 hours.

Diabetes insipidus - A condition characterized by frequent and heavy urination,

excessive thirst and an overall feeling of weakness. This condition may be caused

by a defect in the pituitary gland or in the kidney. In diabetes insipidus, blood

glucose levels are normal.

Diabetes mellitus - A condition characterized by hyperglycemia resulting from the

body's inability to use blood glucose for energy.

Type 1 Diabetes - In Type 1 diabetes, the pancreas no longer makes insulin and

therefore blood glucose cannot enter the cells to be used for energy.

Type 2 Diabetes - In Type 2 diabetes, either the pancreas does not make enough

insulin or the body is unable to use insulin correctly

Fasting blood glucose - A method for learning how much glucose (sugar) there is in

a blood sample taken after an overnight fast. The fasting blood glucose test is

commonly used in the detection of diabetes mellitus. The normal, range for blood

glucose is from 70 to 110 mg/dl, depending on the type of blood being tested. If the

level is over 140 mg/dl, it usually means the. Person has diabetes (except for newborns

and some pregnant women).

Insulin - a hormone that regulates the amount of glucose (sugar) in the blood and is

required for the body to function normally. Cells in the pancreas, called the islets of

Langerhans, produce insulin.

Blood glucose monitoring - checking blood glucose level on a regular basis in order to

manage diabetes is called blood sugar monitoring. A blood glucose meter (or blood

glucose test strips that change color when touched by a blood sample) is needed for

frequent blood glucose monitoring.

Thiazolidinedione - a class of oral medications for Type 2 diabetes that helps insulin

take glucose from the blood into the cells for energy by making cells more sensitive to

insulin.

(Generic names: pioglitazone and rosiglitazone)

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DIABETES IN INDIA

Current Status:-

Diabetes has emerged as a major healthcare problem in India. According

to Diabetes Atlas published by the International Diabetes Federation (IDF), there were

an estimated 40 million persons with diabetes in India in 2007 and this number is

predicted to rise to almost 70 million people by 2025. The countries with the largest

number of diabetic people will be India, China and USA by 2030. It is estimated that

every fifth person with diabetes will be an Indian. Due to these sheer numbers, the

economic burden due to diabetes in India is amongst the highest in the world. The real

burden of the disease is however due to its associated complications which lead to

increased morbidity and mortality. WHO estimates that mortality from diabetes, heart

disease and stroke costs about $210 billion in India in the year 2005. Much of the heart

disease and stroke in these estimates was linked to diabetes. WHO estimates that

diabetes, heart disease and stroke together will cost about $ 333.6 billion over the next

10 years in India alone?

Rapid urbanization and industrialization have produced advancement on the

social and economic front in developing countries such as India which have resulted in

dramatic lifestyle changes leading to lifestyle related diseases. The transition from a

traditional to modern lifestyle, consumption of diets rich in fat and calories combined

with a high level of mental stress has compounded the problem further. There are

several studies from various parts of India which reveal a rising trend in the prevalence

of type II diabetes in the urban areas. A National Urban Survey in 2000 observed that

the prevalence of diabetes in urban India in adults was 12.1 per cent per cent. Recent

data has illustrated the impact of socio-economic transition occurring in rural India.

The transition has occurred in the last 15 years and the prevalence has risen from 2.4 per

cent to 6.4 per cent.

The Risk Factors for Diabetes in Indians Are:

Age—Indians develop diabetes at a very young age, at least 10 to 15 years earlier than

the western population. An early occurrence of diabetes gives ample time for

development of the chronic complications of diabetes. The incidence of diabetes

increases with age. In India, the life span has increased, hence more number of people

with diabetes are being detected.

Family History—The prevalence of diabetes increases with a family history of

diabetes. The risk of a child developing diabetes with a parental history increases above

50 per cent. A high incidence of diabetes is seen among the first degree relatives.

Indians have a high genetic risk for diabetes as observed in Asian Indians who have

migrated to other countries. They have been found to have a higher rate of diabetes as

compared to the local population .

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Central Obesity—The association of obesity with Type II Diabetes is well known. Even

with an acceptable body weight range, weight gain could increase the risk of diabetes.

An excess of body fat specially concentrated within the abdomen has an increased risk of

diabetes. The cut-off limit for waist circumference for Indians has been recommended to

be 90 cm for males and 80 cm for females. Abdominal obesity is defined by waist

circumference above these limits.

Physical Inactivity and Sedentary Living—There is enough evidence to demonstrate

that physical inactivity as a independent factor for the development of type II diabetes.

The availability of motorised transport and a shift in occupations combined with the

plethora of television programmes has reduced the physical activity in all groups of

populations.

Insulin Resistance— Asian Indians have been found to be more insulin resistant as

compared to the white population. They have a higher level of insulin to achieve

the same the blood glucose control. A cluster of factors consisting of abnormal fats

(Dyslipidemia), high blood pressure, obesity, and abnormal glucose levels known

as metabolic syndrome is highly prevalent in Asian Indians.

Urbanisation—The developing countries like India are undergoing rapid urbanisation .

Urbanisation is associated with increasing obesity, decreasing physical activity due to

changes in lifestyle, diet and a change from manual work to less physical occupations.

Stress—The impact of stress both physical and mental along with lifestyle changes has

a strong effect of increasing incidence of type II Diabetes amongst persons is a strong

genetic background. In a recent study in Chennai, nearly 25 per cent of the population

studied was unaware of a condition called diabetes. Only 40 per cent of the participants

felt that prevalence of diabetes was increasing and only 22 per cent of the population

felt that diabetes could be prevented. Though the awareness levels increased with

education, only 42.6 per cent of postgraduates and professionals including doctors knew

that diabetes was preventable. The knowledge of risk factors was even lower, only 11.9

per cent of the study subjects reported obesity and physical inactivity as risk factors.

Even amongst the known diabetics, only 40.6 per cent were aware that diabetes could

lead to some organ damage and complications. Many people (46 per cent) with diabetes

felt that it was a temporary phenomenon.

In a study in 1998, Diabcare Asia Study, it was observed that of all the patients with

diabetes taking treatment from specialized centers, more than 50 per cent of patients

had poor control of diabetes as per the criteria of American Diabetes Association. The

Study showed that four per cent of patients were on diet therapy alone, 53.9 per cent

were receiving oral antidiabetic agents, 22 per cent of the patients were taking insulin

and another 19 per cent were on both insulin and oral drugs. This Study confirmed that

diabetes care in India leaves much to be desired.

In two other studies carried out in Bangalore and South India, it was observed that

majority of patients (70 per cent) were diagnosed by their general practitioners (GP)

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and 70 per cent of them had approached the GP for some other problem. 90 per cent

of them underwent only Fasting and Post Meal Blood Sugar and Urine Sugar Tests.

Specialized tests such as Glycosylated Hemoglobin (HbA1C), lipid profile, kidney

Function test were undertaken by only four-six percent of patients. Even simple

measurement of blood pressure, weight and examination of feet were not done for

majority of patients.

In India, the lack of proper healthcare infrastructure, rampant ignorance

and absence of clear cut guidelines mean that approach to the management of

diabetes is ad hoc. The lack of awareness among patients and General Practitioners

(GPs) is a key factor in the poor care. There are practically no nurse educators or

diabetic counselors, no podiatrists (foot experts) and very few dieticians who mean

that the treating doctor has no support and has to take the entire burden of caring for

these patients. The patients' inability/unwillingness to pay for this additional support

also hinders the treatment.

Even after the diagnosis, monitoring of diabetes is very poor. Most of the

patients initially visit a doctor and then discontinue their therapy once their symptoms

and controlled. A majority of the patients abandon modern allopathic treatment in

favors of indigenous treatments. Further, more patients with poor control avoid insulin

for fear of injection and belief of addiction of insulin. Hence they keep changing

doctors and hop from one system of treatment to another leading to further

complications and early death. Lack of resources, medical reimbursement and poor

state funding for diabetes is a barrier to quality care often because the patient is unable

to afford the high cost of treatment.

There is ample evidence to suggest that preventive measures to reduce the burden of

diabetes are needed. The US Diabetes Prevention Programme and the Finnish Diabetes

Prevention Programme and the Chinese Study have conclusively proved that lifestyle

modification including weight loss, increased physical activity and dietary changes can

prevent or delay the onset of diabetes. The need of the hour is direct public education

and mass media campaigns, awareness about diabetes and its complications. There is a

need to spread the message that diabetes is preventable and we need to have a

behavioral change to adopt a healthy lifestyle.

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Introduction of disease:

History and Statistic

Diabetes is not a newly born disease, it has been with human race from

long back but, we came to knew about it in 1552 B.C. Since this period, many of

Greek as well French physicians had worked on it and made us aware of the nature of

disease, organs responsible for it etc. In 1870s, a French physician had discovered a

link between Diabetes and diet intake, and an idea to formulate individual diet plan

came into picture.

Diabetic diet was formulated with inclusion of milk, oats and other fiber

containing foods in 1900-1915. Function of insulin, its nature, along with its use started

from 1920 -1923, discovered by Dr. Banting, Prof. Macleod and Dr .Collip, who were

awarded a Noble prize. In the decade of 1940, it has been discovered that different

organs like kidney and skin are also affected if diabetes is creeping from a long term. A

major turn in this research was in the year 1955, when the oral hypogycemic drugs had

been manufactured. Diabetes was recognized with complete details and its types (Type

1and Type 2 diabetes - that is insulin dependent and non insulin dependent) in the year,

1959. As we know this is one of the old diseases, existing in many individuals and still

on rising charts. Hence, scientists are continuously working to relieve us from it, by

discovering the relevant drugs and making new researches.

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RESEARCH

Research in common parlance refers to a search for knowledge. Once can

also define research as a scientific and systematic search for pertinent information on a

specific topic. In fact, research is an art of scientific investigation. The Advanced

Learner‘s Dictionary of Current English lays down the meaning of research as ―a careful

investigation or inquiry specially through search for new facts in any branch of

knowledge.‖1 Redman and Mory define research as a ―systematized effort to gain new

knowledge.‖2 Some people consider research as a movement, a movement from the

known to the unknown. It is actually a voyage of discovery. We all possess the vital

instinct of inquisitiveness for, when the unknown confronts us, we wonder and our

inquisitiveness makes us probe and attain full and fuller understanding of the unknown.

This inquisitiveness is the mother of all knowledge and the method, which man employs

for obtaining the knowledge of whatever the unknown, can be termed as research.

Research is an academic activity and as such the term should be used in a technical sense.

According to Clifford Woody research comprises defining and redefining problems,

formulating hypothesis or suggested solutions; collecting, organising and evaluating data;

making deductions and reaching conclusions; and at last carefully testing the conclusions

to determine whether they fit the formulating hypothesis. D. Slesinger and M. Stephenson

in the Encyclopaedia of Social Sciences define research as ―the manipulation of things,

concepts or symbols for the purpose of generalising to extend, correct or verify

knowledge, whether that knowledge aids in construction of theory or in the practice of an

art.‖3 Research is, thus, an original contribution to the existing stock of knowledge

making for its advancement. It is the persuit of truth with the help of study, observation,

comparison and experiment. In short, the search for knowledge through objective and

systematic method of finding solution to a problem is research. The systematic approach

concerning generalisation and the formulation of a theory is also research. As such the

term ‗research‘ refers to the systematic method.

Objectives of research :

The purpose of research is to discover answers to questions through the

application of scientific procedures. The main aim of research is to find out the truth

which is hidden and which has not been discovered as yet. Though each research study

has its own specific purpose, we may think of research objectives as falling into a number

of following broad groupings:

1. To gain familiarity with a phenomenon or to achieve new insights into it (studies with

this object in view are termed as exploratory or formulative research studies)

2. To portray accurately the characteristics of a particular individual, situation or a group

(studies with this object in view are known as descriptive research studies)

3. To determine the frequency with which something occurs or with which it is associated

with something else (studies with this object in view are known as diagnostic research

studies);

4. To test a hypothesis of a causal relationship between variables (such studies are known

as hypothesis-testing research studies).

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INTRODUCTION

Sweet has no place in this life. Everyone and everything has turned bitter.

This is the pathetic condition of a diabetic patient. Once detected of diabetes, the world

becomes a bitter one. Hereditary and environmental reasons like lack of exercise and

obesity can be the real cause of this disease. Still the mystery that hovers above the

disease continues. Immense papers are published; the scientific fraternity is toiling day

and night to decipher the exact cause of the disease. The general condition of the body

that does not produce insulin or use it in a proper manner is called diabetes.

Diabetes is a metabolic disorder where in human body does not produce

or properly uses insulin, a hormone that is required to convert sugar, starches, and other

food into energy. Diabetes mellitus is characterized by constant high levels of blood

glucose (sugar). Human body has to maintain the blood glucose level at a very narrow

range, which is done with insulin and glucagon. The function of glucagons is causing

the liver to release glucose from its cells into the blood, for the production of energy

And what is this insulin? Insulin is the hormone that regulates glucose levels in the

blood The FPG (Fasting Plasma Glucose) test or OGTT (Oral Glucose Tolerance Test)

determines whether you are diabetic or not. The FPG test is the more economical,

fastest and easiest test. If the blood sugar level is between 100 and 125mg/dl on the

FPG test then it denotes pre- diabetes and if it is 126mg/dl or above the person suffers

from diabetes. . Desired blood sugar of human body should be between 70 mg/dl -110

mg/dl at fasting state.

If blood sugar is less than 70 mg/dl, it is termed as hypoglycemia and if more than 110

mg /dl, it‘s hyperglycemia Both lead to hyperglycemia where urine is produced

excessively, vision is blurred, lethargy, weight loss, and increased fluid intake. With

the discovery of insulin from 1921, diabetes has become treatable and manageable.

Type 1 diabetes is treated by administering insulin externally either by syringe or

insulin pump. Type 2 is treated by dietary supplements and insulin recommendations.

A hormone that is required to convert sugar, starches, and other food into

energy. Diabetes mellitus is characterized by constant high levels of blood glucose

(sugar).

Human body has to maintain the blood glucose level at a very narrow

range, which is done with insulin and glucagon. The function of glucagons is causing

the liver to release glucose from its cells into the blood, for the production of energy.

There are three main types of diabetes:

Type 1 diabetes

Type 2 diabetes

Gestational diabetes

Type 1 and Type 2 diabetes impede a person‘s carefree life. When breakdown of

22

glucose is stopped completely, body uses fat and protein for producing the energy.

Due to this mechanism symptoms like polydipsia, polyuria, polyphegia, and

excessive weightloss can be observed in a diabetic.

Diabetes is the primary reason for adult blindness, end-stage renal

disease (ESRD), gangrene and amputations. Overweight, lack of exercise, family

history and stress increase the likelihood of diabetes. When blood sugar level is

constantly high it leads to kidney failure, cardiovascular problems and neuropathy.

Patients with diabetes are 4 times more likely to have coronary heart disease and

stroke. In addition, Gestational diabetes is more dangerous for pregnant women and

their fetus. Though, Diabetes mellitus is not completely curable but, it is controllable

to a great extent.

So, you need to have thorough diabetes information to manage this it

successfully.

The control of diabetes mostly depends on the patient and it is his/her

responsibility to take care of their diet, exercise and medication. Advances in diabetes

research have led to better ways of controlling diabetes and treating its complications.

Hence they include:-

New improved Insulin and its therapy, (external and implantable insulin pumps)

have advanced well to manage elevated blood sugars without any allergic reactions.

Oral hypoglycemic drug,

controls diabetes type 2.

New improved blood glucose monitor (new device for self blood glucose monitoring),

and hemoglobin A1c laboratory test to measure blood glucose control during previous 3

months. Effective availability of the treatments for affected body organs due to

diabetes.Better ways to manage mother and its fetus health during the gestational

diabetes phase.

Prediabetes

Prediabetes is a stage between normal and diabetes stage. It is an

alarming sign for upcoming diabetes or a chance to change your future. Universally,

numerous terms are given like, Borderline Diabetes, Chemical Diabetes, Touch of

Diabetes etc. The term Prediabetic was given by the US Department of Health And

Human Services and ADA on 27th march 2002 with an intention to create awareness

and convey seriousness of the condition. Also, they motivated people to opt for

appropriate treatment and lifestyle modification.

According to the ADA statistics 17 million US citizens are diabetic and 16 millions are

prediabetic. ADA defines it as a stage before the development of diabetes, with normal

glucose tolerance, but with an increased risk of developing diabetes in near future.

23

Prediabetes is a condition when your blood sugar level triggers higher than normal, but

not so high that we can justify it as type 2 diabetes. According to the Centers for

Disease Control and Prevention,

41 million U.S. adults aged 40 to 74 have prediabetes. And the same reports from, The

American Academy of Pediatrics show that, one of every 10 males and one of every 25

females have prediabetes aged from 12 to 19 years.

Signs and Symptoms of Prediabetes

Prediabetes can take a long time to transform finally as diabetes. It has

been generally observed that prediabetes will eventually convert to diabetes but, at the

same time, there are greater possibilities to revert back to

normal if, taken care seriously. People suffering from prediabetes may show same

symptoms as in diabetes but, they will be erupting occasionally like:

Excessive thirst

Tingling sensations in feet and fingers

Excess-Hunger

Frequent-Urination

Irritability

Frequent infections

Blurred vision

Skin itching

People - In Risk Zone: Some individuals are at more risk of prediabetes than others due

to presence of these factors -

Being overweight

Family history of prediabetes

Waist hip ratio - The person with 'fat tire'

Depression and stress

Causes: Prediabetic is a person suffering from little high sugar than normal patients.

