Glycemic Management in Type 2 Diabetes

Glycemic Management in Type 2 Diabetes

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AACE Comprehensive Care Plan

Disease management from a multidisciplinary team

Antihyperglycemic pharmacotherapy

Comprehensive diabetes self-education for the

patient

Therapeutic lifestyle change

Comprehensive Care Plan

2

Handelsman Y, et al. Endocr Pract. 2011;17(suppl 2):1-53.


Therapeutic Lifestyle Change

3

Components of Therapeutic Lifestyle Change

• Healthful eating• Sufficient physical activity• Sufficient sleep• Avoidance of tobacco products• Limited alcohol consumption• Stress reduction

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AACE Healthful Eating Recommendations

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Topic RecommendationGeneral eating habits

Regular meals and snacks; avoid fasting to lose weight Plant-based diet (high in fiber, low calories, low glycemic index, high in phytochemicals/antioxidants) Understand Nutrition Facts Label information Incorporate beliefs and culture into discussions Informal physician-patient discussions Use mild cooking techniques instead of high-heat cooking

Carbohydrate Understand health effects of the 3 types of carbohydrates: sugars, starch, and fiber Target 7-10 servings per day of healthful carbohydrates (fresh fruits and vegetables, pulses, whole

grains) Lower-glycemic index foods may facilitate glycemic control:* multigrain bread, pumpernickel bread,

whole oats, legumes, apple, lentils, chickpeas, mango, yams, brown riceFat Eat healthful fats: low-mercury/low-contaminant-containing nuts, avocado, certain plant oils, fish

Limit saturated fats (butter, fatty red meats, tropical plant oils, fast foods) and trans fats Use no- or low-fat dairy products

Protein Consume protein from foods low in saturated fats (fish, egg whites, beans) Avoid or limit processed meats

Micronutrients Routine supplementation not necessary except for patients at risk of insufficiency or deficiency Chromium; vanadium; magnesium; vitamins A, C, and E; and CoQ10 not recommended for glycemic

control*Insufficient evidence to support a formal recommendation to educate patients that sugars have both positive and negative health effects

AACE Medical Nutritional Therapy Recommendations

• Consistency in day-to-day carbohydrate intake• Adjusting insulin doses to match carbohydrate intake

(eg, use of carbohydrate counting)• Limitation of sucrose-containing or high-glycemic index

foods• Adequate protein intake• “Heart-healthy” diets• Weight management• Exercise• Increased glucose monitoring

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• ≥150 minutes per week of moderate-intensity exercise – Flexibility and strength

training– Aerobic exercise (eg, brisk

walking)• Start slowly and build up

gradually

• Evaluate for contraindications and/or limitations to increased physical activity before patient begins or intensifies exercise program

• Develop exercise recommendations according to individual goals and limitations

AACE Physical Activity Recommendations

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Antihyperglycemic Therapy

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Noninsulin Agents Available for Treatment of Type 2 Diabetes

Class Primary Mechanism of Action Agent Available as-Glucosidase inhibitors

Delay carbohydrate absorption from intestine

Acarbose Precose or genericMiglitol Glyset

Amylin analogue Decrease glucagon secretion Slow gastric emptying Increase satiety

Pramlintide Symlin

Biguanide Decrease HGP Increase glucose uptake in

muscleMetformin Glucophage or generic

Bile acid sequestrant

Decrease HGP? Increase incretin levels?

Colesevelam WelChol

DPP-4 inhibitors Increase glucose-dependent

insulin secretion Decrease glucagon secretion

Alogliptin NesinaLinagliptin TradjentaSaxagliptin OnglyzaSitagliptin Januvia

Dopamine-2 agonist

Activates dopaminergic receptors

Bromocriptine Cycloset

9HGP, hepatic glucose production.

Inzucchi SE, et al. Diabetes Care. 2012;35:1364-1379.

