Incretin Hormones: Evolving Treatment Strategies For Type 2 Diabetes

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1 WHAT EVERY PRACTITIONER SHOULD KNOW ABOUT Incretin Hormones: Evolving Treatment Strategies For Type 2 Diabetes Education Partner:

2 What Every Practitioner Should Know About Incretin Hormones: Evolving Treatment Strategies for Type 2 Diabetes Learning Objectives Discuss the pathophysiology and management of type 2 diabetes, including updates on incretin hormones and combination therapies. Identify 2 newer approaches to achieve long-term glycemic control and A 1c targeted goals in patients with type 2 diabetes. Faculty Frank Lavernia, MD Founder, North Broward Diabetes Center Private Practice Internal Medicine and Diabetes Coconut Creek, Florida Dr Frank Lavernia (known to his patients as Dr Frank), has been a practicing diabetologist for 25 years in South Florida. He was the founder of the North Broward Diabetes Center, at the North Broward Medical Center, in Pompano Beach, Florida. This center has been accredited by the American Diabetes Association since Dr Frank is on various national faculties including the National Diabetes Education Initiative (a think tank for type 2 diabetes and insulin resistance), the Vascular Biology Working Group, and the Coalition for the Advancement of Cardiovascular Health. He is also on numerous national speaking bureaus within the pharmaceutical industry and lectures around the country. His private office has been accredited with the Certificate of Recognition for Diabetes Care by the American Diabetes Association for the last 6 years. His most recent project has been the development of Dr Frank s Diabetes Workshops to teach and empower people with diabetes. Charles Burant, MD, PhD Professor of Internal Medicine, and Molecular and Integrative Physiology University of Michigan Ann Arbor, Michigan Charles F. Burant, MD, PhD, is professor of internal medicine, and molecular and integrative physiology, at the University of Michigan in Ann Arbor. He also holds the Robert C. and Veronic Atkins Chair in Metabolism and is the director of the University of Michigan Metabolomics and Obesity Center. He is board certified by the American Board of Internal Medicine with subspecialty certification in endocrinology, diabetes and metabolism. Dr Burant earned both his medical degree and doctorate of philosophy in molecular and cellular biology from the Medical University of South Carolina in Charleston. Internship and residency both were served at the University of California in San Francisco, and Dr Burant completed his fellowship in the Department of Medicine, Endocrinology Section at the University of Chicago.

3 Dr Burant has held several memberships and offices in professional societies, including the American Diabetes Association, Central Society for Clinical Investigation, the American College of Physicians, and the American Association of Clinical Endocrinology. He is editor or the American Diabetes Association s Guide to the Medical Management of Type 2 Diabetes. Dr Burant is a recipient of many awards, including both the American Diabetes Association s and the American Medical Association s Award for Outstanding Research, and the Medical Scientist Training Program Award. He also has been elected to the Central Society for Clinical Research and serves on the Advisory Board for the National Diabetes Education Initiative. Faculty Financial Disclosure Statements As a continuing medical education provider accredited by the ACCME, it is the policy of Pri-Med Institute to require any individual in a position to influence educational content to disclose the existence of any financial interest or other personal relationship with the manufacturer(s) of any commercial product(s). The presenting faculty reported the following: Dr Lavernia has no relationship to disclose. Dr Burant receives monetary compensation as a scientific advisor from Takeda Pharmaceuticals North America, Inc. Education Partner Financial Disclosure Statements The content collaborators at Vindico Medical Education have reported that they have no relevant relationships to disclose. Conflict of Interest Resolution Statement When individuals in a position to control content have reported financial relationships with one or more commercial interests, as listed above, Pri-Med Institute works with them to resolve such conflicts to ensure that the content presented is free of commercial bias. The content of this presentation was vetted by the following mechanisms and modified as required to meet this standard: Content peer review by external topic expert Content validation by external topic expert and internal Pri-Med Institute clinical editorial staff Off-label/Investigational Disclosure In accordance with Pri-Med Institute policy, faculty have been asked to disclose discussion of unlabeled or unapproved use(s) of drugs or devices during the course of their presentations. Drug List Generic sitagliptin metformin sitagliptin + metformin exenatide pramlintide nateglinide repaglinide pioglitazone rosiglitazone glimepiride glipizide glyburide Trade Januvia Glucophage, Glucophage XR Janumet Byetta Symlin Starlix Prandin Actos Avandia Amaryl Glucotrol DiaBeta/ Micronase/Glynase