The reason behind high sugar is entry of glucose into the blood cells due to disturbance

in the mechanism of insulin. Thus, sugar is circulating in the blood stream but unable to

peetrate into cells and tissue, to produce energy. The exact reason for this is uncertain

but it is considered that overweight and fatty tissues along with sedentary lifestyle are

the correlating factors.

24

Types of Diabetes

1) Type 1 diabetes

Diabetes mellitus type 1 (type I diabetes, T1D, T1DM, IDDM, juvenile

diabetes) is a form of diabetes mellitus. Type 1 diabetes is an autoimmune disease that

results in destruction of insulin-producing beta cells of the pancreas. Thus far, such

destruction has been permanent, but there is informed speculation that reversing the

immune system malfunction may allow recovery of beta cell function. Lack of insulin

causes an increase of fasting blood glucose (around 70-120 mg/dL in nondiabetic

people) that begins to appear in the urine above the renal threshold (about 190-200mg/dl

in most people), thus connecting to the symptom by which the disease was identified in

antiquity, sweet urine. Glycosuria or glucose in the urine causes the patients to urinate

more frequently, and drink more than normal (polydipsia). Classically, these were the

characteristic symptoms which prompted discovery of the disease.

Type 1 is lethal unless treated with exogenous insulin. Injection is the

traditional and still most common method for administering insulin; jet injection,

indwelling catheters and inhaled insulin has also been available at various times, and

there are several experimental methods as well. All replace the missing hormone

formerly produced by the now non-functional beta cells in the pancreas.

In recent years, pancreas transplants have also been used to treat type 1

diabetes. Islet cell transplant is also being investigated and has been achieved in mice

and rats, and in experimental trials in humans as well. Use of stem cells to produce a

new population of functioning beta cells seems to be a future possibility, but has yet to

be demonstrated even in laboratories as of 2008.

Type 1 diabetes (formerly known as "childhood", "juvenile" or "insulin- dependent"

diabetes) is not exclusively a childhood problem; the adult incidence of type 1 is

noteworthy — many adults who contract type 1 diabetes are misdiagnosed with type 2

due to confusion on this point. There is currently no clinically useful preventive

measure against developing type 1 diabetes, though a vaccine has been proposed and

anti-antibody approaches are also being investigated. Most people who develop type 1

were otherwise healthy and of a healthy weight on onset, but they can lose weight

quickly and dangerously, if not promptly diagnosed. Although the cause of type 1

diabetes is still not fully understood, and diet and exercise may help, the immune

system damage is characteristic of type 1.

The most definite laboratory test to distinguish type 1 from type 2

diabetes is the C-peptide assay, which is a measure of endogenous insulin production

since external insulin has not (to date) included C-peptide. The presence of anti- islet

antibodies (to Glutamic Acid Decarboxylase, Insulinoma Associated Peptide-2 or

insulin), or lack of insulin resistance, determined by a glucose tolerance test, would also

be suggestive of type 1. Many type 2 diabetics continue to produce insulin internally,

25

and all have some degree of insulin resistance.

Pathophysiology

The cause of type 1 diabetes is still not fully understood. Some theorize

that type 1 diabetes is generally a virally triggered autoimmune response in which the

immune system's attack on virus infected cells is also directed against the beta cells in

the pancreas. The autoimmune attack may be triggered by reaction to an infection, for

example by one of the viruses of the Coxsackie virus family or German measles,

although the evidence is inconclusive. In type 1, pancreatic beta cells in the Islets o f

Langerhans are destroyed or damaged sufficiently to effectively abolish endogenous

insulin production. This etiology distinguishes type 1's origin from type 2. It should

also be noted that the use of insulin in treating a patient does not mean that

patient has type 1 diabetes; the type of diabetes a patient has is determined only by the

cause -- fundamentally by whether the patient is insulin resistant (type 2) or insulin

deficient without insulin resistance (type 1) Some researchers believe that the

autoimmune response is influenced by antibodies against cow's milk proteins. A large

retrospective controlled study published in 2006 strongly suggests that infants who

were never breastfed had a risk for developing type 1 diabetes twice that of infants

who were breastfed for at least three months. The mechanism is not fully understood.

No connection has been established between auto antibodies, antibodies to cow's milk

proteins, and type 1 diabetes. A subtype of type 1 (identifiable by the presence of

antibodies against beta cells) typically develops slowly and so is often confused with

type 2. In addition, a small proportion of type 1 cases have the hereditary condition

maturity onset diabetes of the young (MODY) which can also be confused with type 2.

Vitamin D in doses of 2000 IU per day given during the first year of a child's life has

been connected in one study in Northern Finland (where intrinsic production of

Vitamin D is low due to low natural light levels) with an 80% reduction in the risk of

getting type 1 diabetes later in life. The causal connection, if any, is obscure.

Some suggest that deficiency of Vitamin D3 (one of several related

chemicals with Vitamin D activity) may be an important pathogenic factor in type 1

diabetes independent of geographical latitude, and so of available sun intensity. Some

chemicals and drugs preferentially destroy pancreatic cells. Vacor (N- 3-pyridylmethyl-

N'-p-nitrophenyl urea), a rodenticide introduced in the United States in 1976, selectively

destroys pancreatic beta cells, resulting in type 1 diabetes after accidental or intentional

ingestion. Vacor was withdrawn from the U.S. market in 1979, but is still used in some

countries. Zanosar is the trade name for streptozotocin, an antibiotic and antineoplastic

agent used in chemotherapy for pancreatic cancer; it also kills beta cells, resulting in loss

of insulin production. Other pancreatic problems, including trauma, pancreatitis or

tumors (either malignant or benign), can also lead to loss of insulin production. The

exact cause(s) of type 1 diabetes are not yet fully understood, and research on those

mentioned, and others, continues. In December 2006, researchers from Toronto Hospital

26

for Sick Children published research that shows a link between type 1 diabetes and the

immune and nervous system.

Using mice, the researchers discovered that a control circuit exists between insulin-

producing cells and their associated sensory (pain-related) nerves. It's being suggested

that faulty nerves in the pancreas could be a cause of type 1 diabetes. control circuit

exists between insulin-producing cells and their associated sensory (pain-related) nerves.

It's being suggested that faulty nerves in the pancreas could be a cause of type 1 diabetes.

Inheritance

Type 1 Diabetes is a polygenic disease, meaning many different genes

contribute to its expression. Depending on locus or combination of loci, it can be

dominant, recessive, or somewhere in between. The strongest gene, IDDM1, is located

in the MHC Class II region on chromosome 6, at staining region 6p21. This is believed

to be responsible for the histocompatibility disorder characteristic of type 1: Insulin-

producing pancreas cells (beta cells) display improper antigens to T Cells. This

eventually leads to the production of antibodies that attack these beta cells. Weaker

genes are also located on chromosomes 11 and 18. Environmental factors can strongly

influence expression of type 1. A study showed that for identical twins, when one twin

had type 1 diabetes, the other twin only had type 1 30-50% of the time. Despite having

the exact same genome, one twin had the disease, where the other did not; this shows

that environmental factors, in addition to genetic factors, can influence disease

prevalence.

Treatment

Type 1 is treated with insulin replacement therapy — usually by injection

or insulin pump, along with attention to dietary management, typically including

carbohydrate tracking, and careful monitoring of blood glucose levels using Glucose

meters. Today the most common insulins are produced using genetic recombination

techniques; formerly, cattle or pig insulin were used, and even sometimes insulin from

fish. Major suppliers include Eli Lilly and Company, Novo-Nordisk, and Sanofi-

Aventis. A more recent trend, from several suppliers, is insulin analogs which are

slightly modified insulin are which have different onset of action times or duration of

action times. Untreated type 1 diabetes commonly leads to coma, often from diabetic

ketoacidosis, which is fatal if untreated. At present, insulin treatment must be continued

for life; this may perhaps change if better treatment, or a cure, becomes clinically

available. Continuous glucose monitors have been developed and marketed which can

alert patients to the presence of dangerously high or low blood sugar levels, but the

general lack of widespread insurance coverage (certainly in the US) and technical

limitations has limited the impact these devices have had on clinical practice so far.

In more extreme cases, a pancreas transplant can restore proper glucose regulation.

27

However, the surgery and accompanying immunosuppression required is considered by

many physicians to be more dangerous than continued insulin replacement therapy, and

is therefore often used only as a last resort (such as when a kidney must also be

transplanted, or in where the patient's blood glucose levels are extremely volatile).

Experimental replacement of beta cells (by transplant or from stem cells) is being

investigated in several research programs and may become clinically available in the

future. Thus far, beta cell replacement has only been performed on patients over age 18,

and with tantalizing successes amidst nearly universal failure.

Pancreas transplantation

Pancreas transplants are generally performed together with or some

time after a kidney transplant. One reason for this is that introducing a new kidney

requires taking immunosuppressive drugs anyway, and this allows the introduction of

a new, functioning pancreas to a patient with diabetes without any additional

immunosuppressive therapy. However, pancreas transplants alone can be wise in

patients with extremely labile type 1 diabetes mellitus.

Islet cell transplantation

Islet cell transplantation is expected to be less invasive than a pancreas

transplant which is currently the most commonly used approach in humans. In one

variant of this procedure, islet cells are injected into the patient liver, where they take up

residence and begin to produce insulin. The liver is expected to be the most reasonable

choice because it is more accessible than the pancreas, and islet cells seem to produce

insulin well in that environment.

The patient's body, however, will treat the new cells just as it would any other

introduction of foreign tissue, unless a method is developed to produce them from the

patient's own stem cells or there is an identify the available who can donate stem cells.

The immune system will attack the cells as it would a bacterial infection or a skin graft.

Thus, patients now also need to undergo treatment involving immunosuppressants, which

reduce immune system activity.

Recent studies have shown that islet cell transplants have progressed to the point that

58% of the patients in one study were insulin independent one year after islet cell

transplant. Ideally, it would be best to use islet cells which will not provoke this

immune reaction, but scientists in New Zealand are also looking into placing them

within a protective housing derived of sea-weed which enables insulin to flow out and

nutrients to flow in while protecting the islets from immune system attack via white

blood cells.

Prevalence

It is estimated that about 5%–10% of North American diabetes patients

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have type 1. The fraction of type 1 in other parts of the world differs; this is likely due

to both differences in the rate of type 1 and differences in the rate of other types, most

prominently type 2. Most of this difference is not currently understood. Variable criteria

for categorizing diabetes types may play a part.

Cure

As of 2009, there is no known cure for diabetes mellitus type 1 in

modern clinical use. Pancreas transplant is not practical (too few are available, and

pancreas transplant is technically difficult. The requirement for immuno- suppressive

drugs contributes to the unsatisfactory nature of pancreas transplant as a cure). Nor is a

cure known from any other source including traditional or alternative medical practice.

There is ongoing research on various approaches to curing diabetes type 1.

Diabetes type 1 is caused by the destruction of enough beta cells to produce symptoms;

these cells, which are found in the Islets of Langerhans in the pancreas, produce and

secrete insulin, the single hormone responsible for allowing glucose to enter from the

blood into cells (in addition to the hormone amylin, another hormone required for

glucose homeostasis).

Hence, the phrase "curing diabetes type 1" means "causing a maintenance or restoration

of the endogenous ability of the body to produce insulin in response

to the level of blood glucose" and cooperative operation with counter regulatory

hormones.

This section deals only with approaches for curing the underlying

condition of diabetes type 1, by enabling the body to endogenously, in vivo, produce

insulin in response to the level of blood glucose. It does not cover other approaches,

such as, for instance, closed-loop integrated glucometer/insulin pump products, which

could potentially increase the quality-of- life for some who have diabetes type 1, and

may by some be termed "artificial pancreas".

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Reversion

Encapsulation approach

Fig no : 2 Bio-artificial Pancreas sheet technology

The Bio-artificial pancreas: a cross section of bio-engineered tissue

with encapsulated islet cells delivering endocrine hormones in response to glucose.

A biological approach to the artificial pancreas is to implant bioengineered tissue

containing islet cells, which would secrete the amounts of insulin, amylin and

glucagon needed in response to sensed glucose.

When islet cells have been transplanted via the Edmonton protocol,

insulin production (and glycemic control) was restored, but at the expense of

continued immunosuppression drugs. Encapsulation of the islet cells in a protective

coating has been developed to block the immune response to transplanted cells, which

relieves the burden of immunosuppression and benefits the longevity of the transplant.

One concept of the bio-artificial pancreas uses encapsulated islet cells to build an islet

sheet which can be surgically implanted to function as an artificial pancreas.

This islet sheet design consists of an inner mesh of fibers to provide strength for the

islet sheet; islet cells, encapsulated to avoid triggering a proliferating immune

response, adhered to the mesh fibers; a semi-permeable protective layer around the

sheet, to allow the diffusion of nutrients and secreted hormones; a protective coating,

to prevent a foreign body response resulting in a fibrotic reaction which walls off the

sheet and causes failure of the islet cells. Islet sheet with encapsulation research is

pressing forward with large animal studies at the present, with plans for human

clinical trials within a few years.

30

Islet cell regeneration approach:

Research undertaken at the Massachusetts General Hospital between

2001 and 2003 demonstrated a protocol to reverse type 1 diabetes in non-obese

diabetic mice (a frequently used animal model for type 1 diabetes mellitus). Three

other institutions have had similar results, as published in the March 24, 2006 issue of

Science. A fourth study by the National Institutes of Health achieved similar results,

and also sheds light on the biological mechanisms involved.

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Gene therapy approach

Fig no : 3 DNA Gene therapy using an adenovirus

Gene therapy:

Designing a viral vector to deliberately infect cells with DNA to carry on

the viral production of insulin in response to the blood sugar level. Technology for gene

therapy is advancing rapidly such that there are multiple pathways possible to support

endocrine function, with potential to practically cure diabetes. Gene therapy can be used

to manufacture insulin directly: an oral medication, consisting of viral vectors

containing the insulin sequence, is digested and delivers its genes to the upper

intestines. Those intestinal cells will then behave like any viral infected cell, and will

reproduce the insulin protein. The virus can be controlled to infect only the cells which

respond to the presence of glucose, such that insulin is produced only in the presence of

high glucose levels. Due to the limited numbers of vectors delivered, very few

intestinal cells would actually be impacted and would die off naturally in a few

days. Therefore by varying the amount of oral medication used, the amount of insulin

created by gene therapy can be increased or decreased as needed. As the insulin

producing intestinal cells die off, they are boosted by additional oral medications.

32

Gene therapy might eventually be used to cure the cause of beta cell destruction,

thereby curing the new diabetes patient before the beta cell destruction is complete and

irreversible.

Gene therapy can be used to turn duodenum cells and duodenum adult

stem cells into beta cells which produce insulin and amylin naturally. By delivering beta

cell DNA to the intestine cells in the duodenum, a few intestine cells will turn into beta

cells and subsequently adult stem cells will develop into beta cells. This makes the

supply of beta cellsin the duodenum self replenishing, and the beta cells will produce

insulin in proportional response to carbohydrates consumed.

33

Prevention:

"Immunization" approach:

If a biochemical mechanism can be found that prevents the immune

system from attacking beta cells, it may be administered to prevent commencement of

diabetes type 1. Several groups are trying to achieve this by causing the activation

state of the immune system to change from Th1 state (―attack‖ by killer T Cells) to

Th2 state (development of new antibodies). This Th1-Th2 shift occurs via a change in

the type of cytokine signaling molecules being released by regulatory T-cells. Instead

of pro- inflammatory cytokines, the regulatory T-cells begin to release cytokines that

inhibit inflammation. This phenomenon is commonly known as "acquired immune

tolerance".

2) Type 2 diabetes:

Diabetes mellitus type 2 or type 2 diabetes (formerly called noninsulin-

dependent diabetes mellitus (NIDDM), or adult-onset diabetes) is a metabolic disorder

that is characterized by high blood glucose in the context of insulin resistance and

relative insulin deficiency. While it is often initially managed by increasing exercise

and dietary modification, medications are typically needed as the disorder progresses.

There are an estimated 23.6 million people in the U.S. (7.8% of the population) with

diabetes with 17.9 million being diagnosed, 90% of whom are type 2. With prevalence

rates doubling between 1990 and 2005, CDC has characterized the increase as an

epidemic. Traditionally considered a disorder of adults, type 2 diabetes is increasingly

diagnosed in children in parallel to rising obesity rates.

Unlike type 1 diabetes, there is little tendency toward ketoacidosis in type 2 diabetes,

though it is not unknown. One effect that can occur is nonketonic hyperglycemia which

also is quite dangerous, though it must be treated very differently. Complex and

multifactorial metabolic changes very often lead to damage and function impairment of

many organs, most importantly the cardiovascular system in both types. This leads to

substantially increased morbidity and mortality in both type 1 and type 2 patients, but

the two haven quite different origins and treatments despite the similarity in

complication

Pathophysiology:

Insulin resistance means that body cells do not respond appropriately

when insulin is present. Unlike type 1 diabetes mellitus, the insulin resistance is

generally "post-receptor", meaning it is a problem with the cells that respond to insulin

rather than a problem with production of insulin.