Noninsulin Agents Available for Treatment of Type 2 Diabetes

Class Primary Mechanism of Action Agent Available as

Glinides Increase insulin secretionNateglinide Starlix or genericRepaglinide Prandin

GLP-1 receptor agonists

Increase glucose-dependent insulin secretion

Decrease glucagon secretion Slow gastric emptying Increase satiety

Exenatide Byetta

Exenatide XR Bydureon

Liraglutide Victoza

SGLT2 inhibitor Increase urinary excretion of

glucoseCanagliflozin Invokana

Sulfonylureas Increase insulin secretion

Glimepiride Amaryl or genericGlipizide Glucotrol or generic

Glyburide Diaeta, Glynase, Micronase, or generic

Thiazolidinediones Increase glucose uptake in

muscle and fat Decrease HGP

Pioglitazone Actos

Rosiglitazone* Avandia

*Use restricted due to increased risk of myocardial infarction (MI)10

HGP, hepatic glucose production.Inzucchi SE, et al. Diabetes Care. 2012;35:1364-1379.

Insulins Available for the Treatment of Type 2 Diabetes

Class Primary Mechanism of Action Agent Available as

Basal

Increase glucose uptake Decrease HGP

Detemir LevemirGlargine Lantus

Neutral protamine Hagedorn (NPH) Generic

Prandial

Aspart NovoLogGlulisine ApidraLispro HumalogRegular human Humulin, generic

PremixedBiphasic aspart NovoLog MixBiphasic lispro Humalog Mix

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Pharmacokinetics of Insulin

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Agent Onset (h) Peak (h) Duration (h) Considerations

BasalNPH 2-4 4-10 10-16 Greater risk of nocturnal

hypoglycemia compared to insulin analogues

Glargine ~1-4 No pronounced peak*

Up to 24 hours†

Less nocturnal hypoglycemia compared to NPHDetemir

PrandialRegular ~0.5-1 ~2-3 Up to 8 Must be injected 30-45 min

before a meal Injection with or after a meal

could increase risk for hypoglycemia

Aspart <0.5 ~0.5-2.5 ~3-5 Can be injected 0-15 min before a meal

Less risk of postprandial hypoglycemia compared to regular insulin

Glulisine

Lispro

* Exhibits a peak at higher dosages.† Dose-dependent.

Moghissi E, et al. Endocr Pract. 2013;Feb 20:1-33. [Epub ahead of print].

Combination Agents Available for the Treatment of Type 2 Diabetes

Class Added Agent Available as

Metformin + DPP-4 inhibitor

Alogliptin Kazano

Linagliptin Jentadueto

Sitagliptin Janumet

Metformin + glinide Repaglinide Prandimet

Metformin + sulfonylureaGlipizide Metaglip and generic

Glyburide Glucovance and generic

Metformin + thiazolidinedionePioglitazone ACTOplus Met

Rosiglitazone* Avandamet

Thiazolidinedione + DPP-4 inhibitor Pioglitazone + alogliptin Oseni

Thiazolidinedione + sulfonylureaPioglitazone Duetact

Rosiglitazone* Avandaryl

*Use restricted due to increased risk of myocardial infarction (MI)

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Principles of the AACE/ACE T2DM Algorithm

• Ongoing lifestyle optimization essential– Requires support from full diabetes team

• Set A1C target based on individual patient characteristics and risk– ≤6.5% optimal if it can be achieved safely– Targets may change over time

• FPG and PPG regularly monitored by patient with SMBG

Garber AJ, et al. Endocr Pract. 2013;19:327-336.

Glucose Targets

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• Choose medications based on individual patient attributes– Minimize risk of hypoglycemia– Minimize risk of weight gain– Combine agents with

complimentary mechanisms of action for optimal glycemic control

• Prioritize safety and efficacy over medication cost– Medication cost small portion of

total cost of diabetes– Risk of adverse effects

considered part of “cost” of medication

• Evaluate treatment efficacy every 3 months– A1C, FPG, and PPG data– Hypoglycemia– Other adverse events (weight

gain; fluid retention; hepatic, renal, or cardiac disease)

– Comorbidities and complications

– Concomitant drugs– Psychosocial factors affecting

patient care

Principles of the AACE/ACE T2DM Algorithm

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Antihyperglycemic Medications

Common Principles in AACE/ACE and ADA/EASD T2DM Treatment Algorithms

• Individualize glycemic goals based on patient characteristics• Promptly intensify antihyperglycemic therapy to maintain

blood glucose at individual targets– Combination therapy necessary for most patients– Base choice of agent(s) on individual patient medical history,

behaviors and risk factors, ethno-cultural background, and environment

• Insulin eventually necessary for many patients• SMBG vital for day-to-day management of blood sugar

– All patients using insulin– Many patients not using insulin

20Inzucchi SE, et al. Diabetes Care. 2012;35:1364-1379.