4 Investigational liraglutide saxagliptin alogliptin vildagliptin Galvus Suggested Reading List Mirza SA. Type 2 diabetes: the end of clinical inertia. South Med J. 27;1(8): Bolen S, Feldman L, Vassy J, et al. Systematic review: comparative effectiveness and safety of oral medications for type 2 diabetes mellitus. Ann Intern Med. 27;147(6): Wild S, Roglic G, Green A, et al. Global prevalence of diabetes: estimates for the year 2 and projections for 23. Diabetes Care. 24;27(5): Rosenstock J, Zinman B. Dipeptidyl peptidase-4 inhibitors and the management of type 2 diabetes mellitus. Curr Opin Endocrinol Diabetes Obes. 27;14(2): American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 27;3(suppl 1):S4-S41. Nathan DM, Buse JB, Davidson MB, et al. Management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: update regarding thiazolidinediones: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 28;31(1): Mitrakou A, Kelley D, Veneman T, et al. Contribution of abnormal muscle and liver glucose metabolism to postprandial hyperglycemia in NIDDM Diabetes. 199;39(11): Creutzfeldt W. The incretin concept today. Diabetologia. 1979;16(2): Drucker DJ. Enhancing incretin action for the treatment of type 2 diabetes. Diabetes Care. 23;26(1): Kieffer TJ, Habener JF. The glucagon-like peptides. Endocr Rev. 1999;2(6): Nauck MA, Kleine N, Orskov C, et al. Normalization of fasting hyperglycaemia by exogenous glucagonlike peptide 1 (7-36 amide) in type 2 (non-insulin-dependent) diabetic patients. Diabetologia. 1993;36(8): Kendall DM, Riddle MC, Rosenstock J, et al. Effects of exenatide (exendin-4) on glycemic control over 3 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care. 25;28(5): Buse JB, Henry RR, Han J, et al Effects of exenatide (exendin-4) on glycemic control over 3 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care. 24;27(11): DeFronzo RA, Bergenstal RM, Cefalu WT, et al. Efficacy of inhaled insulin in patients with type 2 diabetes not controlled with diet and exercise: a 12-week, randomized, comparative trial. Diabetes Care 25;28(8): Zinman B, Hoogwerf BJ, Duran Garcia S, et al. The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 27;146(7):

5 What are incretins What Every Practitioner Should Know About Incretin Hormones Evolving Treatment Strategies for Type 2 Diabetes 1. Pituitary factors that control glucagon secretion 2. Gastrointestinal hormones that affect insulin secretion 3. Pancreatic factors that influence GI motility 4. Plant-derived sterols that influence appetite 5. Animal-derived venoms Incretins have been shown to: 1. Increase gastric emptying 2. Delay first-phase insulin secretion 3. Reduce postprandial hyperglucagonemia 4. Increase beta cell mass in patients with type 2 diabetes 5. Improve erectile dysfunction Which incretin-based therapies do you currently use in your practice 1. Sitagliptin 2. Exenatide 3. Both sitagliptin and exenatide 4. I do not use incretin-based therapies Approved combination therapies include: 1. Sitagliptin + exenatide 2. Sitagliptin + insulin 3. Sitagliptin + metformin 4. Exenatide + insulin 5. Glitazones + pramlintide 73 million Americans with or at risk for diabetes Diabetes Care. 26;29:

6 YOUR treatment goals for patients with T2DM are: 1. A1C < 6% 2. A1C 6.5% 3. A1C < 7% 4. A1C < 8% What percentage of YOUR patients have achieved the ADA recommended minimal target of A1C < 7% 1. < 25% to 5% 3. 5 to 75% 4. > 75% ADA Recommended Goals for Type 2 Diabetes ADA Goals Measurements Goals A1C* <7% Preprandial capillary plasma glucose 7-13 mg/dl Peak postprandial plasma glucose <18 mg/dl Blood pressure <13/8 mm Hg Lipids LDL cholesterol Triglycerides HDL cholesterol ( ) HDL cholesterol ( ) <1 mg/dl (<7 mg/dl) <15 mg/dl >4 mg/dl >5 mg/dl * Therefore, the A1C goal for selected individual patients is as close to normal (< 6%) as possible without significant hypoglycemia A reduction in LDL to a goal of 7 mg/dl is an option in very-high-risk patients with overt CVD American Diabetes Association. Standards of Medical Care in Diabetes 28. Diabetes Care. 28 Jan 1; 31(Supplement 1):S Nathan DM. Diabetes Care. 26;29(8): A1C 7% should serve as a call to action to initiate or change therapy with the goal of achieving an A1C level as close to the non-diabetic range as possible or, at a minimum, decreasing the A1C <7%. 1 Therefore, the A1C goal for selected individual patients is as close to normal (<6%) as possible without significant hypoglycemia. 2 1 Nathan DM. Diabetes Care. 26;29(8): American Diabetes Association. Diabetes Care. 27;3:s4-s4 Type 2 Diabetes Lifestyle Intervention & Metformin ADA/EASD Global Treatment Strategy Add Basal Insulin Most Effective No A1C 7% Add Sulfonylurea Least Expensive Yes Add Glitazone No Hypoglycemia Yes No Yes No No A1C 7% A1C 7% A1C 7% Intensify Insulin Add Glitazone Add Basal Insulin Add Sulfonylurea No A1C 7% Yes No A1C 7% Add Basal or Intensify Insulin Yes Yes The ADA, EASD consensus treatment algorithm emphasizes the need for rapid addition (2 to 3 months) of medication and transition to new regimens when target glycemic goals are not achieved or sustained Intensive Insulin + Metformin +/- Glitazone Adapted from Nathan DM, et al. Diabetes Care. 26; 29: , and 27;3: Adapted from Nathan DM, et al. Diabetes Care. 26; 29: , and 27;3:

7 Case 1 37-year-old Hispanic woman who works as a high school teacher presents with a 3-year history of type 2 diabetes treated with metformin 1 mg b.i.d. A1C initially improved from 8.5% at diagnosis to 6.2% A1C has been increasing, and at most recent visit was 7.4% On review, A1C has been above 7 for approximately 1 months Lipid and blood pressure guidelines are maintained with a statin and ACE inhibitor BMI 31 kg/m 2 How would you manage her increasing A1C 1. Reinforce lifestyle modification 2. Increase metformin to 3 g 3. Add a sulfonylurea 4. Add nateglinide or repaglinide 5. Add a glitazone (TZD) 6. Add sitagliptin 7. Add exenatide 8. Add basal insulin 9. Add alpha glucosidase inhibitor 1.Reassure patient This is the Problem Bewildering treatment options due to the complex pathophysiology Discussion: Anti-Hyperglycemic Agents in Type 2 Diabetes Expected Interventions decrease in Advantages Disadvantages A1c (%) Step 1: Initial Lifestyle to 1-2 Low costs, many benefits Fails for most in first year Decrease weight and increase activity Metformin 1-2 Weight neutral, GI side effects, rare lactic acidosis inexpensive Step 2: Additional No dose limit, Injections, monitoring, hypoglycemia, weight gain therapy insulin inexpensive, improved lipid profile Sulfonylureas 1-2 Improved lipid profile Weight gain, hypoglycemia* Thiazolidinediones Potential decreased risk of Fluid retention, two-fold increase risk of CHF, potential (glitazones) MI increased risk of MI, atherogenic lipid profile, weight gain, expensive α-glucosidase inhibitors.5-.8 Weight neutral Frequent GI side effects, three ties/day dosing, expensive Exenatide.5-1. Weight loss Injections, frequent GI side effects, little experience Glinides Short duration Three times/day dosing, expensive, hypoglycemia Pramlinitide.5-1. Weight loss Injections, three times/day dosing, frequent GI side effects, expensive, little experience Sitagliptin.5-.8 Weight neutral Little experience, expensive *Severe hypoglycemia is relatively infrequent with sulfonylurea therapy. The longer-acting agents (e.g. chlorpropamide and glibenclamide glyburide) are more likely to cause hypoglycemia than glipizide, extended-release glipizide, glimepiride, or gliclazide. Pioglitazone. Rosiglitazone. Repaglinide is more effective at lowering A1C than nateglinide. GI, gastrointestinal; MI, myocardial infarction. Adapted from Nathan DM, et al. Diabetes Care. 28;31(1): The pathophysiology of T2DM includes three main defects Excess glucagon Islet α-cell produces excess glucagon Liver Diminished insulin β-cell produces less insulin Hyperglycemia Diminished insulin Pancreas 1. Insulin deficiency Muscle and fat 2. Excess glucose output 3. Insulin resistance Progressive Impairment in β-cell Function β-cell function (%) β-cell function declines, while... Diet/conv Rx (376) Metformin (159) SU/intensive (511) Years Years SU = sulfonylurea UK Prospective Diabetes Study Group. Diabetes. 1995;44: HbA 1c hyperglycemia increases 3