Other important contributing factors:increased hepatic glucose production (e.g., from

glycogen degradation), especially at inappropriate times (typical cause is deranged

34

insulin levels, as insulin controls this function in liver cells) decreased insulin-mediated

glucose transport in (primarily) muscle and adipose tissues (receptor and post-receptor

defects) impaired beta-cell function—loss of early phase of insulin release in response

to hyperglycemic stimuli Cancer survivors who received allogenic Hematopoietic Cell

Transplantation (HCT) are 3.65 times more likely to report type 2 diabetes than their

siblings. Total body irradiation (TBI) is also associated with a higher risk of developing

diabetes.

This is a more complex problem than type 1, but is sometimes easier to treat, especially

in the early years when insulin is often still being produced internally. Type 2 may go

unnoticed for years before diagnosis, since symptoms are typically milder (e.g., no

ketoacidosis, coma, etc) and can be sporadic. However, severe complications can result

from improperly managed type 2 diabetes, including renal failure, blindness, slow

healing wounds (including surgical incisions), and arterial disorder, including coronary

artery disorder. The onset of type 2 has been most common in middle age and later life,

although it is being more frequently seen in adolescents and young adults due to an

increase in screening programs. A type of diabetes called MODY is occasionally also

seen in adolescents, but this is classified as diabetes due to a specific cause and not as

type 2 diabetes.

Diabetes mellitus type 2 is presently of unknown etiology (i.e.,

origin). Diabetes mellitus with a known etiology, such as secondary to other

disorders, known gene defects, trauma or surgery, or the effects of drugs, is more

appropriately called secondary diabetes mellitus or diabetes due to a specific cause.

Examples include diabetes mellitus such as MODY or those caused by

hemochromatosis, pancreatic insufficiencies, or certain types of medications (e.g.

long-term steroid use).

The fraction of type 2 diabetics in other parts of the world varies substantially, almost

certainly for environmental and lifestyle reasons, though these are not known in detail.

Diabetes affects over 150 million people worldwide and this number

is expected to double by 2025. There is also a strong inheritable genetic connection in

type 2 diabetes: having relatives (especially first degree) with type 2 increases risks of

developing type 2 diabetes very substantially. In addition, there is also a mutation to

the Islet Amyloidal Polypeptide gene that results in an earlier onset, more severe, form

of diabetes. About 55 percent of type 2 are obese —chronic obesity leads to increased

insulin resistance that can develop into diabetes, most likely because adipose tissue

(especially that in the abdomen around internal organs) is a (recently identified) source

of several chemical signals to other tissues (hormones and cytokines). Other research

shows that type 2 diabetes causes obesity as an effect of the changes in metabolism

and other deranged cell behavior attendant on insulin resistance. Diabetes mellitus

type 2 is often associated with obesity, hypertension, elevated cholesterol (combined

hyperlipidemia), and with the condition often termed Metabolic syndrome (it is also

known as Syndrome X, Reavan's syndrome, or CHAOS). It is also associated with

35

acromegaly, Cushing's syndrome and a number of other endocrinological disorders.

Additional factors found to increase risk of type 2 diabetes include aging, high-fat

diets and a less active lifestyle.

Diagnosis

The World Health Organization definition of diabetes is for a single

raised glucose reading with symptoms otherwise raised values on two occasions, of

either: fasting plasma glucose ≥ 7.0 mmol/l (126 mg/dl)or With a Glucose tolerance

test, two hours after the oral dose a plasma glucose ≥ 11.1 mmol/l (200 mg/dl)

Screening and prevention

Prevention

Onset of type 2 diabetes can often be delayed through proper

nutrition and regular exercise. Interest has arisen in preventing diabetes due to

research on the benefits of treating patients before overt diabetes. Although the U.S.

Preventive Services Task Force concluded that "the evidence is insufficient to

recommend for or against routinely screening asymptomatic adults for type 2

diabetes, impaired glucose tolerance, or impaired fasting glucose, ―this was a grade I

recommendation when published in 2003. However, the USPSTF does recommend

screening for diabetics in adults with hypertension or hyperlipidemia (grade B

recommendation).

In 2005, an evidence report by the Agency for Healthcare Research and

Quality concluded that "there is evidence that combined diet and exercise, as well as

drug therapy (metformin, acarbose), may be effective at preventing progression to DM

in IGT subjects".

Accuracy of tests for early detection

If a 2-hour post loads glucose level of at least 11.1 mmol/L (≥ 200 mg/dL) is used as

the reference standard, the fasting plasma glucose > 7.0 mmol/L

(126 mg/dL) diagnoses current diabetes with:

sensitivity about 50%

specificity greater than 95%

A random capillary blood glucose > 6.7 mmol/L (120 mg/dL) diagnoses

current diabetes with:

sensitivity = 75%

specificity = 88%

Glycosylated hemoglobin values that are elevated (over 5%), but not in the diabetic

range (not over 7.0%) are predictive of subsequent clinical diabetes in US female

36

health professionals. In this study, 177 of 1061 patients with glycosylated hemoglobin

value less than 6% became diabetic within 5 years compared to 282 of 26281 patients

with a glycosylated hemoglobin value of

6.0% or more. This equates to a glycosylated hemoglobin value of 6.0% or more

having:

sensitivity = 16.7%

specificity = 98.9%

37

Benefit of early detection

Since publication of the USPSTF statement, a randomized controlled

trial of prescribing acarbose to patients with "high-risk population of men and women

between the ages of 40 and 70 years with a body mass index (BMI), calculated as

weight in kilograms divided by the square of height in meters, between 25 and 40.

They were eligible for the study if they had IGT according to the World Health

Organization criteria, plus impaired fasting glucose (a fasting plasma glucose

concentration of between 100 and 140 mg/dL or 5.5 and 7.8 mmol/L) found a number

needed to treat of 44 (over 3.3 years) to prevent a major cardiovascular event. Other

studies have shown that lifestyle changes, xenical and metformin can delay the onset o f

diabetes.

Treatment:

Diabetes mellitus type 2 is a chronic, NON-progressive disorder that

has no established cure, but does have well-established treatments which can delay or

prevent entirely the formerly inevitable consequences of the condition. Often, the

disorder is viewed as progressive since poor management of blood sugar leads to a

myriad of steadily worsening complications. However, if blood sugar is properly

maintained, then the disorder is effectively cured - that is, patients are at no heightened

risk for neuropathy, blindness, or any other high blood sugar complication. There are

two main goals of treatment:

1. reduction of mortality and concomitant morbidity (from assorted diabetic

complications)

2. preservation of quality of life

The first goal can be achieved through close glycemic control (i.e., to

near 'normal' blood glucose levels); the reduction in severity of diabetic side effects has

been very well demonstrated in several large clinical trials and is established beyond

controversy. The second goal is often addressed (in developed countries) by support and

care from teams of diabetic health workers (usually physician, PA, nurse, dietitian or a

certified diabetic educator). Endocrinologists, family practitioners, and general

internists are the physician specialties most likely to treat people with diabetes.

Knowledgeable patient participation is vital to clinical success, and so patient education

is a crucial aspect of this effort. Type 2 is initially treated by adjustments in diet and

exercise, and by weight loss, most especially in obese patients. The amount of weight

loss which improves the clinical picture is sometimes modest (2-5 kg or 4.4-11 lb); this

is almost certainly due to currently poorly understood aspects of fat tissue activity, for

instance chemical signaling. In many cases, such initial efforts can substantially restore

insulin sensitivity. In some cases strict diet can adequately control the glycemic levels.

38

Treatment goals

Treatment goals for type 2 diabetic patients are related to effective

control of blood glucose, blood pressure and lipids to minimize the risk of long-term

consequences associated with diabetes. They are suggested in clinical practice

guidelines released by various national and international diabetes agencies.

The targets are:

HbA1c of 6% to 7.0% Preprandial blood glucose: 4.0 to 6.0 mmol/L (72 to 108 mg/dl)

2-hour postprandial blood glucose: 5.0 to 8.0 mmol/L (90 to 144 mg/dl) In older

patients, clinical practice guidelines by the American Geriatrics Society states "for frail

older adults, persons with life expectancy of less than 5 years, and others in whom the

risks of intensive glycemic control appear to outweigh the benefits, a less stringent

target such as 8% is appropriate".

39

Self monitoring of blood glucose

Self-monitoring of blood glucose may not improve outcomes in some

cases that are among "reasonably well controlled non-insulin treated patients with type

2 diabetes". Nevertheless, it is very strongly recommended for patients in whom it can

assist in maintaining proper glycemic control, and is well worth the cost (sometimes

considerable) if it does. It is the only source of current information on the glycemic

state of the body, as changes are rapid and frequent, depending on food, exercise, and

medication, and secondarily, on time of day, stress, infection, etc.

Self management

Diabetes self-management education is an integral component of

medical care. Among adults with diagnosed diabetes, 12% take both insulin and oral

medications,19% take insulin only, 53% take oral medications only, and 15% do not

take either insulin or oral medications.

Traditionally, information regarding diabetes would be obtained from a family

physician. This information can be beneficial, but care must be taken to ensure the

information is medically sound. Several of the external links below provide

information about diabetes and its management, including self-management.

Ant diabetic drugs:

There are several drugs available for type 2 diabetics -- most are

unsuitable or even dangerous for use by type 1 diabetics. They fall into several

classes and are not equivalent, nor can they be simply substituted one for another. All

are prescription drugs.

Oral drugs:

A systematic review of randomized controlled trials found that

metformin and second-generation sulfonylurea‘s are the preferred choices for most

with type 2 diabetes, especially those early in the course of the disorder. Failure o f

response after a time is not unknown with most of these agents: the initial choice o f

anti-diabetic drug has been compared in a randomized controlled trial which found

"cumulative incidence of monotherapy failure at 5 years to be 15% with rosiglitazone,

21% with metformin, and 34% with glyburide". Of these, rosiglitazone users showed

more weight gain and edema than did non-users.

40

Rosiglitazone may increase risk of death from cardiovascular causes

though the causal connection is unclear. Pioglitazone and rosiglitazone may also

increase the risk of fractures. For patients who also have heart failure, metformin may

be the best tolerated drug.

Injectable peptide analogs

DPP-4 inhibitors lowered A1C by 0.74%, comparable to other ant

diabetic drugs. GLP-1 analogs resulted in weight loss and had more gastrointestinal

side effects, while DPP-4 inhibitors were weight neutral and increased risk for

infection and headache, but both classes appear to present an alternative to other ant

diabetic drugs.

Insulin preparations

If ant diabetic drugs fail (i.e., the clinical benefit stops), insulin

therapy may be necessary – usually in addition to oral medication therapy – to

maintain normal or near normal glucose levels.

Typical total daily dosage of insulin is 0.6 U/kg. But, of course,

best timing and indeed total amounts depend on diet as well the degree of insulin

resistance. More complicated estimations to guide initial dosage of insulin are:

For men, [(fasting plasma glucose [mmol/liter]–5)x2] x (weight

[kg]÷(14.3xheight [m])–height [m]) For women, [(fasting plasma glucose [mmol/liter]–

5)x2] x (weight [kg]÷(13.2xheight [m])–height [m])

The initial insulin regimens are often chosen based on the patient's blood glucose

profile. Initially, adding nightly insulin to patients failing oral medications may be

best. Nightly insulin combines better with metformin than with sulfonylureas. The

initial dose of nightly insulin (measured in IU/d) should be equal to the fasting blood

glucose level (measured in mmol/L). If the fasting glucose is reported in mg/dl,

multiply by 0.05551 to convert to mmol/L.

When nightly insulin is insufficient, choices include :

Premixed insulin with a fixed ratio of short and intermediate acting

insulin; this tends to be more effective than long acting insulin, but is associated with

increased hypoglycemia. Initial total daily dosage of biphasic insulin can be 10 units if

the fasting plasma glucose values are less than 180 mg/dl or 12 units when the fasting

plasma glucose is above 180 mg/dl". A guide to titrating fixed ratio insulin is available.

Long acting insulin‘s such as insulin glargine and insulin detemir. A

meta-analysis of randomized controlled trials by the Cochrane Collaboration found

"only a minor clinical benefit of treatment with long-acting insulin analogues for

patients with diabetes mellitus type 2". More recently, a randomized controlled trial

found that although long acting insulin were less effective, they were associated with

41

reduced hypoglycemic episodes.

Antihypertensive agents

The goal blood pressure is 130/80 which is lower than in non-diabetic patients.

ACE inhibitors

The HOPE study suggests that diabetics should be treated with ACE inhibitors

(specifically ramipril 10 mg/d) if they have one of the following:

Hypertension hypercholesterolemia or reduced low high-density lipoprotein

cholesterol levels cigarette smoking microalbuminuria. After treatment with

ramipril for 5 years the number needed to treat was 50 patients to prevent one

cardiovascular death. Other ACE inhibitors may not be as effective.

Hypolipidemic agents

1) Gastric bypass surgery

Gastric Bypass procedures are currently considered an elective

procedure with no universally accepted algorithm to decide who should have the

surgery. In the diabetic patient, certain types result in 99-100% prevention of insulin

resistance and 80-90% clinical resolution or remission of type 2 diabetes. In 1991, the

NIH (National Institute of Health) Consensus Development Conference on

Gastrointestinal Surgery for Obesity proposed that the body mass index (BMI)

threshold to consider surgery should drop from 40 to 35 in the appropriate patient.

A study of 20-years of Greenville gastric bypass patients found that

80% of those with type 2 diabetes before surgery no longer required insulin or oral

agents to maintain normal glucose levels. Weight loss occurred rapidly in many people

in the study who had had the surgery. The 20% who did not respond to bypass surgery

were, typically, those who were older and had diabetes for over 20 years

2) Suspected action mechanism

The effectiveness of gastric bypass surgery in type 2 remission

was long thought to be due to weight loss. When it was discovered that rats whose

duodenum and upper lower intestine were removed also showed the type 2 remission

effect, and when this was also observed in humans, the suspicion arose that some

signal originating in the excised tissue was responsible for the development or

maintenance of type 2's insulin resistance. When that signal is removed, body cells

revert to normal behavior and lose their insulin insensitivity.

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3) Gestational Diabetes

Gestational diabetes is a form of diabetes which affects

pregnant women. It is believed that the hormones produced during pregnancy reduce

a woman's receptivity to insulin, leading to high blood sugar levels. Gestational

diabetes affects about 4% of all pregnant women. It is estimated that about 135,000

cases of gestational diabetes arise in the United States each year.

Hormones involved in development of placenta, which helps the

baby to develop also blocks, the action of the mother's insulin in her body. This

problem is called insulin resistance. During pregnancy a mother may need up to

three times more insulin for glucose to leave the blood and transform to energy.

When body is not able to use insulin due to insulin resistance it develops into

Gestational Diabetes. Glucose builds up in the blood to high level, it is called

hyperglycemia. Gestational diabetes affects the mother in late pregnancy and the

baby too. Insulin does not cross the placenta, as glucose and other nutrients do.

Extra blood glucose passes through the placenta that gives the baby a high blood

glucose level. It results the baby's pancreas to make extra insulin to get rid of the

blood glucose. Since the baby is getting more energy than it needs to develop and

grow, the extra energy is stored as fat.

It can lead to Macrosomia i.e. ―Fat‖ baby. At birth this fat baby develops

problem in breathing or may develop hypoglycemia due to over production of

insulin.

Causes of Diabetes

The precise Etiology of most cases of diabetes is uncertain, although

certain contributing factors are as follows:

Type 1 diabetes

Type 1 Diabetes is autoimmune disorder that affects 0.3% on average. It is result o f

destruction of beta cells due to aggressive nature of cells present in the body.

Researchers believe that some of the Etiology and Risk factors which may trigger

type 1 diabetes may be genetic, poor diet (malnutrition) and environment (virus

affecting pancreas).

Secondly, in most of the cases, diabetes occurs because there is abnormal secretion

of some hormones in blood which act as antagonists to insulin. Example :

Adrenocortical hormone, Adrenaline hormone and Thyroid hormone.

Type 2 diabetes

Type 2 Diabetes is also called non insulin-dependent diabetes mellitus (NIDDM) or

adult-onset diabetes. It occurs when the body produces enough insulin but cannot

utilize it effectively. This type of diabetes usually develops in middle age. A general

observation says that about 90-95 % of

people suffering with diabetes are type 2; about 80 percent are overweight. It is more

43

common among people who are older; obese; have a family history of diabetes; have

had gestational diabetes. There are number of risk factors found to be responsible for

type 2 diabetes like, the more the Etiology and Risk factors carried by an individual, he

higher the risk for developing diabetes.

Following are the Causes of Diabetes

Hereditary or Inherited Traits :

It is strongly believed that due to some genes which pass from one generation to

another, a person can inherit diabetes. It depends upon closeness of blood relationship as

mother is diabetic, the risk is 2 to 3%, father is diabetic, the risk is more than the

previous case and if both the parents are diabetic, the child has much greater risk for

diabetes.

Age:

Increased age is a factor which gives more possibility than in younger age. This

disorder may occur at any age, but 80% of cases occur after 50 year, incidences

increase with the age factor.

Poor Diet (Malnutrition Related Diabetes) :

Improper nutrition, low protein and fiber intake, high intake of refined products are

the expected reasons for developing diabetes.

Obesity and Fat Distribution:

Being overweight means increased insulin resistance that is if body fat is more than

30%, BMI 25+, waist grith 35 inches in women or 40 inches in males.

Sedentary Lifestyle:

People with sedentary lifestyle are more prone to diabetes, when compared to those

who exercise thrice a week, are at low risk of falling prey to diabetes.

Stress:

Either physical injury or emotional disturbance is frequently blamed as the initial

cause of the disorder. Any disturbance in Cortiosteroid or ACTH therapy may lead

to clinical signs of the disorder.