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ADA/EASD T2DM Treatment Algorithm


ADA/EASD T2DM Treatment Algorithm: Sequential Insulin Strategies


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Early Insulin Use in Type 2 Diabetes

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ORIGIN Trial Investigators. N Engl J Med. 2012;367:319-328.

Outcome Reduction With an Initial Glargine InterventionCV risk factors + prediabetes or T2DM (N=12,537)

Pipeline Classes and Agents (2013)

ClassPhase of Development Agents Description

Dual peroxisome proliferator activated receptor - (PPAR-) agonistPhase 3

AleglitazarImprove insulin sensitivity in the periphery as well as lipid profilesApproved agents may reduce both cardiovascular risks and potential for diabetes complications

Short-acting GLP-1 receptor agonist Lixisenatide Human-derived molecule with effects similar to exenatide

Long-acting GLP-1 receptor agonistsPhase 3

AlbiglutideTaspoglutide

Effects probably similar to currently available GLP-1 receptor agonistsLonger duration of action will permit longer intervals between injections

Insulin Phase 3

Degludec Ultra-long-acting basal insulin (half-life ~25 hours) with low within-subject variability and potential for reduced incidence of hypoglycemia

DegludecPlus Premixed insulin containing degludec plus aspart, providing both fasting and postprandial glucose control

SalicylatesPhase 3

Salsalate Generically available anti-inflammatory medication currently approved for treatment of arthritis; inhibits activity of NF-B, an inflammatory factor

Sodium-dependent glucose cotransporter 2 (SGLT-2) inhibitorsPhase 3

DapagliflozinEmpagliflozinTofogliflozin

Act in the kidneyReduce hyperglycemia by inhibiting glucose reabsorption into the bloodstream from the renal filtrate, increasing urinary excretion of glucose

11-Hydroxysteroid dehydrogenase type 1 (11HSD-1) inhibitorsPhase 2

INCB13739RG4929

Inhibit 11HSD-1 mediated conversion of low-activity cortisone to cortisol, which is primarily produced in the liver and adipose tissueMay lessen stress-induced obesity, improve insulin sensitivity, enhance insulin-secretory responsiveness, and improve glucose tolerance in patients with metabolic syndrome and/or type 2 diabetes

24Bakris GL, et al. Kidney Int. 2009;75:1272-1277; Calado J, et al. Kidney Int Suppl. 2011:S7-S13;

Garber AJ. Expert Opin Investig Drugs. 2012;21:45-57; Goldfine AB, et al. Ann Intern Med. 2010;152:346-357;King A. J Fam Pract. 2012;61:S28-S31; Tahrani AA, et al. Lancet. 2011;378:182-197;

Tahrani AA, et al. Lancet. 2012;379:1465-1467.


Technology for Type 2 Diabetes Management

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Noninsulin Users• Introduce at diagnosis• Personalize frequency of

testing• Use SMBG results to inform

decisions about whether to target FPG or PPG for any individual patient

Insulin Users• All patients using insulin should

test glucose– ≥2 times daily– Before any injection of insulin

• More frequent SMBG (after meals or in the middle of the night) may be required– Frequent hypoglycemia– Not at A1C target

SMBG in Type 2 Diabetes: AACE/ACE Recommendations

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Testing positively affects glycemia in T2DM when the results are used to:• Modify behavior• Modify pharmacologic treatment

SMBG, self-monitoring of blood glucose.Handelsman Y, et al. Endocr Pract. 2011;17(suppl 2):1-53.

Active control group (n=227)Structured testing group (n=256)

7.2Baseline

7.4

7.6

7.8

8.0

8.2

8.4

8.6

8.8

9.0

M1 M3 M6 M9 M12

-0.3%(P=0.04)

Adj

uste

d M

ean

A1C

(%)

SMBG in Noninsulin Using Patients With T2DM

ACG, active cotnrol group; STG, structured testing group.Polonsky WH, et al. Diabetes Care. 2011;34:262-267.