8 Glucose, insulin, glucagon after OGTT in T2DM Glucose mmol/l Insulin pmol/l Glucagon fmol/l Normal T2DM Mean ± SE arterial plasma glucose, insulin, and glucagon concentrations in nondiabetes (1) and non-insulin-dependent diabetic (1) subjects Let s take a closer look at how incretins affect this pathophysiology Minutes after glucose ingestion Mitrakou A, et al. Diabetes. 199;39: Characteristics of Incretins Modulation of Insulin and Glucagon Levels: The Enteroinsular Axis Gastrointestinal hormones (GLP-1 and GIP) Secreted in response to food ingestion Stimulate glucose-dependent insulin secretion Account for up to 6% of the insulin response in healthy subjects Suppress glucagon and may have effects on appetite and gastric emptying Short half-life (~2 minutes) due to rapid enzymatic degradation by DPP-4 Stedman s Medical Dictionary, 27 th ed, 2. Baggio LL and Drucker DJ. Treat Endocrinol 22. Holst JJ and Gromada J. Am J Physiol Endocrinol Metab 24;287:E199-E26. Nauck M et al. Diabetologia.1986;29:46 52 Baggio LL and Drucker DJ. Ann Rev Med 26;57: GLP-1 = glucagon-like peptide 1 GIP = glucose-dependent insulinotropic polypeptide DPP-4 = dipeptidyl peptidase 4 Gut Hormonal signals GLP-1 GIP Neural signals Nutrient signals alpha cells beta cells Adapted with permission from Creutzfeldt W. Diabetologia. 1979;16: Copyright 1979 Springer-Verlag. Drucker DJ. Diabetes Care. 23;26: Kieffer T et al. Endocr Rev. 1999;2: Nauck MA et al. Diabetologia. 1993;36: Glucagon (GLP-1) Pancreas Insulin (GLP-1,GIP) Incretin effect in T2DM Glucose (mmol/l) Insulin (mu/l) Normal Incretin 5 3 effect * * * * * * * * Time (min) Oral glucose (5 g) IV glucose (variable) T2DM Incretin effect Time (min) Nauck MA, et al. Diabetologia.1986;29: (mg/dl) (mg/dl) 4

9 Case 1: Review 37-year-old Hispanic female, high school teacher presents with a 3-year history of type 2 diabetes treated with metformin 1 mg b.i.d. A1C initially improved to 6.2% from 8.5% at initial presentation A1C has been increasing, and at most recent visit was 7.4% Lipid and blood pressure values are consistent with guidelines and maintained with a statin and an ACE inhibitor BMI 31 kg/m 2 How would you NOW manage her increasing A1C 1. Reinforce lifestyle modification 2. Increase metformin to 3 g 3. Add a sulfonylurea 4. Add nateglinide or repaglinide 5. Add a glitazone (TZD) 6. Add sitagliptin 7. Add exenatide 8. Add basal insulin 9. Add alpha glucosidase inhibitor 1. Do nothing Overview of Incretin-Related Therapies Classification of Incretin-Related Therapies GLP-1 Mimetics (injectable) Exenatide Exenatide LAR* GLP-1 Analogs (injectable) Liraglutide* Incretin enhancers (DPP-4 inhibitors) (oral) Sitagliptin Vildagliptin* Saxagliptin* Alogliptin* * Not currently approved Summary of Clinical Trial Data: Exenatide in Type 2 Diabetes Duration N (1μg) A1C (%) Weight (kg) Exenatide: Weight: 3-Year Completers + SU/MET 3 weeks SU 3 weeks MET 3 weeks TZD 16 weeks % -1.4 Monotherapy* 28 days *Not US FDA-approved indication Placebo subtracted Kendall DM. Diabetes Care 28: , 25. Poon T. Diabetes Technology and Therapeutics 7: , 25. Buse JB. Diabetes Care 27: , 24. Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes DeFronzo RA. Diabetes Care 28:192-11, 25. Mellitus. Available at: Zinman B. Annals of Internal Medicine k=1 No diet and exercise regimen was provided. N = 217; Mean (- SE); P<.1 from baseline to 3 years and between 3 weeks and 3 years. Klonoff DC, et al. Curr Med Res Opin 28; 24:

10 N = 217 Exenatide: Change in A1C and Weight After 3 Years Classification of Incretin-Related Therapies GLP-1 Mimetics (injectable) Exenatide Exenatide LAR* GLP-1 Analogs (injectable) Liraglutide* Klonoff DC, et al. Curr Med Res Opin 28; 24: Incretin enhancers (DPP-4 inhibitors) (oral) Sitagliptin Vildagliptin* Saxagliptin* Alogliptin* * Not currently approved Incretin Secretion and Metabolism Incretin Secretion and Metabolism Mixed Meal Incretin Release Active Incretins DPP-IV Rapid Inactivation (>8% of pool) Inactive Incretins Mixed Meal GLP-1(7-36) Active Incretins Active DPP-IV Inactive Incretins Plasma Plasma Incretin Actions DPP-IV = dipeptidyl peptidase-iv Deacon CF, et al. Diabetes. 1995;44: Renal Clearance Incretin Actions DPP-IV = dipeptidyl peptidase-iv Deacon CF, et al. Diabetes. 1995;44: Renal Clearance Sitagliptin Indications: Monotherapy, + Metformin, + Glitazone, + SU Initial Combination With Sitagliptin Plus Metformin Study Design Mean Change in A1C, % Monotherapy P<.1 Add-on to metformin study Metformin + placebo 224.% Metformin + sitagliptin 453 Rosenstock J, et al. Clin Ther. 26;28: Hermansen K, et al. Diabetes Obes Metab. 27; 9: Add-on to pioglitazone study Pioglitazone + placebo 174 Pioglitazone + sitagliptin 163 P<.1.2% P<.1.7%.9% All at 1 mg po qd for 24 weeks Add-on to glimepiride +/- metformin study +.3% 213 Glim +/- met + placebo P<.1* % Glim +/- met + sitagliptin Aschner P, et al. Diabetes Care. 26;29: Charbonnel B, et al. Diabetes Care. 26;29: Patients Not Using OHA or Monotherapy or Low-Dose OHA Combination Screening Period If on OHA: discontinue therapy OHA=oral antihyperglycemic; bid=twice a day. Goldstein B et al. Diabetes Care. 27;3: Diet and Exercise Run-In Period Eligible if A1C 7.5% 11% Single- Blind Placebo Run-in Period R Week 2 Day 1 Placebo Sitagliptin 1 mg qd Metformin 5 mg bid Metformin 1, mg bid Sitagliptin 5 mg/ Metformin 5 mg bid Sitagliptin 5 mg/ Metformin 1, mg bid Week 24 6

11 Initial Combination Therapy With Sitagliptin Plus Metformin Compared to Monotherapy Initial Combination Therapy With Sitagliptin Plus Metformin Study Percentage of Patients Achieving < 7% A1C at 24 Weeks LSM A1C Change From Baseline, % Week Placebo-Adjusted Results Mean A1C = 8.8% Monotherapy Combination Sitagliptin 1 mg qd Metformin 5 mg bid Metformin 1, mg bid Sitagliptin 5 mg + metformin 5 mg bid Sitagliptin 5 mg + metformin 1, mg bid a LSM change from baseline without adjustment for placebo; qd=once a day; bid=twice a day. Goldstein B et al. Diabetes Care. 27;3: Sitagliptin 5 mg + metformin 1, mg bid Metformin 1, mg bid Sitagliptin 1 mg qd Sitagliptin 5 mg + metformin 5 mg bid Metformin 5 mg bid Placebo To Goal, % a 44a 43 a a N = A1C <6.5% A1C <7% a P<.1 vs monotherapy. Goldstein B et al. Diabetes Care. 27;3: Sitagliptin Plus Metformin Study Change in Body Weight Glipizide-Controlled Sitagliptin Add-on to Metformin Noninferiority Study Weight Change and Incidence of Hypoglycemia Sitagliptin 5 mg + metformin 1, mg bid Metformin 1, mg bid Sitagliptin 1 mg qd Sitagliptin 5 mg + metformin 5 mg bid Metformin 5 mg bid Placebo Glipizide Sitagliptin 1 mg LSM Change From Baseline, kg Goldstein B et al. Diabetes Care. 27;3: LSM A1C Change From Baseline,..3.6 % Week LSM=least squares mean. Adapted from Nauck et al. Diabetes Obes Metab. 27;9: Incidence, % Incidence of Hypoglycemia at 52 Weeks P< Sitagliptin: Insulin Synthesis and Release 24-Week Monotherapy Study Proinsulin/insulin, pmol/l Proinsulin/insulin P.1* HOMA-β, % HOMA-β P.1* Do we need to adjust the dose of sitagliptin for patients with impaired renal function Baseline Week 24 Baseline Week 24 Baseline Week 24 Baseline Week 24 Placebo (22) Sitagliptin 1 mg (21) Placebo (235) Sitagliptin 1 mg (218) HOMA- β =homeostasis model assessment of beta-cell function. *Least-squares mean change from baseline vs placebo. Aschner P et al. Diabetes Care. 26;29:

12 Dose-Adjusted (to 5 mg) AUC, µm/h /h M µ, C U A ) g m 5 (to d te s ju d -A e s o D Sitagliptin AUC inf Increases With Decreasing Creatinine Clearance 8 4 AUC GMR increase <2-fold when CrCl >5 ml/min Dose adjustments <3 ml/min: ¼ dose 3 5 ml/min: ½ dose >5 ml/min: full dose Creatinine Clearance, ml/min Case 2 55-year-old Caucasian female postal worker, 15-year history of diabetes, on metformin 1 mg b.i.d. and glyburide 5 mg b.i.d. A1C has increased over the years to 8.2% Evidence of early microvascular complications (nonproliferative diabetic retinopathy) History of coronary artery disease, but no CHF Lipids, blood pressure and weight are well controlled Bergman AJ, et al. Diabetes Care. 27 Jul;3(7): How would you manage her increasing A1C 1.Reinforce lifestyle modification 2.Increase glyburide to 1 mg b.i.d. 3.Add a glitazone (TZD) 4.Add sitagliptin 5.Add exenatide 6.Add basal insulin Discussion: How would you manage her increasing A1C Treatment Option Reinforce lifestyle modification Increase glyburide to 1 mg b.i.d Add a glitazone (TZD); Add sitagliptin Add exenatide Add basal insulin Considerations It is never too late to reinforce lifestyle modification. However, it is not likely that this alone would get the patient to goal Wrong SU, Wrong dose CVD concerns, Fluid retention, Weight gain, Associated with decreased bone density Well tolerated, Weight neutral, No long-term safety data, Reports of hypersensitivity Weight reactions, loss, Expensive Injectable, Initial GI side effects, Pancreatitis, Expensive Greatest A1c-lowering potential, Hypoglycemia, Weight gain Shared Decision Making 48 Earlier and More Aggressive Intervention May Improve Patients Chances of Reaching Goal Customize therapy based on the following: Risk of hypoglycemia Cardiovascular status Renal status Weight A1C Cost Adherence Route of administration A1C, % Mean A1C of patients Published Conceptual Approach Diet and OAD OAD OAD OAD + exercise monotherapy up-titration combination basal insulin Duration of Diabetes OAD + multiple daily insulin injections Adapted from Del Prato S et al. Int J Clin Pract. 25;59: *OAD = oral antidiabetic 8

13 What are incretins 1. Pituitary factors that control glucagon secretion 2. Gastrointestinal hormones that affect insulin secretion 3. Pancreatic factors that influence GI motility 4. Plant-derived sterols that influence appetite 5. Animal-derived venoms Incretins have been shown to: 1. Increase gastric emptying 2. Delay first-phase insulin secretion 3. Reduce postprandial hyperglucagonemia 4. Increase beta cell mass in patients with type 2 diabetes 5. Improve erectile dysfunction Approved combination therapies include: 1. Sitagliptin + exenatide 2. Sitagliptin + insulin 3. Sitagliptin + metformin 4. Exenatide + insulin 5. Glitazones + pramlintide Conclusion Type 2 diabetes is a progressive disease characterized by ongoing beta cell failure Most patients with type 2 diabetes should be able to achieve an A1C goal of < 7% with the broad range of antihyperglycemic agents available Conclusion Early pharmacological intervention, combination therapy and persistent titration are often required to achieve these goals Incretin-based therapy can be used early and as a component of combination therapy DPP-4 inhibitors are well tolerated, weight neutral and not associated with hypoglycemia when used alone or in combination with metformin or TZDs 9

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