Drug Induced:

44

Clozapine (Clozaril), olanzapine (Zyprexa), risperidone (Risperdal),

quetiapine (Seroquel) and ziprasidone (Geodon) are known to induce this

lethal disorder.

Infection:

Some of the strephylococci is suppose to be responsible factor for infection in

pancreas.

Sex :

Diabetes is commonly seen in elderly especially males but, strongly in women and

those females with multiple pregnancy or suffering from (PCOS) Polycystic

Ovarian Syndrome.

Hypertension:

It had been reported in many studies that there is direct relation between high systolic

pressure and diabetes. Serum lipids and lipoproteins: High triglyceride and cholesterol

level in the blood is related to high blood sugars, in some cases it has been studied that

risk is involved even with low HDL levels in circulating blood.

Poverty:

Researchers have uncovered a link between poverty and diabetes. In a survey in the

USA, households with the lowest income- under $15,000- was found to have the

highest incidence of diabetes.

Diabetics Symptoms

In both types of diabetes, signs and symptoms are more likely to be similar

as the blood sugar is high, either due to less or no production of insulin, or insulin

resistance. In any case, if there is inadequate glucose in the cells, it is identifiable

through certain signs and symptoms. These symptoms are quickly relieved once the

Diabetes is treated and also reduce the chances of developing serious health problems.

Diabetes is caused by insufficient insulin entering the bloodstream to

regulate the glucose. It is either caused by cells in the pancreas dying off or receptor

sites clogged up by fat and cholesterol. In some case diabetes is also caused by allergy

reactions of cells in our body. If anybody have the below symptoms, please check with

your family doctor.

45

1. Frequent urination:

If you feel that you are needing to urinate more often than usual or a

compelling urge to urinate, along with discomfort in your bladder.

2. Excessive thirst:

The urge to drink too much beyond a certain limit may be a symptom of high

blood sugar in your bloodstream, and can be an important clue in detecting

diabetes.

3. Increase appetite:

If you are experiencing the drive to eat excessively due to emotional and

physical causes then it is an emotion disorder that compels you to eat even after you

are full. Increased appetite can be an early symptom of diabetes.

4. Unexplained weight loss:

Loss of body weight can occur due to various conditions ranging from eating disorders

to severe metabolic conditions including diabetes. Drastic weight loss of more than 5

to 10 pounds when you're not trying to requires medical attention because it may be a

sign of diabetes.

5. Blurry vision:

This is a symptom of great concern. If the blood sugar levels are too high, sugar builds

up in your eye, this excess sugar also draws in fluid, changing the shape of the lens and

making blurry vision. Certain types of blurry vision can be a medical emergency where

delay can lead to loss of sight.

6. Increased fatigue:

Unlike the tiredness experienced by a healthy person, sudden increase of fatigue

is a bad thing in people with symptoms of diabetes.

Most Type II diabetes is caused by uncontrolled diets that are high in saturated

fat. In the case of the cells of the pancreas dying off, experts believe it is caused

by excessive drinking of alcohol.

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Diabetic Care

Diabetes can be a tough disorder to handle. There are many reasons for it, firstly,

causes of the disorder are not clearly known, it is difficult to prevent. Secondly, once

you get the disorder, it is not possible to cure the same and

you need to take care of your health for entire life. This task can be quite daunting;

here are a few tips.

Diabetic Care Tips

If you have diabetes, you need to take some precautions, in your day

to day life as well and not only at those times, when you feel sick. Here are some

precautions that you can take in your everyday life:

You should monitor your blood glucose level regularly. Depending on the severity of

your condition, your doctor would tell you about the intervals, in which you should take

the test. You should take regular doses of medicine or insulin, as have been prescribed.

Regular exercise proves to be useful in controlling glucose levels.

However, you should avoid few exercises, that are known to cause further complications

like cardiovascular disorders, hypoglycemia etc. In case your glucose level drops

suddenly during or after exercise, you should consume a fruit juice or some similar

drink that provides you with sugar. Weight reduction is a key of success in managing

diabetes; hence take all the measures of carb control, what you can. In case you are

suffering from any ailment like flu, cold or any other disorder or infection, some extra

precautions need to be taken, to avoid further complications by diabetes:

Check your blood sugar level more frequently, to ensure that no harm is being caused

by diabetes. The illness may force some changes in your diet; consult your

doctor/endocrinologist about the changes you need to make in your diabetes medicine

accordingly.

You should drink lots of water and other clear liquids. Remember not to cut yourself

completely from food even if you are not experiencing hunger. Consult the doctor, if

you feel abnormal in any manner. For example you may be feeling excessively sleepy,

giddy, may have trouble with urination etc.

Even though diabetes is a chronic condition, the same does not mean, that you will

have to avoid every activity you enjoy, once you contract it. You can have the same

amount of fun, provided, that you take certain precautions. Remember, if you have

diabetes, you cannot ignore the precautions, nor do you need to get bogged down

completely by them.

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Diabetes Care

Eat food at fixed hours

Do not overeat

Do not eat immediately after a workout

Make sure you have three proper meals & light snacks in between

Eat about the same amounts of food each day

Eat your meals and snacks at about the same times each day

Make sure the gaps between your meals are short

Do not eat fast; masticate and munch your food well before you swallow

Drink a lot of water that will help flush the toxins off your system

Avoid fried foods and sweetmeats

Include fresh vegetable salad in every meal

Include sprouts in the diet

Take your medicines at the same times each day

Exercise at about the same times each day

Avoid smoking. Smoking leads to heart disorder and poor circulation Check

your feet for cuts, blisters,

and swelling which are likely to result from diabetes-related nerve damage

Try to stick up to the plan made up for sugar control

Check the other tests such as kidney function, liver function, heart function,

ketone level etc

Check your weight periodically and maintain ideal body weight

Diabetes Diet

Diet plays a significant role in controlling the diabetes. The

diabetic diet may be used alone or else in combination with insulin doses or with

oral hypoglycemic drugs. Main objective of diabetic diet is to maintain ideal

body weight, by providing adequate nutrition along with normal blood sugar

levels in blood. The diet plan for a diabetic is based on height, weight, age, sex,

physical activity and nature of diabetes. While planning diet, the dietician has to

consider complications such as high blood pressure, high cholesterol levels. With

respect to the above factors, a dietician will assess calories to be given, like

scheming the carbohydrates, proteins, fats, type of carbohydrate, amount of fiber

and so on. Exchange meal plan is a diet program which balances the amount of

carbohydrate that we intake per day. Glucose is a sugar released from

carbohydrate so, if we want to control blood sugar we have to limit the

consumption of simple carbohydrate.

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Carbohydrate foods are given as value per portion, known as the

exchange. This plan helps us to decide on the type of food to be taken, the amount of

food and also the time to eat. You can plan for more flexible meals as you get more

knowledge about the diet for a diabetic, may be like the counting carbohydrate meal

plan or constant carbohydrate. But there is no common diet that works for everyone.

Nor is there any particular diet that works perfectly for any diabetic over a long period.

While planning diabetes diet we should adhere to certain important factors, they are as

follows:

Fiber should be at least 1.4 oz / day Instead of 3 heavy meals, we should go for 4-5 small

mid intervals Replace bakery products and fast foods by simple whole cooked cereals,

and don't eat carbohydrates 2 hours before bedtime Consume fresh fruit and vegetables

at least 5 exchange/ day Diabetics always need to take care of their diet and also about

the food they eat. Care has to be taken because all foods contain not only carbohydrate,

but also some energy value. Protein and fat available in the food are converted to glucose

in the body. This glucose has some effect on the blood sugar level, which has to be taken

care of.

Furthermore, you needn‘t have to eat only the bland boring diet. Instead, you can eat

more fruits, vegetables and whole grains.

Diabetic Food Pyramid

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Fats (Limit to 1 serving per meal) a serving can be:-

10 Peanuts.

1 Tbsp Salad Dresssing

2 Tbsp light salad dressing or saur cream.

1 Tsp margarine, Oil or mayonnaise.

1/8 Avocado.

Sweets (Substitute for starch or fruit serving occasionally) A serving can be:-

2 Small Cookies.

1 Small Cupcake or Muffin

½ Cup Ice cream.

1/3 Cup Frozen Yoghurt.

¼ Cup Sherbet.

1 tsp Syrup or Honey.

Milk (2-3 Servings per day) A serving can be:

1 cup Milk.

1 Cup Low Fat.

1 Cup Artificially Sweetened yogurt (No sugar)

Meat / Fish/Chicken (2-3 Serving per day) A serving can be:

2 oz Cooked Lean Meat/Poultry/Fish.

½ - ¾ Cup Tuna or Cottage Cheese.

1 Egg or 4 oz Tofu or 1 oz cheese.

2 Tbsp peanut Butter.

Vegetables (3-5 Serving Per day) A Serving can be:

1 Cup Raw Vegetables.

½ Cup Cooked Vegetables.

½ Cup Tomato or Vegetable Juice. Fruits (3

Serving per Day) A Serving Can be:

70 gm small fruit.

½ Cup canned fruit.

¼ cup Dried Fruit.

½ Cup Fruit Juice. (No sugar)

Grains, Starchy Vegetables and Beans. (6 plus Servings Per Day) A Serving

Can be:-

1 Slice of 1 oz bread or ½ (1 oz) Bagel or 5 Crackers or 1 Granola bar.

½ Hamburger or Hot dog Bun or a tortilla of 6 inch or 2 tacos.

½ Cup Cooked Cereal, Cooked beans, Lentils, Corn, Peas, S. Potato, Potato

or Pasta.

1 Cup winter Squash, 1 Cup Soup.

1/3 Cup Rice or 3 Cup Plain Popcorn (Fat free)

Avoid the following food items when planning a diabetes diet:

a) Starchy foods such as white bread, pasta and potatoes

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b) Sugars such as table sugar, honey, fruits and sweets

c) Artificially sweetened juices

d) Fried and processed food

e) Reduce salt intake.

The essential ingredients of a diabetic diet include the following:

a) Carbohydrates

b) Proteins

c) Fibers

d) Saturated fats

Monitoring Diabetes - All about Diabetes

Now that you've been told you have diabetes you'll have to monitor

blood sugar levels and control your glucose level. Your glucose level is based on

the amount of blood sugar in your bloodstream. In basic terms, glucose is found in

the foods we eat, so having a proper diet is obviously a very important part o f

controlling the glucose levels in your bloodstream.

The medical experts agree in saying that your diet and getting regular

exercise are the biggest keys in keeping diabetes under control. Many doctors will

even tell you that diet alone can control Type 2 Diabetes. You will be told what kind

of diet you need to be on based upon your type of diabetes and your body type. You

might want to get a diabetes cook book to get a healthy body and heart. If you have

been diagnosed with Type 1 Diabetes, the best way of controlling it is to test your

glucose levels regularly - as instructed by your doctor - and take the correct level of

medication or insulin.

Since a diabetics body can't produce insulin, as in Type 1 diabetes, or cannot

process the insulin that it does make, which is found in Type 2 diabetes, these blood

sugar levels can vary much more then those of a person in perfect health.

Diabetics afflicted with Type 1 Diabetes should be checking

their blood sugar levels daily before eating. The number of tests each day should a

minimum of 2 times per day, but some patients may need as

many as 6 tests in a day. These tests help determine how much insulin needs to be

taken into the body to help process the glucose. Type 2 diabetics are able to contro l

their diabetes with drugs and dieting However they too need to monitor their blood

sugar levels a few times a week. This should be done immediately after eating a meal

or up to 90 minutes after eating. In addition,

it is a good idea to check your levels before every meal around one day a month

to see exactly how your body interacts with the food that you eat. Are you having

trouble coming up with healthy recipes to cook? You can find a number of diabetes

cook books that are not only healthy for your body, but your heart as well. To check

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your blood sugar levels, the most commonly used method of obtaining a blood sample

is to prick the finger. You then take the blood that is released and put it onto a testing

strip, which comes with blood sugar level testing kits. This strip is then put into a

measuring device, and processed for around 30 seconds before a result is achieved.

But there is some good news!

Lots of research is on going and a new gadget is now available that checks a diabetics

blood sugar and lets them know if it falls to a dangerous low. Researchers have been

searching for the gadget for years. Monitoring devices are now coming on the market

and by late summer will be available in the United States.

These monitors are not as accurate as "normal" blood tests, finger

lances, but researchers are hoping that within a couple of years it will allow a diabetic

to forgo putting their finger to test for blood glucose levels. If the monitor signals that

blood sugar levels are low, it is necessary to take a blood test for confirmation. The

monitors are also slow to show rapid changes that occur, especially when you

exercise.

This monitor is working to make finger lances outdated for all diabetics. Those

who have used the monitors report little discomfort. A patch worn on the abdomen

may hurt when it goes on because there is a tiny wire placed under the skin to

measure the glucose in cell fluid. Once the patch is on, it is comfortable to wear and

sends information to a receiver. The receiver is about the size of a cell phone.

Researchers are working toward pairing the new monitoring device

to insulin pumps. These pumps have been on the market for years and could reduce

the time needed for controlling diabetes to a minimum. One such product has already

been approved in last year in April and is now offered for sale now.

The monitoring portion of the device will be available until later this summer, so it

isn't fully automatic yet, but it is promising news for those who are trying to contro l

Type 1 or Type 2 diabetes.

Another new treatment going through trials is the delivery of insulin through

inhalation. The insulin is prepared in a dry micro fine powder form which is inhaled

directly into the lungs from where it is absorbed into the blood stream.

Diagnosis

Diabetes is suspected based on symptoms. Urine tests and blood tests

can be used to confirm a diagnose of diabetes based on the amount of glucose in the

urine and blood. Urine tests can also detect ketones and protein in the urine which may

help diagnose diabetes and assess how well the kidneys are functioning. These tests

can also be used to monitor the disorder once the patient is on a standardized diet, oral

52

medications, or insulin.

Brief about Diabetes product

Anti-diabetic drug

Anti-diabetic drugs treat diabetes mellitus by lowering glucose levels

in the blood. With the exceptions of insulin, exenatide, and pramlintide, all are

administered orally and are thus also called oral hypoglycemic agents or oral

antihyperglycemic agents. There are different classes of anti-diabetic drugs, and their

selection depends on the nature of the diabetes, age and situation of the person, as well

as other factors. Diabetes mellitus type 1 is a disorder caused by the lack of insulin.

Insulin must be used in Type I, which must be injected or inhaled. Diabetes mellitus

type 2 is a disorder of insulin resistance by cells. Treatments include (1) agents which

increase the amount of insulin secreted by the pancreas, (2) agents which increase the

sensitivity of target organs to insulin, and (3) agents which decrease the rate at which

glucose is absorbed from the gastrointestinal tract. Several groups of drugs, mostly

given by mouth, are effective in Type II, often in combination. The therapeutic

combination in Type II may include insulin, not necessarily because oral agents have

failed completely, but in search of a desired combination of effects.

The great advantage of injected insulin in Type II is that a well-educated patient can

adjust the dose, or even take additional doses, when blood glucose levels measured by

the patient, usually with a simple meter, as needed by the measured amount of sugar in

the blood.

Insulin

Insulin is usually given subcutaneously, either by injections or by an

insulin pump. Research is underway of other routes of administration. In acute care

settings, insulin may also be given intravenously. There are several types of insulin,

characterized by the rate which they are metabolized by the body.

Secretagogues

Sulfonylureas

Sulfonylureas were the first widely used oral hypoglycemic

medications. They are insulin secretagogues, triggering insulin release by direct action

on the KATP channel of the pancreatic beta cells. Eight types of these pills have been

marketed in North America, but not all remain available. The "second- generation"

drugs are now more commonly used. They are more effective than first-generation

drugs and have fewer side effects. All may cause weight gain.

Sulfonylureas bind strongly to plasma proteins. Sulfonylurea‘s are only useful in

Type II diabetes, as they work by stimulating endogenous release of insulin. They

work best with patients over 40 years old, who have had diabetes mellitus for under

53

ten years. They can not be used with type I diabetes, or diabetes of pregnancy. They

can be safely used with metformin or -glitazones. The primary side effect is

hypoglycemia.

First-generation agents

o tolbutamide (Orinase)

o acetohexamide (Dymelor)

o tolazamide (Tolinase)

o chlorpropamide (Diabinese)

Second-generation agents

o glipizide (Glucotrol)

o glyburide (Diabeta, Micronase, Glynase)

o glimepiride (Amaryl)

o gliclazide (Diamicron)

Meglitinides

Meglitinides help the pancreas produce insulin and are often called

"short- acting secretagogues." Their mode of action is original, affecting potassium

channels. By closing the potassium channels of the pancreatic beta cells, they open

the calcium channels, hence enhancing insulin secretion.

They are taken with meals to boost the insulin response to each meal.

repaglinide (Prandin) - The maximum dosage is 16 mg/day, taken 0 to

30 minutes before meals. If a meal is skipped, the medication is also skipped.

nateglinide (Starlix) - The maximum dosage is 360 mg/day, usually

120 mg three times a day (TID). It also follows the same

recommendations as repaglinide.

Adverse reactions include weight gain and hypoglycemia.

Sensitizers

Biguanides

Biguanides reduce hepatic glucose output and increase uptake of

glucose by the periphery, including skeletal muscle. Although it must be used with

caution in patients with impaired liver or kidney function, metformin has become the

most commonly used agent for type 2 diabetes in children and teenagers.