ACG 8.9%(0.08)

8.7%(0.1)

8.2%(0.1)

7.9%(0.1)

8.0%(0.1)

8.0%(0.1)

STG 8.9%(0.07)

8.5%(0.09)

7.9%(0.09)

7.9%(0.09)

7.6%(0.09)

7.7%(0.09)

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• Absolutely insulin-deficient• Take 4 or more insulin

injections a day• Assess blood glucose levels 4

or more times daily• Motivated to achieve tighter

glucose control

• Mastery of carbohydrate counting, insulin correction, and adjustment formulas

• Ability to troubleshoot problems related to pump operation and plasma glucose levels

• Stable life situation• Frequent contact with members

of their healthcare team, in particular their pump-supervising physician

CSII in Type 2 Diabetes: Patient Candidates

CSII, continuous subcutaneous insulin infusion.Handelsman Y, et al. Endocr Pract. 2011;17(suppl 2):1-53.

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Surgical Intervention

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Surgical Intervention inType 2 Diabetes

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Schauer PR, et al. N Engl J Med. 2012;366:1567-1576.

MonthsMonths

3.5

2.5

1.5

0.50.0

1.0

2.0

3.0

Baseline 3 6 9 12

Aver

age

no. d

iabe

tes

med

icat

ions

P<0.001

P<0.001

-2

-6

-10-12

-8

-4

0

Baseline 3 6 9 12

B

MI (

kg/m

2 )P<0.001

P<0.001

20

-40

-100

-140-160

-120

-60

-20

-80

0

Baseline 3 6 9 12

F

PG (m

g/dL

)

P=0.02

P<0.001

0.0

1.0

2.0

3.03.5

2.5

1.5

0.5

Baseline 3 6 9 12

A

1C (%

)

P<0.001

P<0.001

Intensive medical therapy Sleeve gastrectomy Roux-en-Y gastric bypass


Safety Concerns: Hypoglycemia

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Type 2 Diabetes Pathophysiology: Origins of Hypoglycemia

Cryer PE. Am J Physiol. 1993; 264(2 Pt 1):E149-E155.

Defect

β-cells Increased insulin availability due to use of secretagogues or exogenous insulin

Liver Suppressed hepatic glucose production due to impaired counter-regulatory response

Skeletal muscle Increased glucose uptake due to exercise

α-cells Suppressed glucagon due to impaired counter-regulatory response

Brain Hypoglycemia unawareness

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Hypoglycemia: Risk FactorsPatient Characteristics

• Older age• Female gender• African American ethnicity• Longer duration of

diabetes• Neuropathy• Renal impairment• Previous hypoglycemia

Behavioral and Treatment Factors• Missed meals• Elevated A1C• Insulin or sulfonylurea

therapy

Miller ME, et al. BMJ. 2010 Jan 8;340:b5444. doi: 10.1136/bmj.b5444.

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0

1020

304050

6070

8090

100

Blood Glucose (mg/dL)

Decreased insulin secretion

Increased glucagon, epinephrine, ACTH, cortisol, and growth hormone

Palpitation, sweatingDecreased cognition, hungerAberrant behaviorSeizures, coma

Neuronal cell death


Symptoms and Signs with Progressive Hypoglycemia

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Hypoglycemia: Clinical Consequences

Acute• Symptoms (sweating,

irritability, confusion)• Accidents• Falls

Long-term• Recurrent hypoglycemia

and hypoglycemia unawareness

• Refractory diabetes• Dementia (elderly)• CV events

– Cardiac autonomic neuropathy

– Cardiac ischemia– Fatal arrhythmia– Angina

Cryer PE, et al. Diabetes Care. 2003;26:1902-1912.ADA. Diabetes Care. 2013;36(suppl 1):S11-S66.

Zammit NN, et al. Diabetes Care. 2005;28:2948-2961.

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Treatment of Hypoglycemia: AACE/ACE Recommendations

Cryer PE, et al. Diabetes Care. 2003;26:1902-1912.

