Post on 06-Jul-2015
description
PROTOCoL DESIGN
Importance
Protocol is the most important of all clinical trial documents
It is also the first to be prepared and discussed with the
investigators.
“ It is a confidential document since it contains information on drug “
Definition
A document that states the background, objectives, rationale, design,
methodology (including the methods for dealing with
AEs,withdrawals etc) and statistical considerations of the study. It
also states the conditions under which the study shall be performed
and managed.
Background
To study the effect of oral sulfonylurea in patient with type -2 diabetes
mellitus not previously treated with drug therapy.
Study Objectives
To assess the effectiveness of oral sulfonylurea in patients with type-2
diabetes diagnosed keeping in view that the patient is receiving
medication for the first time.
Study Design
Open Label,
Treatment (Glimepiride)
Active Control,
Safety/Efficacy Study
Diabetes Mellitus :
a group of diseases characterized by high levels of blood glucose
resulting from defects in insulin production, insulin action, or both
2 Types:
1) Type 1 diabetes
Insulin dependent diabetes
2) Type 2 diabetes
Non insulin dependent diabetes
blood glucose levels rise due to
1) Lack of insulin production
2) Insufficient insulin action
Sample Introduction
Glimepiride is a medium-to-long acting sulfonylurea anti-diabetic drug. It is
marketed as Amaryl by Sanofi-Aventis and Glyree by Ipca. Glimepiride is the first
third-generation sulfonylurea, and is very potent.
It is sometimes classified as third-generation, and sometimes classified as second-
generation.
Mechanism of action:
Pancreatic effect
Extra-pancreatic effect
Pancreatic effect:
Increase insulin release from pancreas
Suppress secretions of Glucagon
Extra pancreatic effect:
Increases the number of insulin receptors
Increases post-receptor insulin sensitivity
Increases glucolysis
Increases glycogen storage in muscle and liver
Decreases the hepatic output of glucose
Selection Criteria
Subjects already taking medication for type-2 diabetes mellitus:-No
Age eligible for study:-18Years to 40 Years
Genders eligible for study:-Both
Accepts healthy volunteers:-No
Inclusion criteria
Exclusion criteria
Withdrawal Criteria
Study Treatment
Life style modification
Diet control
All diabetic patients should be on diet control.
Diet control is a must either the patient is taking insulin
or oral therapy.
Over weight should be reduced .
Exercise
Smoking cessation
Insulin
Oral agents
Mechanism of action:
Pancreatic effect
Extra-pancreatic effect
Glimepiride 2mg per day
Once daily. Half-life 9 hours, peak action for 4 hours.
Phase/Type
Phase 2/Open Study
Patient
Type
Patients with type 2 diabetes not previously treated
with diet or oral drug
Trial Size Multicenter trial
Design Active control & openly treated with orally Glimepiride
drug
Dosing 2mg. Once Daily Glimepiride
Endpoints HbA1c, body weight, fasting plasma glucose, safety
Treatment of Type 2 Diabetes
Diagnosis
Therapeutic Lifestyle Change
After 12 Week check
Oral Drugs Only
Lab Test
Flow Chat
Lab Test Para Meter
Laboratory Examination
Glucose (Fasting)
Not lass than 120 mg/dl
Glucose (PP)
Not lass than 160 mg/dl
Glucose Torrance Test (GTT)
Hemoglobin (In Blood)
Not less than 8.0 gms/dl
HbA1C(Glycocyated
Hemoglobin)
Laboratory Examination
Urine(Rotten, Microscope)RM
Safety (Hepatic, CVD,
Hypoglycemia – While realizing that
diabetes is a serious disease!)
Efficacy (glycemic control, risk
factor reduction)
Side Effects (weight gain)
Patient acceptability
Preventing Diabetes
Complications
Glucose control
Blood pressure control
Blood lipid control
Preventive care practices for eyes,
kidneys, feet, teeth and gums
ADVERSE EVENTS (AE) REPORTING
Study Sponsor Notification by Investigator
A adverse event must be reported to the study sponsor by
telephone within 24 hours of the event. A Serious Adverse Event
(SAE) form must be completed by the investigator and faxed to the
study sponsor within 24 hours
EC/IRB Notification by Investigator
Reports of all adverse events (including follow-up information) must be
submitted to the EC/IRB within 10 working days.
FDA Notification by Sponsor
The study sponsor shall notify the FDA by telephone or by facsimile
transmission of any unexpected fatal or life-threatening experience
associated with the use of the drug as soon as possible but no later than 7
calendar days from the sponsor’s original receipt of the information.
Other Components
Quality control and assurance(QC/QA)procedures
Ethics( IDMC process, EC, Confidentiality)
Monitoring/ Direct access to data
Data Handling and record keeping
Financing and Insurance
Publication policy
Any Questions