Amongst common diabetic drugs, metformin, a biguanide, is the only widely used oral

drug that does not cause weight gain.

metformin (Glucophage). Metformin may be the best choice for patients

who also have heart failure.

phenformin (DBI): used from 1960s through 1980s, withdrawn due to lactic

acidosis risk.

buformin: also withdrawn due to lactic acidosis risk.

54

Metformin should be temporarily discontinued before any radiographic

procedure involving intravenous iodinated contrast as patients are at an increased

risk of lactic acidosis.

Metformin is usually the first-line medication used for treatment of type-2 diabetes.

Initial dosing is 500 mg twice daily, but can be increased up to 1000 mg twice daily.

It is also available in combination with other oral diabetic medications.

Thiazolidinediones

Thiazolidinediones (TZDs), also known as "glitazones," bind to PPARγ, a

type of nuclear regulatory proteins involved in transcription of genes regulating

glucose and fat metabolism. These PPARs act on Peroxysome Proliferator Responsive

Elements (PPRE). The PPREs influence insulin sensitive genes, which enhance

production of mRNAs of insulin dependent enzymes. The final result is better use of

glucose by the cells.

rosiglitazone (Avandia)

pioglitazone (Actos)

troglitazone (Rezulin): used in 1990s, withdrawn due to hepatitis and liver

damage risk.

As a result of multiple retrospective studies, there is a concern about rosiglitazone's

safety, although it is established that the group, as a whole, has beneficial effects on

diabetes. The greatest concern is an increase in the number of severe cardiac events in

patients taking it. The ADOPT study showed that initial therapy with drugs of this

type may prevent the progression of disorder, as did the DREAM trial.

In contrast, at least one large prospective study, PROactive 05, has shown that

pioglitazone may decrease the overall incidence of cardiac events in people with type

II diabetes who have already had a heart attack.

Alpha-glucosidase inhibitors

Alpha-glucosidase inhibitors are "diabetes pills" but not technically

hypoglycemic agents because they do not have a direct effect on insulin secretion or

sensitivity. These agents slow the digestion of starch in the small intestine, so that

glucose from the starch of a meal enters the bloodstream more slowly, and can be

matched more effectively by an impaired insulin response or sensitivity.

These agents are effective by themselves only in the earliest stages of impaired

glucose tolerance, but can be helpful in combination with other agents in type 2

diabetes.

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miglitol (Glyset)

acarbose (Precose/Glucobay)

These medications are rarely used in the United States because of the severity

of their side effects (flatulence and bloating). They are more commonly

prescribed in Europe. They do have the potential to cause weight loss by

lowering the amount of sugar metabolized.

Peptide analogs

Overview of insulin secretion

Incretin mimetics

Incretins are insulin secretagogues. The two main candidate molecules that fulfill

criteria for being an incretin are Glucagon- like peptide-1 (GLP-1) and Gastric

inhibitory peptide (aka glucose-dependent Insulinotropic peptide or GIP). Both GLP-1

and GIP are rapidly inactivated by the enzyme dipeptidyl peptidase-4 (DPP-4).

Glucagon-like peptide (GLP) analogs and agonists

GLP agonists bind to a membrane GLP receptor. As a consequence of this, insulin

release from the pancreatic beta cells is increased. Endogenous GLP has a half life of

only a few minutes; thus an analogue of GLP would not be practical.Exenatide (also

Exendin-4, marketed as Byetta) is the first GLP-1 agonist approved for the treatment

of type 2 diabetes. Exenatide is not an analogue of GLP, but rather a GLP agonist.

Exenatide has only 53% homology with GLP, which increases its resistance to

degradation by DPP-4 and extends its half- life.

Liraglutide, a once daily human analogue (97% homology), is being developed by

Novo Nordisk. As of 2007, it is in phase III clinical trials. These agents may also

cause a decrease in gastric motility, responsible for the common side effect of nausea,

and is probably the mechanism by which weight loss occurs.

Gastric inhibitory peptide (GIP) analogs

None are FDA approved

DPP-4 inhibitors

Dipeptidyl peptidase-4 (DPP-4) inhibitors increase blood concentration of the incretin

GLP-1 (glucagon-like peptide-1) by inhibiting its degradation by dipeptidyl peptidase-4

(DPP-4). Examples are:

vildagliptin

sitagliptin

56

Amylin analogues

Amylin agonist analogues slow gastric emptying and suppress

glucagon. They have all the incretins actions except stimulation of insulin secretion. As

of 2007, pramlintide is the only clinically available amylin analogue. Like insulin, it is

administered by subcutaneous injection. The most frequent and severe adverse effect of

pramlintide is nausea, which occurs mostly at the beginning of treatment and gradually

reduces.

Experimental agents

Many other potential drugs are currently in investigation by pharmaceutical

companies. Some of these are simply newer members of one of the above classes, but

some work by novel mechanisms. For example, at least one compound that enhances

the sensitivity of glucokinase to rising glucose is in the stage of animal research. Others

are undergoing phase I/II studies.

PPARα/γ ligands (muraglitazar and tesaglitazar - development stopped

due to adverse risk profile, aleglitazar - under clinical development) s

SGLT (sodium-dependent glucose transporter 1) inhibitors increase urinary

glucose. FBPase (fructose 1,6-bisphosphatase) inhibitors decrease

gluconeogenesis in the liver.

Herbal extracts

A recent review article presents the profiles of plants with

hypoglycaemic properties, reported in the literature from 1990 to 2000 and states that

"Medical plants play an important role in the management of diabetes mellitus

especially in developing countries where resources are meager."Animal studies have

found that walnut leaf and garlic can significantly reduce fasting blood glucose levels

in rats with alloxan- induced diabetes.

Myrcia

The first registered use of anti-diabetic drugs was as herbal extracts

used by Indians in the Amazon Basin for the treatment of type 2 diabetes, and today

promoted as vegetable insulin although not formally an analog. The major recent

development was done in Brazil around Myrcia sphaerocarpa and other Myrcia

species. "Many countries, especially in the developing world, have a long history of the

use of herbal remedies in diabetes (...) STZ diabetic rats were also used to test Myrcia

Uniflora extracts (...) ". The usual treatment is with concentrated (root) Myrcia extracts,

commercialized in a 4 US dollar per kilogram packed rocks (~100 times cheaper than

equivalent artificial drugs), named "Pedra hume de kaá".

Phytochemical analysis of the Myrcia extracts reported kinds of flavanone glucosides

(myrciacitrins) and acetophenone glucosides (myrciaphenones), and inhibitory

57

activities on aldose reductase and alpha-glucosidase.

Cinnamon

At least two studies have shown that cinnamon can act significantly

reducing some effects of diabetes. One study on people used fine ground cinnamon

(Cinnamomum cassia) for oral consumption. Another study used an extract (MHCP)

on laboratory rats. The study on people published in 2003 conducted in the Department

of Human Nutrition, NWFP Agricultural University, Peshawar, Pakistan concluded

"that the inclusion of cinnamon in the diet of people with type 2 diabetes will reduce

risk factors associated with diabetes and cardiovascular disorders."The study on

laboratory rats at Department of Biochemistry, Biophysics and Molecular Biology,

Iowa State University published in 2001 used purified hydroxychalcone (MHCP) from

cinnamon. Part of the study's conclusion stated that "the MHCP is fully capable of

mimicking insulin" and recommended further studies.The Food and Drug

Administration has not yet evaluated the use of cinnamon for the management o f

diabetes.

Ayurvedic Treatment for Diabetes

According to ayurveda, diabetes is a metabolic kapha type of disorder

in which diminished functioning of agni leads to a tendency toward high blood sugar.

(Ayurveda recognizes 24 forms of the disorder commonly classified under Prameha - 4

are due to Vata dosha, 6 are due to Pitta dosha, and 10 are caused by Kapha dosha. The

main causes of these disorders are fat, urine, and Kapha buildups due to foods, liquids,

lifestyle and others.) Ayurvedic practitioners also use several herbal preparations for

diabetics. Exercise is another cornerstone of ayurvedic treatment of diabetes.

1. Juice of bitter melon or bitter gourd (Momordica dioica, Roxb., Karela), or Rose

apple (Eugenia Jambos, Linn., Jambu) or two tender leaves of Bilva (Aegle

Marmelos, Corr., Bael fruit) and Neem (Melia azadirachta, Ravipriya, or Indian Lilac)

may be taken on empty stomach daily.

Juice of Jambu should be taken in an ounce quantity twice daily, and that of Karela in

1-1/2 ounce dose daily.

Shilajit (Swertia Decussata Nimmo.) is another useful medicine (250 mg as a single

dose) should be taken, twice daily with juice of stone apple.

2. Use turmeric. Fill some 00-size capsules with turmeric, and take 2 capsules 3 times

a day, a few minutes before meals. Continue this program for up to a month, and then

reevaluate your condition. Clinical observation suggests that a person who is insulin

dependent will experience a markedly diminished requirement for insulin; the

diabetes can often be brought under control.

3. Take 1/2 teaspoon of ground bay leaf and 1/2 teaspoon turmeric, mixed in

58

1 tablespoon aloe vera gel. Take the mixture twice a day before lunch and dinner.

4. Take twice daily, with powder of rose apple stones (powder of Jambu or Jamun-ki-

Guthali).

5. Include decoctions of triphala, fenugreek, musta, arjuna, sandalwood, lodhra, ajwan,

gokshura, vidanga, guduchi, haritaki, and chitrak. These may be taken with a small

amount of ghee. Gudmar and shilajit are excellent.

6. Amalaki Churna (500mg), Haldi Powder (Turmeric Powder) 500mg and

Naag Bhasma (125mg) should be taken with honey, twice daily ( A 12- hourly

dose ).

Anti-diabetic spray

Diabetics, who are used to insulin shots, have a painless option -

a spray which can be delivered through the inner lining of the mouth. And the

pleasure of chewing an insulin bubble gum is not far off for them. Shreya Life

Sciences India, launched the Oral-Recosulin spray in. the product would be the

world's first recombinant DNA human insulin buccal spray effective against Type

I and Type II diabetes. Each pack of Oral-Recosulin will have 80 puffs equivalent

to per unit of injection. Each vial of insulin available in the market now consists

of 300 units of injection priced at a range of Rs 125 to Rs 1,000 but oral -

Recosulin will come at an approximate price of Rs 2,200 for a pack of two vials.

The drug has been developed by US-based Generex Biotechnology Corporation.

Shreya has entered into a product licensing and distribution agreement with

Generex to market the product in India. The new technology delivers insulin

through Buccal Mucosa directly to the vascular system and, thus, does not enter

the lungs. Hence, there would not be any side effects, Dr Jaime Davidson,

endocrinologist and medical director of Generex, said.

The next non- injectable insulin product of Generex would be 'metcontrol', a chewing

gum, Abajian said.

Yoga

Yogic exercises can help with diabetes. When practiced as part of a

daily yoga routine of breathing exercises, meditation and poses, these exercises

enhance digestion and help the pancreas and liver function more normally,

regulating blood sugar levels.

Yoga Asana Useful for Diabetes:

Sun Salutation

Peacock pose

Locust pose

Leg lift

Chest knee pose

59

Exercise and Diabetes

There are several important benefits of exercise.

Exercise helps reduce blood glucose levels and makes insulin more effective.

Exercise helps people maintain their lower weight.

Exercise is believed to improve insulin's sensitivity (its ability to work).

Exercise reduces the dosage requirement or the need for blood- glucose

medications.

Exercise reduces the risk of cardiovascular disorder.

Many physiotherapists recommend that exercise daily whether you are suffering

from diabetes or not. It will help prevent the disorder or delay the onset if you don't

have diabetes yet. Exercise alone can't control blood-sugar levels, except in rare

cases. Some people have the mistaken notion that as long as they are exercising

vigorously and regularly, they can eat as much of anything they want. This just isn't

true. Exercise won't control blood glucose, although it does influence it. A sound

meal plan forms the cornerstone of all treatment for type-II diabetes. Everything

else must build on that sound base.

60

All about Insulin

The failure to make insulin or insufficiency of insulin is termed as

Diabetes mellitus. Insulin is a natural hormone which controls the level of the sugar

glucose in the blood. Insulin allows cells to use glucose for energy. Cells cannot

utilize glucose without insulin. Excess glucose builds up in the bloodstream,

increasing the risk of diabetes. Glucose is the body's primary source of fuel. Insulin

enables the body cells to take glucose from the bloodstream. The cells might use

glucose for production of energy if required, or it is sent to the liver to preserve it, in

the form of glycogen.

Functions of Insulin

In addition to its role of regulating glucose metabolism, insulin also

Stimulates lipogenesis

Diminishes lipolysis

Increases amino acid transport into cells

Modulates transcription

Altering the cell content of numerous mRNAs

Stimulates growth

DNA synthesis Cell

replication

Structure of Insulin

Insulin is composed of 2 peptide chains i.e. A chain and B

chain. Both the chains are linked together by two disulfide bonds, and one disulfide

is formed within the A chain. In most species, the A chain consists of 21 amino

acids and the B chain of 30 amino acids that means it is composed of 51 amino

acids in two peptide chains (A and B). The three-dimensional structure of insulin

molecule (insulin monomer) exists in two main conformations. These differ in the

extent of helix in the B chain due to phenol or its derivatives.

61

Insulin Synthesis

Insulin is synthesized as a preprohormone in the beta cells of the islets of

Langerhans. Its signal peptide is removed in the cisternae of the endoplasmic reticulum

and then packaged into secretory vesicles in the Golgi. It is folded in its native

structure and locked in this conformation by, the formation of 2 disulfide bonds.

Insulin resistance

Insulin resistance comes in picture when the total amount of insulin

produced by the body (pancreas), proves to be insufficient to maintain normal blood

glucose level. Extra insulin may need to break down glucose in order to release

energy. In about 1/3 of the cases blood cells resist to even high level of insulin.

Insulin resistance is mostly associated with high Triglycerides and low HDL,

hypertension, cardiovascular disorder and other such abnormalities. It is in these

abnormalities that we find the insulin resistance syndrome. Few people sometimes

suffer from various symptoms and conditions. It is thus believed that diabetes and

other problems go hand in hand.

Types of Insulin

There are more than 20 types of insulin products available in four

basic forms, each with a different time of onset and duration of action. The decision

as to which insulin to choose is based on an individual's lifestyle, blood sugar level

and a physician's preference and experience. Criterions to be considered in choosing

insulin are:

Onset:- how soon it starts working. Peak

time:- when it works the hardest. Duration:-

how long it lasts in the body.

Insulin Regimens

Insulin regimen is the way that your insulin injections are organized

throughout the day. Type1 diabetics need more than one injection per day and use

more than one type of insulin. The combination of insulins and the number of times

you take your injections, frame your insulin regimen. There are numerous types of

insulin regimens. Ideally, you will develop an individualized regimen that fits in with

your life style.

Diabetes Insulin Classification

There are five different types of insulins ranging from short to

long acting. Some insulins are clear in appearance, while others are cloudy. Diabetics

62

need varying amounts of both short and long acting insulin as everyone is different

and will respond differently to the insulin they take. Let‘s see the classification of

different types of insulin.

Rapid onset-

fast acting insulin: It is fast acting so starts working within one to 20

minutes. It is clear in appearance and its peak time is about one hour later and lasts for

three to five hours. When you inject rapid onset-fast acting type of insulin, you must

eat immediately after you inject. The two rapid onset-fast acting insulin types currently

available are:

Novo Rapid (Insulin Aspart)

Humalog (Lispro)

Short acting insulin: It looks clear and begins to lower blood glucose levels within 30

minutes, so you need to take your injection half an hour before eating. Short acting

insulin has peak effect of four hours and works for about six hours. Short acting insulin

types, currently available include:

Actrapid

Humulin

Hypurin Neutral (bovine - highly purified beef insulin)

Intermediate acting insulin:- Intermediate acting insulin looks cloudy. They have

either protamine or zinc added to delay their action. This insulin

starts to show its effect about 90 minutes after you inject, peak at 4 to 12 hours and

lasts for 16 to 24hours.

Intermediate acting insulins presently available with protamine:

Protaphane

Humulin NPH

Hypurin Isophane (bovine)

Mixed insulin: Mixed insulin is cloudy in appearance. It is a combination of either a

rapid onset- fast acting or a short acting insulin and intermediate acting insulin.

Advantage of it is that, two types of insulin can be given in one injection. When it

shows 30/70 then it means 30% of short acting is mixed with 70%of intermediate

acting insulin.

The mixed insulins currently available include:

NovoMix30

Humalog Mix 25

Mixtard 30/70

Mixtard 20/80

63

Long acting insulin: There are two kinds of long acting insulin available in market,

both with clear appearance.

Lantus (Glargine) - It has no peak period as it works constantly when released

into your bloodstream at a relatively constant rate. (full 24 hours)

Levemir (Detemir) - It has a relatively flat action, can last up to 24

hours and may be given once or twice during the day.

Diabetes Prevention

Prevention is proven to be one of the most effective and powerful

methods to fight diabetes. More than 50% of diabetes is caused due to inappropriate

lifestyle. Regulating lifestyle can prove to be advantageous in downfall of probability

of contracting diabetes in one‘s life. Loss of weight not only helps in fitness but also

in control of blood sugar levels. Losing 10% of initial body weight and regular

exercise can immensely reduce the risk of diabetes. Physical activities play a key role

in reducing the body weight and on the other also the extra blood sugar is broken

down. It also helps to uphold the blood sugar in the normal range. You are more

liable to diabetes if you are overweight (may also lead to obesity), are having genetic

or hierarchal means of predisposition along with proper physical activity.