Blood Glucose Level

Classification Typical Signs and Symptoms Treatment

~50-60 Mild hypoglycemia Neurogenic: palpitations, tremor, hunger, sweating, anxiety, paresthesia

Neuroglycopenic: behavioral changes, emotional lability, difficulty thinking, confusion

Consume glucose-containing foods (fruit juice, soft drink, crackers, milk, glucose tablets); avoid foods also containing fat

Repeat glucose intake if SMBG result remains low after 15 minutes

Consume meal or snack after SMBG has returned to normal to avoid recurrence

<50 Moderate hypoglycemia

Severe hypoglycemia

Severe confusion, unconsciousness, seizure, coma, death

Requires help from another individual

Glucagon injection, delivered by family member or other close associate

Victim should be taken to hospital for evaluation and treatment after any severe episode

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Elements of Hypoglycemia Prevention

Set appropriate glycemic targets for individual patients

More stringent goals: young, newly diagnosed, no comorbidities, no micro- or macrovascular disease, strong and effective self-care skills

Less stringent goals: older, limited life expectancy, history of hypoglycemia, longer disease duration, established comorbidities, established vascular disease, limited self-care skills

Educate patients

Signs and symptoms of hypoglycemia Dietary education for improved glycemic control and appreciation of triggers for

hypoglycemia Avoiding missed or delayed meals Appropriate self-treatment Understanding of hypoglycemia unawareness Importance of reporting hypoglycemia

Use self-monitoring of blood glucose

Patient education: technique and action Observation of patient’s procedure and reaction Patient access to providers for purposes of reporting results and for providing guidance Provider reaction to results increases effectiveness of SMBG

Hold a high index of suspicion for hypoglycemia

Understand patients may not report “typical” symptoms When hypoglycemia is suspected, adjust therapy Consider use of continuous glucose monitoring to detect unrecognized hypoglycemia

Choose appropriate therapy

Use agents with a low risk of hypoglycemia Be aware of additive effects of combination therapies on hypoglycemia risk Recognize that long-term costs of hypoglycemia may offset the cost of using older, less

physiologic medications37


GLP-1 receptor agonists

DPP-4 inhibitors

TZDs

Insulin (basal, basal-plus, premixed)

Sulfonylureas

Metformin

Less Hypoglycemia

MoreHypoglycemia

Initial Treatment Additional Treatment


Hypoglycemia Risk With Antihyperglycemic Agents Added

to Metformin

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Percentage of Patients Treated in 1 Year

0

1%

2%

3%

4%

5%

6% Mixtures, Rapid-acting, Basal-bolus

Insulin

Basal

Sulfonylureas

DPP-4 inhibitors, GLP-1 receptor agonists, Metformin, TZDs

Meglinitides

Frequency of Severe Hypoglycemia With Antihyperglycemic Agents


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Increasing rates of hypoglycemia

Most frequent

Prandial and

premixed

Morefrequent Basal +

Lessfrequent

Basal only

Human insulinAnalogue insulinsPremixed (70/30, 75/25)

Basal plus 2-3 prandialBasal plus one prandial

NPHBasal analogues (glargine, detemir) Pipeline basal analogues(degludec, pegylated lispro)


Relative Rates of Severe Hypoglycemia with Insulin

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Safety Concerns: Weight

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Antidiabetic Agents and Weight

• Risk of additional weight gain must be balanced against the benefits of the agent– Sulfonylureas may negate weight loss benefits of GLP-1 receptor agonists or

metformin– Insulin should not be withheld because of the risk of weight gain

Inzucchi SE, et al. Diabetes Care. 2012;35:1364-1379. Garber AJ, et al. Endocr Pract. 2013;19:327-336.Handelsman Y, et al. Endocr Pract. 2011;17(suppl 2):1-53. Stenlof K, et al. Diabetes Obes Metab 2013;15:372-382.

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Class Agent(s) Weight EffectAmylin analog Pramlintide ↓Biguanide Metformin ↓GLP-1 receptor agonists Exenatide, exenatide XR, liraglutide ↓SGLT-2 inhibitor Canagliflozin ↓-Glucosidase inhibitors Acarbose, miglitol ↔Bile acid sequestrant Colesevelam ↔DPP-4 inhibitors Alogliptin, linagliptin, saxagliptin, sitagliptin ↔Dopamine-2 agonist Bromocriptine ↔Glinides Nateglinide, repaglinide ↑Sulfonylureas Glimepiride, glipizide, glyburide ↑Insulin Aspart, detemir, glargine, glulisine, lispro, NPH, regular ↑↑Thiazolidinediones Pioglitazone, rosiglitazone ↑↑


Safety Concerns: Cancer Risk

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Insulin and Cancer Risk

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Study Hazard Ratio (95% CI)

Outcome Reduction With an Initial Glargine Intervention (ORIGIN)N=12,537; prospective RCTMedian follow-up: 6.2 years