Food choices: Foodstuffs containing low glycemic carbohydrates, proteins or fats can

initially help to lose body weight and maintain dancing blood sugar level. Prefer

healthy foods which are low in fats and calories such as lean fish, lean chicken, turkey

and fruits and vegetables. Go slow on fast and fried foodstuffs for prevention of

diabetes. Avoid processed carbohydrates as much as possible. Try to increase high-

protein food in your diet. And reduce eating refined flour i.e. white flour, bleached

flour, treated flour and other kind of white flour.

The Fundamentals to prevent diabetes: Diabetes can be prevented by good production

of the insulin and keeping the body fat percent low. Insulin and fats helps to maintain

body weight and control sugar level. Consumption of meals to a small fraction instead

of heavy food also helps to control diabetes. Also avoid eating carbohydrates few

hours before you go to sleep. Taking in high-protein breakfast and 5 or 6 small meals

a day also helps you to maintain the body weight. This will also help to control excess

consumption of fats and carbohydrates.

Diabetes Complications:-

Once we have crossed the reversible stage of prediabetes and enter

diabetes stage, certain changes start developing in our body. These changes occur due

to high blood sugar level with instability in the hormones as well as blood vessels and

nerves. When these changes become permanent in the body it develops into serious

Diabetes Complications and body indicates these changes by steady symptoms.

64

Symptoms of the Diabetes Complications

Diabetic retinopathy shows symptoms of pain in the eyes and may even

result in loss of vision.

Renal (kidney) disorder shows symptoms of swelling (edema) in the feet

and legs. It then passes over total body and as the disorder progresses, blood

pressure also increases.

Tingling, burning, numbness, tightness, shooting or stabbing pain in the

hands, feet or other parts of your body, especially at night. Digestive

problems also occur if, the nerves controlling internal organs get damaged

(autonomic neuropathy).

You may have scanty or profuse sweating, difficulty of sensing when your

bladder is full, when there is a low blood sugar, increased sexual problems,

weakness, dizziness, and fainting.

Chest pain (angina) or shortness of breath dizziness or light headache, shoulder

or stomach pain, fast heartbeat. You might not show any symptoms until

having a heart attack or stroke.

When alarming symptoms given by the body are ignored and the same status is

maintained, it starts damaging body organs, such as heart, kidney, eye, feet, and skin.

The physiology for each and every affected organ is explained one by one.

Diabetes Treatment and Insulin Problems

There are many things which can affect how the insulin is absorbed from the

injection site into the bloodstream.

It includes:

Mode of administration

Selecting the 'right' dose and timing

Selecting a suitable insulin preparation (typically on 'speed of onset and

duration of action' grounds)

Adjusting dosage and timing to fit food intake timing, amounts, and types

Adjusting dosage and timing in accordance with exercise undertaken

Adjusting dosage, type and timing according to other conditions like stress,

illness etc

The dosage is non-physiological in that a subcutaneous bolus dose of insulin

alone is administered instead of combination of insulin

It is dangerous in case of mistake (Hypoglycemia or Hyperglycemia) Once

open insulin may be preserved for 30 days at temperature less

than 86 °F.

Diabetes Control

65

Whether your treatment consists of diet alone, diet and tablets or

diet and insulin, you need regular blood tests to keep a check on your blood sugar.

Urine sugar test is not a reliable indicator of diabetes control. When blood glucose

remains higher than 200mg/dl for 8-10 weeks, the concentration of glycosylated

hemoglobin (HbA1c) arises. A (HbA1c) measurement therefore reflects the blood

glucose control over a preceding 2- 3 months period, while the estimates of blood

glucose indicate the glucose value at the time of blood test. HbA1c values between

6-7% indicate very good control on diabetes. You should aim at keeping your blood

glucose in the normal range i.e. between 90-130 mg/dl while fasting and less than

180 mg/dl after meals and HbA1c around 7%. Frequent tests for blood glucose are

necessary when starting treatment with insulin.

If you are doing capillary blood glucose test using a hand held

glucometer, do not squeeze the finger to bring out a sample after you have picked.

This invariably gives a low glucose value. Ask your diabetes nurse for a

demonstration of capillary blood glucose test. Urine test for sugar is not reliable

indicator of diabetes control. Although spillage of sugar in urine occurs when the

blood glucose exceeds 180 mg/dl in the majority of healthy persons, this is not always

so in a patient with diabetes. Most patients with diabetes of many years acquire an

increase in the renal threshold for glucose (capacity to prevent spillage of glucose into

urine). Hence urine test for glucose is not helpful for assessing control of diabetes. In

the presence of urinary infections, the bacteria eats up the sugar present in urine,

thereby making urine test for sugar unreliable.

Trends and Recent Developments:

WHO projects that diabetes death will increase by more than 50% in

the next 10 years without urgent action. Most notably, diabetes-associated deaths

are projected to increase by over 80% in upper-middle income countries between

2006 and 2015. The global diabetes market is projected to have several crucial

product launches by 2011 including Pfizer‘s inhaled- insulin Exubera, with

forecasted sales of over US $2 billion in 2011. Further upcoming classes of

OADs (oral ant diabetics) are also anticipated to push up sales, such as DPP-IV

inhibitors and GLP-1 agonists, making it possible for pharmaceutical companies

to extend their revenue streams. There are also three key new OAD classes.

PPAR agonists, GLP-1 agonists/DPP IV inhibitors, and amlinomimetic agents.

Sales are also forecast to be high for GLP-1 agonist ‗Exenatide LAR‘ and the

DPP-IV inhibitor ‗Galvus‘ at $2.9B and $1.3B, respectively. Inhaled insulin is

expected to play an important role in expanding the insulin market. However,

their success will depend on whether they deliver their promise of increased

convenience and compliance.

66

Indian Pharma Industry Scenario

Global Pharmaceutical Industry grew by 7% to $680 billion in 2007-

08. Branded prescription drugs had the largest share of the market i.e. in 2007 it was

worth $525.1 billion. The second largest segment, generic prescription drugs, was worth

$78.5 billion in 2007 whereas the OTC segment was worth over $90.0 billion in 2007.

Breakup of global pharma market ($ bn)

Branded prescription drug to contribute ~76% of the global pharma

market. India, amongst the fastest growing pharma market. Formulations, to grow at a

robust CAGR going forward OTC 90, Branded prescription 525.5, Generic prescription

78.5 India‘s pharmaceutical industry plays a vital role in the healthcare area of the

nation. With the implementation of product patent from the year 2005, there was a

tough Competition for the global market share. Pharmaceutical companies have to

focus more intensively on R&D activity to survive the competition. The Indian pharma

industry ranks Fourth in volume terms and thirteenth in value terms worldwide. The

countries Pharmaceutical market is at US$ 6 billion and is expected to cross US$ 20

billion mark in 2015.

Formulations

Formulations are the end product, which uses bulk drugs. The Indian

formulations Segment has grown at a CAGR of 13.44 percent from 2002- 2007

and is expected to grow at a CAGR of 12.95 percent over 2007-2011.

67

Domestic Formulation Market

Therapeutic

Category

Sales (Crores) March 2008

value growth

% of sales

Ant diabetic 1600 27.2 6%

Anti- infective 5730 15.2 20%

Cardiac 3480 23.4 12%

Derma 1750 12.6 6%

Gastrointestinal 3500 14.1 13%

Gynaec 1810 18.9 6%

Neuro 1760 16.6 6%

Pain 2840 8.2 10%

Respiratory 2880 11.6 10%

Vitamins 2630 9.8 9%

Total 27980 14.8 100%

Lifestyle segment

Lifestyle segment which includes anti-diabetic, cardiac and gastro-

intestinal have registered a growth of more than 20% during the year. The total

lifestyle segment contributed to around 31% in the therapeutic category as on March

2008. In 2015, the anti-diabetic market in India is expected to grow at a CAGR of

17.02% to Rs.84 billion and the cardiac market is expected to grow at 12.40% to

Rs.143 billion in sales. India has the world‘s largest diabetic population, constituting

20 percent of the world‘s diabetic population.

Indian Anti-diabetic Market

India, which is home to the largest diabetic population in the

world, has recorded a 17% rise in the anti-diabetic drug segment. The segment

recorded sales of Rs 1,695 crore in the 12 months to August 2008 compared to Rs

1,402 crore in the corresponding period last year, according to ORG IMS data.

The segment‘s contribution to the Indian pharmaceutical market as of

June 2008 was also higher at 5.1% compared to 4.6% in the corresponding period up

to June 2007. With changing consumption patterns and more sedentary lifestyles in

68

India, industry sources expect this to at least double in the coming year. A study by

Decision Resources, a research-based consulting organization, shows that the

prevalence of type 2 diabetes in India is among the highest in the world with more than

28 million cases in 2007. The prevalence of type 2 diabetes is expected to grow more

rapidly in India than in any other nation, climbing to more than 60 million cases by

2017. Type 2 diabetes is the most common form of diabetes. In type 2 diabetes, either

the body does not produce enough insulin or the cells ignore the insulin.

―WHO‘s Burden of Disorder report states that diabetes is going to

grow by 40% in developed countries, but by 170% in developing countries. Apart from

this rise, there are so many undiagnosed people,‖ said International Diabetes

Federation vice-president SM Sadikot. A study by Mr Sadikot has shown that by 2030,

the number of rural people suffering from diabetes will equal those in urban areas.

Oral diabetic medication generated revenues of Rs 1,183 crore in the last year while

insulin posted sales of Rs 511 crore, according to an ORG-IMS report. The top players

in this segment include Abbott, USV, Sanofi Aventis, Sun Pharma, Nicholas Piramal

and Wockhardt.

The number of companies looking to enter this therapeutic area is also on

the rise. ―Lots of companies are looking at entering the chronic

illness space. With a slowing down of acute illnesses in larger cities and towns and

the change in lifestyles, companies who have a presence in anti- infectives are also

entering the anti-diabetic space,‖ said Alok Dalal, analyst with Religare.

Trying to break into the chronic illness segment is easier when compared to CNS

(central nervous system) segment, he added. Piramal‘s shift in focus from acute to

chronic is a case in point. ―Lots of companies are working on molecules for diabetes

and we should see a new molecule out in a couple of years. As far as MNCs go, GSK

will probably be the leader in launching a molecule.

Decision Resources‘ report forecasts that the Indian type 2

diabetes drug market will double from $504 million in 2007 to more than $1.1

billion by 2012. This potential has not gone unnoticed by the industry and Indian

companies are not the only ones looking at this segment as a lucrative market.

European companies are also looking at entering this segment either through

collaborations or formal dialogue between governments. The UK is the first to have

taken a step in this direction. ―There are 180 million diabetic people in the world

today and India accounts for 27% of that. We plan on working with different

organizations and countries to combat this, India being one of them,‖ said Ann

Keen, UK under secretary of state for health, at a diabetes conference in Mumbai

last three month before. Sujay Shetty, associate director at PricewaterhouseCoopers,

said, ―Chronic disorders like diabetes are going to be a big market going forward.

This segment‘s contribution to the overall pharmaceutical market is going to

increase.

69

Market Metrics

Diabetes is estimated to account for 23% of annual pharmacy store

revenues in the U.S. The largest diabetes care market by a wide margin is the United

States, which, at close to $7 billion in 2002, was well over five times larger than

second-ranked Japan. Again, the World Health Organization (WHO) estimates that

almost 180 million people worldwide are afflicted with diabetes. This number is

expected to more than double by 2030. In 2005, an estimated 1.1 million people died

from Type 1 diabetes. Almost 80% of diabetes deaths occurred in low and middle-

income countries and almost half of diabetes deaths occurred in people under the age

of 70 years. Women account for 55% of deaths associated with diabetes.

The global market fro a diabetes drug was valued at US $15 billion in

2005. Oral anti-diabetics were the chief class of drugs - $8.19 billion - and showed a

growth rate of 6.3% over 2004. Total sales for insulin products increased by 16.5% to

total global sales of $6.83 billion in 2004.

The insulin class medications dominate the anti-diabetics market, with a

37.5% share of its global sales.

The United States has the dominant share in the global diabetes market,

with 49.6% of 2005 global share in the global diabetes market, with 49.6% of 2005

global sales.

The leading 7 expanding markets of Anti-Diabetic are US, Japan,

France, Germany, Italy, Spain, and UK. These are 7 major markets of globally & the 7

emerging (expanding) Anti-Diabetic markets are India, China, Indonesia, Turkey,

Mexico, Brazil, and Russia.

Medicines Present in Market

70

A List of Oral Diabetes Medicines

Drug Category

Brand and

Generic

Name

< works it

How>How it

works

Advantages

Disadvantage s

Alpha-

glucosidase

Inhibitors

Glyset,

Precose

Blocks the

absorption of

some

carbohydrate s

in the intestine

Lowers

blood glucose

after meals,

does not cause

low blood

glucose

May cause

gas, bloating

and diarrhea.

Biguanides Glucophag

E

Helps the

body use it's

own insulin

better: muscles

use more

glucose and the

liver makes

less glucose.

Does not

cause low

blood

glucose, may

help with

weight

loss and can

improve

blood lipids

(fats).

Can't take if

you drink

alcohol

excessively.

Can cause

nausea and

diarrhea

when started.

Meglitinides Prandin Reduces

blood

glucose

Rapidly

absorbed by

the body.

Can cause

blood glucose

to get too

71

levels by

stimulating

insulin release

form the

pancreas.

Can be used

alone or

with

metformin.

low.

Thiazolidinedio

Nes

Actos,

Avandia

Works to

decrease

insulin

resistance

and improves

the muscle's

ability to use

insulin. Does

not make more

insulin.

>

Cannot

cause blood

glucose to get

too low if it is

the only

diabetes pill

taken.

Can cause

liver

problems.

Some birth

control pills

may not

work.

Sulfonylureas Diabeta,

Glucotrol

XL

Amaryl,

Micronase,

Glynase

Generic:

Glyburide,

Glipizide

Lowers blood

glucose by

helping the

pancreas

produce more

insulin.

These are

2nd

generation

drugs with

fewer side

effects than

older

sulfonylurea

s.

Can cause

blood glucose

to get too

low.

72

Recombinant Brand Human Insulin Anti-diabetic Drugs Present in Indian Market

Recombinant Brand Human Company Year of Launch

Insulin

Huminsulin Eli Lilly and 1982

Company India

Insugen Biocon 2004

NovoMix30 and NovoRapid Novo Nordisk 2003

Recosulin Shreya Life Sciences 2004

Wosulin Wockhardt 2003

73

Major Players of Anti-Diabetic In India

Novo Nordisk India (Diabetes care leader)

Novo Nordisk has a 60% market share in the Rs 375-crore domestic

insulin market. Novo Nordisk India is the Indian subsidiary of Novo Nordisk, a

focused healthcare company and a world leader in diabetes care. The company has

the broadest diabetes product portfolio in the industry, including the most advanced

products within the area of insulin delivery systems. Novo Nordisk has a leading

position in areas such as haemostasis management, growth hormone therapy and

hormone replacement therapy. It manufactures and markets pharmaceutical products

and services that make a significant difference to patients, the medical profession and

society.

Novo Nordisk India employs over 600 persons currently. It plans to triple its staff

strength in four years. The company has a 60 percent market share in the Rs 375-crore

domestic insulin market In May 2006; it launched Levemir, a basal insulin analogue

that works on the mechanism of prolonging action. The insulin is delivered to the

patient through a pen like mechanism.

Novo Nordisk India's FlexPen is priced at Rs 930 for a 300 ml pen, on

par with other analogues in the market. Novo Nordisk India has increased its sales

force that covers 30,000 doctors manning diabetic clinics in India to recommend the

use of Levemir. It imports Levemir from Denmark. The company expects to capture

one-fourth of India's basal insulin market this year. Novo Nordisk India has an

exclusive agreement with Torrent Pharma for the manufacture of insulin formulations.

Torrent Pharma has been manufacturing insulin for Novo Nordisk's India requirement

for more than 15 years now. Besides marketing a portfolio of therapeutics products

like NovoPen 3, Novolet and Flexpen, it has in its basket products like NovoMix 30

(premixed insulin analogue) and NovoRapid (rapid acting insulin analogue). It has a

distributorship alliance with Abbot India. A recent study has shown Novo Nordisk's

FlexPen's superiority over SoloStar, from Sanofi-Aventis. FlexPen is more accurate

when delivering insulin than other pens like the newly launched prefilled device,

SoloStar, from Sanofi-Aventis, which FlexPen significantly outperformed in both

studies, according to a Novo Nordisk company release. The two studies were lead by

Prof Andreas Pfützner from IKFE, Institute for Clinical Research and Development in

Germany,and Dr Toshinari Asakura from the Niigata University of Pharmacy and

Applied Life Sciences in Japan. The German study was published in the May 2008

issue of Diabetes Science and Technology.

General Information

Headquarter: Denmark

International: International Production facilities in six Countries. Affiliates or

offices in 81 countries. Workforce: More than 27,068 employees (December 2008).

Approximately 48% of employees are locatedin Denmark (13,050) and 52% in the rest

of the

74

World (North America: 3,727, Japan & Oceania:

1,033, International Operations: 5,587

Europe: 3,671).

17% within research and development

30% in production and production

34% in international sales and marketing

19% in administration

Product areas : Diabetes care

Growth hormone therapy : Haemostasis management (NovoSeven® )

Hormone replacement therapy (HRT)

Sales : 45,5

75

Eli Lilly

Eli Lilly launched Byetta, a new class of drug for Type B diabetics

and has plans to launch new products in the coming years.

Eli Lilly and Company (India) is a 100 percent subsidiary of the US pharmaceutical

major, Eli Lilly and Company. The company first came to India in 1993 as a JV with

Ranbaxy. It became a wholly owned subsidiary in 2001 when Lilly bought the 50

percent stake held by Ranbaxy and since then the company has established a

formidable presence in cardiology, diabetes and oncology amongst other therapeutic

segments. Lilly India has five products from the biotechnology stable. All injectibles,

they are human insulin (including human insulin analogs), human growth hormone,

Teriparatide (Forteo), Drotrecogin Alfa (Xigris) and Exenatide (Byetta). Overall,

diabetes care product range contributes roughly 60 percent of the Lilly India revenue.

In the biotech category, the company grew an impressive 20 percent in 2007 clocking

revenue of Rs 137 crore compared to Rs 114 crore in 2006. The company's recent

product launches include Byetta that was introduced in October 2007. The drug

belongs to a new category called "incretin mimetics" and is a unique treatment option

for Type 2 diabetics, more specifically for patients who have maxed out on the OHA's

(oral hypoglycemic agents). According to Sandeep Gupta, CMD, Lilly, "Byetta is a

first-in-class product. These are early days; however within 3-4 months from its

launch, nearly 1000 patients have been put on the therapy across India." Forteo, Lilly's

novel therapy that 'rebuilds' bones and is used for treating women with osteoporosis,

registered a whopping growth of almost 100 percent in 2007 as compared to the

previous year.

Lilly India recently tied up with an Ahmedabad-based Contract Sales

Organization (CSO), PharmaLink, to further enhance its reach in large towns while

maintaining adequate coverage in smaller markets. The company also divested its

premium antibiotic brand, Distaclor. This was done with a view to augment company

focus on its range of new products. Also in a global deal, the company entered into a

unique drug development agreement with Mumbai-based Nicholas Piramal India Ltd

(NPIL) in 2007. Under this partnership, Lilly has outlicensed a molecule for 'metabolic

disorder' o NPIL with an arrangement to do research till phase III and if the product is

found to show the desired potential.

Wockhardt

Wockhardt is a technology-driven global pharmaceutical and

biotechnology major with an innovative multi-disciplinary research and development

programme. It has 5 research centres and 15 world-class manufacturing plants dotting

various countries and continents that are compliant to international regulatory

standards such as the US FDA, MHRA or other global regulatory bodies. It has end-

to-end integrated capabilities for its products, starting with manufacture of the oral and

sterile API‘s, the dosage forms and marketing through its wholly owned subsidiary in

the US. Wockhardt has a global footprint including the USA, UK, Ireland, France, and

76

Germany with a multi-ethnic workforce from 14 different nationalities A

Pharmaceutical and biotechnology major Wockhardt has announced the launch of its

new insulin (Glaritus), a recombinant long acting human insulin analogue. Wockhardt

is only the 1st company in the world after the innovator to launch this new insulin

(Glaritus) that works slowly for over 24 hours. Currently, the worldwide market for

this insulin (Glargine) is $2 billion. As per ORG IMS, the current market for

analogues in India is Rs. 120 crores growing at 37% per annum. This new insulin

(Glaritus) has been successfully clinically tested on 300 diabetic patients for safety &

efficacy parameters and is approved by the Drug Controller General of India. The

launch of Glaritus is a significant landmark for India, which has one of the highest

diabetes affected populations in the world. The advantage of Glaritus is that it is a

once daily dose and provides basal glucose control over 24 hours. Glaritus can hence

be easily combined with other oral medications of diabetes for effective blood glucose

control. Moreover, Glaritus is meal independent, peakless insulin, which reduces

incidences of hypoglycemia significantly. All this translates into more compliance to

insulin therapy, improved blood glucose control and therefore slower progression of

diabetes related complications. Glaritus is available to the patients as reusable and

disposable pen delivery devices. Wockhardt is one of the few select companies in the

world to patent the technology of pen based insulin delivery devices, which is one of

the most preferred modes of insulin injection across the globe today. Wockhardt

insulin pen devices are ISO 11608 approved and have won the IndiaStar, AsiaStar and

the WorldStar awards for excellence in packaging technology for 2008.

Glaritus is manufactured at Wockhardt‘s state-of-the-art biotech park in Aurangabad.

Wockhardt, over the recent years has built a comprehensive diabetes

management portfolio that includes insulins, oral medications, blood glucose monitors

& diabetes nutrition products.

Aventis Pharma

Aventis has carved a niche for itself in the insulin market. Aventis Pharma

clocked total biotech revenue sales of Rs 105 crore in 2007- 2008 as against the sales of

Rs 119.65 crore in 2006-2007. Targeted therapeutic areas for Aventis Pharma include

oncology, cardiovascular disorder/thrombosis, central nervous system, metabolic

disorders and the prevention and treatment of infectious disorders. It has also been

leading in the anti-rabies vaccines market. It markets anti-rabies vaccines under the

brand Rabipur which figures among the top 100 brands of the retail market. Another

leading brand which contributed to the growth this fiscal was Lantus. The world's first

once daily insulin glargine, Lantus, had an impressive growth of 64 percent in the year.

It is now the fifth largest insulin in India and has a market share of 6.1 percent in its

category. Lantus is expected to register an 80 percent growth in the current fiscal. Also

in a continuous effort in the field of diabetes, a world class Autopen 24 in a starter pack

77

in three cartridges was launched. Amaryl, which is an oral anti- diabetic, had a 4.4

percent share in the oral anti-diabetic market.

Aventis conducted a large observational study in 2007, with around

10,000 patients evaluating effect of the change of the insulin therapy in type 2

diabetes patients whose blood sugar was not under control with the existing insulin

therapy. The study involved 800 doctors. Also another observational study was

implemented with about 200 doctors to observe the management of myocardinal

infarction and usage of anti- thrombotics. Another observation study with Cardace was

implemented in which management of patients who are at high risk of cardiovascular

events in real life settings was evaluated.

Biocon

The total revenues of Biocon, one of India's premier biotechnology

companies, for fiscal 2007-08 increased 19 percent to Rs l,090 crore, up from Rs 990

crore in the previous year, and net profit increased by 3 percent to Rs 225 crore. The

consolidated revenue (excluding enzymes) increased by 19 percent from Rs 881 to Rs

1,044 crore this fiscal. Impressive growth in research services helped Biocon post a

fourth quarter profit of Rs 62.03 crore, a growth of 31.16 percent from Rs 47.29 crore

in the same quarter last year. The company's net sales in the quarter that ended March

31, however, declined 5.92 percent to Rs 219.75 crore and total income fell by 1.09

percent to Rs 236.71 crore.

Biocon's profit growth has been maintained at the consolidated level

despite the divestment of the enzymes business, currency appreciation and increased

depreciation. The company has a strong balance sheet with high reserves and Rs 193

crore in net Established in 1978, Biocon and its two subsidiary companies, Syngene

International and Clinigene International form a fully integrated biotechnology

enterprise, specializing in biopharmaceuticals, custom research and clinical research.

With successful initiatives in clinical development, bioprocessing and global

marketing, Biocon delivers products and solutions to partners and customers across the

globe. Many of these products have USFDA and EMEA acceptance. Biocon launched

the world's first recombinant human insulin, Insugen in November 2004 using Pichia

expression and India's first indigenously produced monoclonal antibody BIOMAb-

EGFR. Biocon has decided to split up its cardio-diabetes group by launching a stand-

alone cardiology division. This new division is being launched to focus on brand

building for its flagship statin-based product Statix as well as other products viz.

Telmisat, Eptifibatide and its recombinant streptokinase product Myokinase. This

division is envisaged to have an all-India presence through a 250+ strong field force.

78

Shreya Life Sciences

Shreya Life Sciences Pvt Ltd of Mumbai has introduced world's first

buccal insulin spray under the brand name Oral-Recosulin. Shreya Life Sciences has

achieved this major success with the help of US-based Generex Biotechnology

Corporation. The insulin spray will be helpful in treating type-1 and type-2

diabetes patients. Generex Biotechnology has used its special technology to

develop his spray insulin. According to chairman and managing director of Shreya

Life Sciences, Sujit Kumar Singh, each pack of Oral-Recosulin will be available at a

cost of Rs 2200. Oral-Recosulin regulates prandial glucose rapidly within five to 10

minutes of intake. The medicine then last for duration of 120 to 150 minutes. The

major advantage of this insulin spray is that the diabetes patients will no longer

need to take injections. Apart from it, the spray operates very rapidly once consumed

by the patients. According to a company source of Shreya Life Sciences, spray

insulin will provide simple solution for worldwide diabetes problem Generex

Biotechnology Corporation will market the product in US market under the name o f

Oral-lyn. Under deal, Shreya Life Sciences will provide the insulin crystals while

the buccal device will be supplied by Generex Biotechnology Corporation.

USV LTD.

USV is a leading health care company with the following areas of

focus: Branded Generics, Active Pharmaceutical Ingredients (APIs) and Bio-

similar. Sixty-six percent of our business is contributed by the India operations and

the rest by export of APIs and Branded Generics. By Rx (prescription), USV is

rank No. 1 in Diabetes and Cardiovascular disorder segments. USV have an active

in- licensing program to enhance there product portfolio. The strategy is to

introduce innovative specialized products while retaining a focus on brand

building. USV lead the oral anti-diabetic segment in India in terms of value as well

as prescriptions. USV have maintained a leadership position in this segment for

almost two decades. 34% of sales are contributed by the anti-diabetic portfolio,

which includes insulin.

USV lead in the cardiovascular disorder segment in terms of prescription

generation. In terms of value, USV rank amongst the first 10 companies in India.

The cardiology portfolio contributes 30% to our sales.

Presence in Respiratory, Nutritionals, Orthopaedics and Gynaecology segments

is attributed to innovative products through partnerships with companies from

Europe and USA.

USV completed the financial year 2007-08, registering sales of

Rs.7319 million (USD 181 million). USV have a 2759 member work force that have

the opportunity to learn and develop their knowledge in an open, encouraging, team

environment. USV aim at being a reliable healthcare partner to all those they interact

with - whether customer, collaborator, in- license partner, doctor or patient

79

Market Research on Huminsulin-R:-

Now a days Diabetes is a common disorder in every country.

That‘s the reason the anti-diabetic market is expanding or increasing day by day.

Now days Insulin is easily available in every country. Old aged people are suffered

more towards the diabetes. Day by day the number of patient is increasing. To seeing

the opportunity every company launching the anti- diabetic drug.

In India Eli Lilly have major market share in anti-diabetic market. They

have 60% market share, followed the Eli Lilly, Novo Nordisk India is the major

player in India. The major brand of Eli Lilly is Huminsulin (r) U100

Huminsulin-R:-

How does Huminsulin work? What will it do for me?

Huminsulin-R from Eli Lilly contains Insulin. Insulin is a hormone that is central to

regulating energy and glucose metabolism in the body. Insulin causes cells in the liver,

muscle, and fat tissue to take up glucose from the blood, storing it as glycogen in the

liver and muscle.

Insulin stops the use of fat as an energy source. When insulin is absent, glucose is not

taken up by body cells and the body begins to use fat as an energy source, for example,

by transfer of lipids from adipose tissue to the liver for mobilization as an energy source.

As its level is a central metabolic control mechanism, its status is also used as a control

signal to other body systems (such as amino acid uptake by body cells). In addition, it

has several other anabolic effects throughout the body.

80

How should the patient use Huminsulin-R?

Your doctor or diabetes educator will determine the appropriate dose for you

according to various lifestyle factors and the blood glucose values obtained while

monitoring your blood glucose.

Your dose of insulin should be injected subcutaneously (under the skin) exactly

as instructed by your doctor or diabetes educator. Each 1 mL of insulin contains 100

units. Insulin is injected under the skin once or twice daily. In addition to insulin,fast-

acting insulin is usually used to control the impact of food intake on blood glucose

levels during the day. There are many variations of insulin dosing.

Insulin should be clear and colorless. Do not use the insulin if you notice

anything unusual in the appearance of the solution, such as cloudiness, discoloration,

or clumping. It is not necessary to shake or rotate the vial before use. It should not be

mixed with any other insulin. Many things can affect the dose of a medication that a

person needs, such as body weight, other medical conditions, and other medications.

The timing of insulin with respect to your meals is crucial to keeping blood

glucose under control and preventing unwanted side effects. Do not administer a

double dose to make up for a missed one.

Store unopened bottles of insulin in the refrigerator until needed. They may

be used until the expiry date on the label. Never allow insulin to freeze. Insulin that is

currently in use may be kept at room temperature (below 30°C) for no more than 42

days and then discarded. Do not expose insulin to extremely hot temperatures or to

sunlight. Keep insulin out of the reach of children.

Forms of Huminsulin-R

Each mL contains salt-free anhydrous insulin,. Nonmedicinal ingredients:

disodium phosphate dihydrate, glycerol, metacresol, phenol, sodium chloride, zinc

acetate, and Water for Injection. The pH is adjusted by adding aqueous solutions of

hydrochloric acid or sodium hydroxide to approximately 7.4. Insulin is long-acting

that works slowly over about 24 hours. You may have to use insulin in combination

with another type of insulin or with a type of oral diabetes medicine to keep your

blood sugar under control. This medicine is available only with your doctor's

prescription, in the following dosage forms: Parenteral Injection (U.S.) Before

Using This Medicine

For Hminsulin-R, the following should be considered:

81

Allergies—

tell your doctor if you have ever had any unusual or allergic reaction to insulin

detemir. Also tell your doctor and pharmacist if you are allergic to any other

substances, such as foods, preservatives, or dyes.

Pregnancy—

the amount of insulin or insulin detemir you need changes during pregnancy. It is

especially important for your health and your baby's health that your blood sugar be

closely controlled before you become pregnant and throughout pregnancy.

Breast-feeding—

It is not known whether insulin detemir passes into human breast milk. Although

most medicines, including human insulin, pass into breast milk in small amounts, many

of them may be used safely while breast-feeding.

Mothers who are taking this medicine and who wish to breast- feed should discuss this

with their doctor.

Children—

Studies on this medicine have been done only in adult patients, and there is no specific

information comparing use of insulin in children with use in other age groups.

Older adults—this medicine has been tested in a limited number of patients

65 years of age or older and has not been shown to cause different side effects or

problems in older people than it does in younger adults.

Other medicines—

although certain medicines should not be used together at all, in other cases

two different medicines may be used together even if an

interaction might occur.

Possible Side effects with Huminsulin-R.

Many medications can cause side effects. A side effect is an unwanted

response to a medication when it is taken in normal doses. Side effects can be mild

or severe, temporary or permanent. The side effects listed below are not

experienced by everyone who takes this medication.

The following side effects have been reported by at least 1% of people taking

this medication. Many of these side effects can be managed, and some may go

away on their own over time. redness, itching, or swelling at the site of the

82

injection skin changes at injection site Stop taking the medication and seek

immediate medical attention if any of the following occur: rash or blisters all

over the body seizures symptoms of a serious allergic reaction (i.e., swelling of

face or throat, sudden sweating, vomiting, difficulty breathing, rapid heartbeat,

itchy skin rash, and dizziness) unconsciousness

What other drugs could interact with Huminsulin-R?

There may be an interaction between Huminsulin-R and any of the

following:

If you are taking any of these medications, speak with your doctor or pharmacist.

Depending on your specific circumstances, your doctor may want you to:

stop taking one of the medications,

change one of the medications to another,

change how you are taking one or both of the medications, or

Leave everything as is.

An interaction between two medications does not always mean that you must stop

taking one of them. Speak to your doctor about how any drug interactions are being managed

or should be managed. Medications other than those listed above may interact with this

medication. Tell your doctor or prescriber about all prescription, over-the- counter (non-

prescription), and herbal medications you are taking. Also tell them about any supplements

you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the

action of many medications, you should let your prescriber know if you use them.

Huminsulin-R is available as:

10 mL vials (small bottles) for use with a syringe

3 mL PenFill® cartridges*

3 mL FlexPen®

1 mL InnoLet®

* PenFill® cartridges are for use with Eli Lilly 3 mL PenFill® cartridge compatible

insulin delivery devices and NovoFine® disposable needles.

OVERDOSE

Hypoglycemia may occur as a result of an excess of insulin relative to food

intake, energy expenditure, or both. Mild episodes of hypoglycemia usually can be treated

with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed.

More severe episodes with coma, seizure, or neurologic impairment may be treated with

intramuscular/subcutaneous glucagon or concentrated intravenous glucose. After apparent

clinical recovery from hypoglycemia, continued observation and additional carbohydrate

intake may be necessary to avoid reoccurrence of hypoglycemia.

83

DATA ANALYSIS & DATA INTERPRETATION

For the collection of primary data on Huminsuli-R , I take a sample size 50 including

General physician & Diabetalogist . I ask following questions & get following data.

TOPIC: 1

The number of Diabetes patients treated by doctor in one month.

Fig no : 6 The no. of patients approach dr. in a month

The survey was perform on 50 doctors to know how much patients of diabees approach

to doctor in a month. The study showed that patients in the range of 20-30, 30-40,40-

50,50-60,60-70,70-80 approach were in percentage of 20, 23, 27, 13, 7, 10 respectively.