Any cancer: 1.00 (0.88-1.13); P=0.97Death from cancer: 0.94 (0.77-1.15); P=0.52

Northern European Database StudyN=447,821; observationalMean follow-up:

Glargine users: 3.1 yearsOther insulin users: 3.5 years

Breast cancer (women): 1.12 (0.99-1.27)Prostate cancer (men): 1.11 (1.00-1.24)Colorectal cancer (men and women): 0.86 (0.76-0.98)

Kaiser-Permanente CollaborationN=115,000; observationalMedian follow-up:

Glargine users: 1.2 yearsNPH users: 1.4 years

Breast cancer (women): 1.0 (0.9-1.3)Prostate cancer (men): 0.7 (0.6-0.9)Colorectal cancer (men and women): 1.00 (0.8-1.2)All cancers (men and women): 0.9 (0.9-1.0)

MedAssurant Database StudyN=52,453; observationalMean follow-up:

Glargine users: 1.2 yearsNPH users: 1.1 years

No increased risk for breast cancer

ORIGIN Trial Investigators. N Engl J Med. 2012;367:319-328. Kirkman MS, et al. Presented at the American Diabetes Association 72nd Scientific Sessions. June 11, 2012. Session CT-SY13. Philadelphia, PA.


Special Populations and Situations

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Management Considerations for Elderly Patients with

Diabetes

46Bourdel Marchasson I, et al. J Nutr Health Aging. 2009;13:685-691. Handelsman Y, et al. Endocr Pract. 2011;17(suppl

2):1-53. Schwartz AV, et al. Diabetes Care. 2008;31:391-396. Zammitt NN, Frier BM. Diabetes Care. 2005;28:2948-2961.

Increased risk of and from falling

• Impaired vision• Reduced strength and

stamina• Sensitivity to

medication side effects• Frailty• Susceptibility to

hypoglycemia

Hypoglycemia unawareness and

recurrent hypoglycemia

• Impaired counter-regulatory mechanisms

Impaired capacity, understanding, and/or motivation for proper

self-care• Cognitive decline and

dementia• Depression• Impaired vision

Other complicating factors

• Diminished kidney function

• Urinary incontinence• Status of social support

and/or caregiver• Drug-drug interactions

Consider risks before prescribing:

• Sulfonylureas and glinides (hypoglycemia risk)• Thiazolidinediones (fracture risk)• Metformin (risk of lactic acidosis with decreased kidney function)

Consider when establishing treatment goals

• Patient overall health and well-being• Self-care capacities• Social/family support

Risk Considerations for Religious/Cultural Fasting

Risk Category Features

Low

Glycemia well-controlled with antihyperglycemic agent that does not cause hypoglycemia (eg, metformin, thiazolidinedione, DPP-4 inhibitor, GLP-1 receptor agonist)

Otherwise healthyModerate Glycemia well-controlled with glinides

High

Moderate hyperglycemia (A1C 7.5-9.0%), renal insufficiency, cardiovascular complications, and/or other comorbid conditions

Living alone, especially if taking sulfonylureas, insulin, or drugs that affect mentation Elderly, especially with poor health

Very high

History of recurrent hypoglycemia, hypoglycemia unawareness, or episode of severe hypoglycemia within 3 months prior to Ramadan

Poor glycemic control Ketoacidosis or hyperosmotic hyperglycemic coma within 3 months prior to Ramadan Acute illness or chronic dialysis Intense physical labor Pregnancy47

Al-Arouj M, et al. Diabetes Care. 2005;28:2305-2311.

Main Risks of Fasting• Hypoglycemia• Hyperglycemia• Diabetic ketoacidosis• Dehydration and thrombosis

Glycemic Management During Religious/Cultural Fasting

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Al-Arouj M, et al. Diabetes Care. 2005;28:2305-2311.

• Frequent glucose monitoring—break fast immediately if patient has: – Hypoglycemia

• SMBG <70 mg/dL while taking insulin or sulfonylureas• SMBG <60 mg/dL while on other therapies

– Hyperglycemia: >300 mg/dL• Healthful eating before and after each fasting period

– Complex carbohydrates prior to fast– Avoid ingesting high-carbohydrate, high-fat foods when breaking fast

• Avoid excessive physical activity but maintain normal exercise routines

• Avoid fasting while ill

Glycemic Management in Type 2 Diabetes

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