The communication with doctor during survey concluded that the number of patients

are increasing day by day.one of senior doctor told that initially diabetes was very less

as compared to present. it can be said that the diabetes is increasing in double ratio

specially in old age people.

Few doctors said that the main cause of diabetes is changing life style of the people.

again they gave more focus on city people who are working in night and day shift.

20-3020%

30-4023%

40-5027%

50-6013%

60-707%

70-8010%

84

TOPIC: 2

The two type of diabetes patients approach to doctors.

Fig no : 7 NIDD and IDD patient

The survey from all doctor concluded that both type of diabetes patient i.e. non- insulin

dependent diabetes mellitus(NDDM) and insulin dependent diabetes mellitus (IDM) approach

to doctor. The approach of both type of diabetes was in near about in equal percentage. But the

communication with doctor in detail provided knowledge that IDDM is more in young people

and they said that the genetic factor is the main reason for this type of diabetes and NDDM

was more in old people and for this they told that the increase in resistance of insulin receptors

with more age.

NIDD50%

IDD50%

0% 0%

85

TOPIC: 3

The survey from all doctors concluded that the diabetes is controllable

Fig no : 8 curable or controllable

After meeting to all doctors it come to known that the diabetes is only controllable i.e. only

management is possible but it can not be cure means no therapy or drug is available which can

permanently make patient free from diabetes. Patients has to regularly monitor glucose level

with glucometer like instruments. Diabetes patient also need to take lot of care in diet and the

medicine should be taken from time to time. The IDDM patient need to take regularly

subcutaneous injection of insulin. the missing of drug dose and carelessness in diet can lead to

threatening condition patient may need to hospitalized.

curable0%

controllable100%

0%0%

86

TOPIC: 4

The survey from all doctors about diabetes is a serious disorder-some said yes while

others said no and some come to conclusion that may or may not be.

Fig no :9 Survey of Diabetes whether serious disorder

About 43% doctor said that diabetes is a serious disorder .for this they give reason that it is a

chronic illness and not curable, after many years diabetes patient suffers from many other

disorder like diabetic neuropathy, many times in severe case it happens that patient some body

part is need to cut. But about 37% doctors told that it is not a serious disorder. They concluded

that if patient is well educated and has taken lot of care to maintain diabetes he can live a happy

life. the few doctors about 20% said that it can be serious or not depends totally on patient

habit, nature and life style.

YES43%

NO37%

YES & NO20%

87

TOPIC: 5

All doctors said that Herbal drug, Exercise, Yoga help to control diabetes

Fig No:10 Herbal drugs, Exercise, Yoga

The survey with all doctors help to understand that yoga, herbal drug, exercise control diabetes

and provide better health to diabetes patients. The 100% doctors have given positive response.

The regular yoga in morning has given relief to patients. The herbal formulation amla,

cinnamon, bitter gourd, jamun reduce the sugar level. The exercise like jogging etc has also

provided many benefits to patient.

Yes100%

No0%

88

TOPIC: 6

The survey from all doctors concluded that nutrition (diet) play important role to

control diabetes.

Fig No: 11 Nutrition helps in controlling Diabetes

Yes, all doctors during survey said that nutrition play important role in control of diabetes.

The proper diet maintain the sugar level at normal level. The patient who has paid lot of

attention on nurtrition needs to take less medication and they also suffers from less side

effects of drug. The diabetic neuropathy, diabetic foot ulcer are very less observed in patient

who has taken care in nutrition.

The doctor also said that the fast food is also responsoible for increasing diabetes patients. So

they advice to take proper calorie food which is needed by patients.

Yes100%

No0%

89

TOPIC: 7

The type of drugs used in type-I and type-2 diabetes mellitus.

Fig No: 12 Drugs used

The doctor said that depending on type of diabetes drug therapy also need to give different.

They said that in case of IDD mostly subcutaneous injection of insulin is preffered like insulin

lispro, insulin glargline,protmine zinc insulin. While in case of NIDD doctors like to preffered

drug as well as insulin injection. but the diabetes can be controlled mostly by taking drug

tolbutamide, chlorpropmide, metformin, sitagliptin etc. regularly.

IDD50%

NIDD50%

0%0%

90

TOPIC: 8

The most doctors said that the cost of treatment is affordable to patient is not

sufficient while few come to conclusion it may or may not be.

Fig no : 13, Cost of treatment- Affordable or Not

The statement made by doctors on whether cost of drug is affordable to patient is very

controversial. Some doctor said that it is affordable due to generic products are available in

market and lot of competitors are their for particular which are reducing the cost of drug.

While few said that the cost is not affordable for many patients and there is still need to

reduce the cost of drug. New drugs which are patented is of very high cost and it is not

affordable for many patients.while few doctors said tha t it is easy to pay the price of

diabetes drug but for many patients it is very difficult.

YES NO BOTH

91

TOIPC: 9

The side-effects of the anti-diabetic drug.

Fig No:14 Side-Effect of anti-diabetic drug

The 60% of doctor spoke that there are many side effects like vitamin deficiency, lactic

acidoisis, metallic taste, dryness of mouth, hypohlycemia.hupoglycemia side effect is very

serious it can put patient life in threatening situation. The near about 25% doctor said that there

is not that much side effect which can be neglected but there is only need to take proper dose

should be given to patiens according to situation. some said there are side effect depend on

patient physiology so few doctor said that side effect can be or not.

0

10

20

30

40

50

60

yes no both

92

TOPIC: 10

About awareness of brands Huminsulin-R

Fig No:15 Awarness of Anti-diabetic Brands

The survey concluded that all doctors know about both brands Huminsulin-R. They said brands

are most commonly prescribed. There is no hesitation in writing these brands. Brand have

given excellent result. The patient to whom this brands are prescribed they have given positive

response.

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Metformin Levemir

93

Data Analysis and Interpretation for Chemist Questionnaire

Daily Prescription of Anti-diabetic

Interpretation:

Daily prescription rate of of Antidiabetic drugs is more in quantity as a result of this question

reply by the chemist is as antidiabetic prescribe by doctor is at the high rate. Average

prescription rate is 10 to 15 prescription daily.

19

35

39

7

Sales

1 to 5

5 to 10

10 to 15

15 to 20

94

Patients asking for the self prescription of of Antidiabetic

Interpretation:

As the result come after the chemist response for the self prescribing by the patient is due to

the prescription repeating or the result of antidiabetic thus the data shows that the self

prescription of antidiabetic by the patient himself is much higher than the normal

prescription.

68

32

Demand

Yes

No

95

Patients purchase the Specific Brand due to

Interpretation:

Patients purchase the specific brand due to the low price and as per the doctor‘s prescription

and the patient has less perception of efficacy in mind while purchasing of the particular

antidiabetic brand

28

39

33

Self Prescription Reason

Doctors Rx

Low Price

Efficacy

96

Chemist keeps the stock of specific Antidiabetic Brand due to

Interpretation:

Chemists keep stock of specific brand of antidiabetic due to the Medical Representative

influence them about the brand and secondary they kept due to the low price of the brand

42

0

39

19

Reason

MR Influence

Direct Adv.

Low Price

Profit Earn

97

Chemist are Aware of Huminsulin-R

Interpretation:

During the survey the result has come to see that chemist is aware of the Huminsulin-R brand

of antidiabetic and they are well known of the efficacy and result of the Huminsulin-R.

100

0

Awareness

Yes

No

98

If yes then either they have or no stock of Huminsulin-R

Interpretation:

Most of the chemists are aware of the Huminsulin-R and they keep the stock of Huminsulin-

R and the amount of chemist which are not keep the stock of the Huminsulin-R due to their

specific reason which they don‘t want to disclosed during the survey.

79

21

Stock

Yes

No

99

Huminsulin-R is Sold due to either MR Influence, Low Price or Margin of profit

Interpretation:

According to the chemist response sales of the Huminsulin-R is due to the low price and

same where Medical Representative Influences and every few has response for the margin of

profit.

35

52

13

Reason

MR Influence

Low Price

Margin of Profit

100

Chemist are personally prefer Huminsulin-R either Yes or No

Interpretation:

According to the chemist response for the personal preference of Huminsulin-R has shown

the result as Approximately 80% of chemist are prefer Huminsulin-R personally and use the

Huminsulin-R. whereas remaining percentage of chemist doesn‘t pre fer it due to their

specific reason but many of the chemist personally prefer Huminsulin-R.

71

29

Preference

Yes

No

101

CONCLUSION

Now a days Diabetes is a very common disorder in India as well as through out the world.

Every fifth person is suffered by the diabetes disorder. India is an expanding stage in Anti-

diabetic market. In coming few years India is become the top position for diabetic

patient/Market. Currently US & Japan are the major market for diabetic drug. In India

diabetic care division is growing two digit growth nearly about 20% Growth rate. Anti-

diabetic segment covers 6% overall Pharma industry.

In India Eli Lilly is a market leader in Anti-diabetic drug having 60% share. Eli

Lilly is also world leader in Anti-diabetic drug. In India Novo Nordisk & Eli Lilly have

82% share in this segment.

From doctors perception about diabetes is not a serious disorder, but it affects

the individual‘s life. In diabetes there is no place of sweet. Diabetes is not a curable but it

is controllable through some tips. Only anti- diabetic drugs are not controlle the diabetes

with this drug Daily exercise, diet management & Yoga is play an important role to

controlle the diabetes.

The aged (old) people suffer more towards the diabetes disorder. There are lots

of factors responsible for diabetes.

102

LIMITATION OF THE STUDY

Few doctors were reluctant to give proper information and few of them were

unreachable.

The survey is carried out only in Navi Mumbai Dist. And some part of Mumbai. So

the interpretation drawn from the data available may be insufficient to comment on

the launch of the product in other cities of the country.

103

SUGGESTION AND RECOMMENDATION

Summary of Analysis –

As we look on to the insulin, it show prolong action to treating diabetes. Insulin is

available in the form of humulin…but this insulin are expensive therefore its market is

just 30% among diabetes drug. in spit of being expensive yet it is demanded in the

market. It show that it is increasing at the rate of 27% in the market. If the

manufacture could make insulin little less than before then insulin could be used by

more and more diabetes patients.

The cheapest drug found in the market is Daonil by Aventis which is at Rs 18 for

10tablets and semi Dao nil for Rs. 9for 10tablets. This daonil tablets were extremely

used in last two decades as the other firm drug come in to the market. Which more

effective but just above the price. As per the information, drug manufactures are

increasing the price which can effect their share mostly. The ant diabetic are available

in the price range from Rs.28 to Rs.135 according to their R&d cost and strength

availability price must be frequently low then the market price.

104

APPENDIX

ANNEXURE-I

LIST OF DOCTORS NAME

S.NO Doctor Name Qualification Category

1 A L joshi MD Cons.Phys

2 A M Nike MBBS Cons.Phys

3

ABHISAR

KATIYAR MS ORTHO Ortho

4 ABJALPURKAR MBBS G.P.

5 AJAY MEHETA MD physician

6 AL PARMAL MBBS G.P.

7 ALKANANDA DAS MBBS physician

8 AMOD DIVEKAR MS ORTHO Ortho

9 ANIL DONGRE MD.DPM Psychiatrists

10 ANIL MEHETA MBBS G.P.

11 ANIL SHANKAR MBBS G.P.

12 ANIL TALATHI MBBS G.P.

13 ARVIND JOSHI MD physician

105

14 ARVIND KOTOC MBBS G.P.

15 ASHOK BHOIR MBBS G.P.

16 ASHOK JADHAV MD physician

17 ayati ganhi md Cons.Phys

18 B G MEHTA MBBS G.P.

19 B. KHEDEKAR MBBS G.P.

20 B.G.KAMBLE MD physician

21 B.J.SHINDE MD physician

22 C.D. KULKARNI MBBS G.P.

23 D.A. SHIRODKAR MD physician

24 D.V.DIVEKAR MBBS G.P.

25 deepak mane md dpm Psychiatrists

26 DEEPAK PUROHIT MS ORTHO Ortho

27

DEEPAK

WAJEKAR MBBS G.P.

28 DEPALI MANE MBBS G.P.

106

29

DEVIDAS

GHANATE MD physician

30 DILIP JAIN MBBS G.P.

31

FAIZAL

DESHMUKH MD physician

32

FARAH

NAZAEKAR MBBS G.P.

33 G.S.KADAM MBBS G.P.

34 G.S.PATIL MBBS G.P.

35

HARSHAL

WALINGKAR MS ORTHO Ortho

36 HEMANT DALVI MD physician

37 j n kolhe Mbbs G.P.

38 jagdish bedekar mbbs,md physician

39 K C METHA MBBS G.P.

40 kaustik seth Mmbs G.P.

41 KIRTI SAMUDRA MD physician

42 KUMAR SHINDE MBBS G.P.

43 L.D.PATIL MBBS G.P.

44 M.L. LAD MD physician

45 M.M. DOSHI MBBS G.P.

107

46 Madhav g bhaware md physician

47 MADHURI KALITA MBBS Cons.Phys

48 madhusudan joshi md G.P.

49

SHAILESH

PAREKH MD PHY.

50 GIRISH MOHAARI MD PHY.

108

ANNEXURE-II

LIST OF CHEMIST SHOP

S No. Chemist Shop Name

1 Shree krishna medical store

2 Minal medical store

3 Swami narayan medical store

4 Rahul medical store

5 Sukhwani medical store

6 Kapil medical store

7 Shweta medical store

8 M D sukhwani medical store

9 Shree medicose

10 Vikas medicose

11 Life line medical store

12 Sifa medical store

13 Jay medical store

14 Shree param medical store

15 Punit medical store

16 Subhash medical store

17 Tapti health service private limited

18 Jivan jyoti medical store

19 Medi sales

20 Ashok medical store

21 Happy medical store

22 Roz medical

23 Saikripra medical store

109

24 Pawan medical store

25 Ashish medical store

26 Ruby pharmacy

27 Khandelwal medical store

28 Sahara medical store

29 Priyanka medical store

30 Shreenath medical store

31 Mir pharma

32 Mahendra medical store

33 Yash medical store

34 Atharav medical store

35 Vinus medical store

36 Natraj medical store

37 Pooja pharma

38 Hatmi medical store

39 Sarthak medical store

40 Hariom medical store

110

ANNEXURE-III

Doctors Questionnaire

Name-

Qualification

Age-

Specialty-

Area-

111

Questionnaire:

1. How Many diabetes patient treat in one month ? ______________

2. What type of diabetes patients approach you?

NIDD IDD

3. Diabetes is curable or controllable ? ______________________

4. Is Diabetes is a serious disorder ?

YES NO

5. Does Herbal drug, Exercise, Yoga help to control the disorder?

_____________________________________________________________

6. Can Nutrition (diet) play important role to control diabetes?

YES NO

If yes which type of nutritional supplement do you prefer to your patient ?

__________________________________________________________

7. What drugs do you use in the following cases:

a) Insulin Dependent Diabetes

______________________________________________________________

b) Non Insulin Dependent Diabetes

______________________________________________________________

8. Do you fill that the cost of the treatment you prescribe is affordable to patient?

YES NO

9. Have you seen any side effects of the anti – diabetic drug you prescribe?

YES NO

If yes, what

____________________________________________________________

10. Are you aware of brands Huminsulin-R?

Huminsulin-R YES NO

11. Can you describe the advantages of the Huminsulin-R

____________________________________________________________

112

ANNEXURE-IV

QUESTIONNAIRES

Chemist Questionnaire

Shop Name-

Area-

Nearby Doctor-

113

1. What is the Daily Prescription of Antidiabetic?

a) 1-5

b) 5-10

c) 10-15

d) 15-20

2. Is Patients asking for the self prescription of Antidiabetic?

a) Yes

b) No

3. Patients purchase the Specific Brand due to

a) Doctors prescription

b) Low Price

c) Efficacy

4. You keep the stock of specific Antidiabetic Brand due to

a) Influence of MR

b) Direct Advertisements

c) Low Price

d) Profit Earn

5. Are you aware of Huminsuli-R?

a) Yes

b) No

6. If yes then do you have stock of Huminsuli-R?

a) Yes

b) No

7.

8. Huminsuli-R is Sold due to

a) MR Influence

b) Low Price

c) Margin of profit

9. Do you personally prefer Huminsuli-R?

a) Yes

b) No

114

ANNEXURE-V

REFERENCES

BOOKS REVIEW:

a) Michael Wilson, Rod McNab, Brian Henderson

Bacterial Disease Mechanisms - An Introduction to Cellular Microbiology

Cambridge University Press April 2002

b) Edited by Charles J Dutton, Mark A Haxell, Hamish A. I. McArthur and Richard

G. Wax

ANTIDIABETIC - Discovery, Modes of Action, and Applications

Marcel Dekker December 2001

c) Edited by Wilson & Gisvold's

Wilson & Gisvold's Textbook of Organic Medicinal and Pharmaceutical Chemistry

11th Ed.

Oregon State University, Corvallis.

d) Edited by K Kummerer

Pharmaceuticals in the Environment - Sources, Fate, Effects and Risks - 3rd

Edition

Springer 2008

e) Alan Nathan

Non-Prescription Medicines 2nd Edition

f) Stuart Hogg

Essential Microbiology

Wiley June 2005

g) Research Methodology

By Uma Shekharan

Websites

www.wikipedia.com

www.diabeticindia.com

www.diabeticinformationhub.com

www.cygnusindia.com

www.herbalgram.org

www.marketresearch.com

www.diabetescare.com www.thehindu.com