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What’s New in Diabetes Therapy: The Good News for Your Patients

This article discusses the latest FDA approved medications, insulin preparations, prevention of Type 2 Diabetes, glucose monitor advances, and advancements in Type 1 Diabetes. It also explores the potential future treatments using incretins.

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What’s New in Diabetes Therapy: The Good News for Your Patients

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  1. What’s New in Diabetes Therapy:The Good News for Your Patients LCDR Alexis Epperly March 2007

  2. Goals • Review New FDA Approved Medications • Review New Insulin preparations • Prevention of Type 2 Diabetes • Glucose Monitor advances • Review Type 1 Diabetes advances • What’s on the horizon

  3. Incretins • GI tract secretes glucoregulatory hormones • Glucagon-Like Peptide 1 (GLP-1) • Secreted by L cells of the ileum • Inhibits gastric emptying and glucagon secretion • Stimulates insulin secretion • T1/2: 2 minutes • GLP-1 injection causes beta cell hypertrophy in rats • Glucose-dependent Insulinotropic Peptide (GIP) • Stimulates pancreas to secrete amylin Reddy,S. Endocrinology update 2006. Clev Clin J Med,2006.

  4. Exenatide (Byetta) • Analogue of GLP-1, FDA approved in 2005 • Mechanism: promotes glucose-dependent insulin secretion • Indications: Adjunctive therapy of Type 2 DM, when patients have failed first line oral therapy • Dose: 5-10 mcg SQ BID < 60 minutes prior to breakfast and dinner • Adverse effects: nausea (44%), diarrhea (13%), hypoglycemia (4-27%, alone and with metformin/sulfonylurea) • Secondary benefit: weight loss • Cost: $183-215/month http://uuhsc.utah.edu/pharmacy/bulletins/exenatide.html

  5. Amylin • Stored in beta cells • Co-secreted with insulin. • Decreases gastric emptying, suppresses glucagon secretion/glucose production, promotes satiety, and decreases appetite. • Decreased levels in all diabetics • Type I lowest levels, no response to meals Reddy,S. Endocrinology update 2006. Clev Clin J Med,2006.

  6. Pramlintide (Symlin) • Analogue of amylin, FDA approved in 2005 • Mechanism: slows gastric emptying, suppresses glucagon secretion, increases satiety • Indication: adjunct to mealtime insulin when optimal insulin therapy fails to produce adequate glucose control • Dose: • Type 1 DM 15-60 mcg SC AC • Type 2 DM 60-120 mcg SC AC • Adverse effects: nausea (30%), HA, fatigue, risk of insulin-induced hypoglycemia, weight loss • Cost: $99 -357/month http://uuhsc.utah.edu/pharmacy/bulletins/pramlintide.html

  7. Sitagliptin phosphate (Januvia) • DPP-4 inhibitor, FDA approved Oct 2006 • Mechanism: prolongs activity of incretins • Indication: Adjunct to diet and exercise in Type 2 DM alone or in combination with metformin or TZD • Dose: 100 mg daily • Adverse effects: URI, sore throat, diarrhea • Cost: $175/month http://uuhsc.utah.edu/pharmacy/bulletins/html

  8. New Insulin Preparations Inhaled insulin • Physiology: • Alveolar surface area and vascularity enhance absorption • Time of onset comparable to fast-acting SC insulin • Bioavailability 10% that of SC insulin Reddy,S. Endocrinology update 2006. Clev Clin J Med,2006.

  9. Inhaled Insulin (Exubera) • Dry-powder oral inhalation, FDA approved Jan 2006 • Mechanism: absorbed via pulmonary vasculature. Rapid onset of action, comparable to short-acting insulin. Bioavailability only 10% compared to SC insulin. • Indications: Type I or Type II DM for pre-meal dosing • Dose: Initial pre-meal dose 0.05 mg/kg, adjust as needed. • 3 mg inhaled insulin comparable to 9 units SC • Adverse effects: mild cough (most common); PFT decline (need PFT’s pre-Rx); hypoglycemia • Cost: $120 per month

  10. Detemir (Levimir) • Insulin analogue, rDNA, FDA approved 2005 • Mechanism: long acting insulin, released more slowly than human insulin with stable AUC • Indication: Type 1 DM adult and pediatrics, Type 2 DM adult requiring long acting insulin • Dose: 10 units daily, titrate as required • Adverse effects: hypoglycemia, possible bid dosing due to shorter T1/2 than insulin glargine • Cost: $30/3ml, $77/10ml

  11. ADA 2007 Guidelines for Stepwise Treatment of Type 2 DMGoal: HgbA1C < 7 • First line: diet, exercise, metformin • Add: sulfonylurea, TZD, or basal insulin • Add: another agent from above list • Or intensify insulin • Add or intensify insulin • Final: intensive insulin + metformin +/- TZD American Diabetes Association. Standards of Medical Care in Diabetes—2007. Diabetes Care. 2007.

  12. Potential Roles for New Meds in Stepwise Treatment of Type 2 DM • First line: diet, exercise, metformin • Sitagliptin could be used as first-line med • Add: sulfonylurea, TZD, or basal insulin • Exenatide could be added here • Add: another agent from above list • Or intensify insulin • Exenatide could be added here • Pramlintide can be added to mealtime insulin • Add or intensify insulin • Pramlintide can be added to mealtime insulin • Final: intensive insulin + metformin +/- TZD

  13. Prevention of Type 2 Diabetes • Diabetes Prevention Program Research Group 2002 Study • Pre-diabetics randomized to 3 groups: • Lifestyle intervention - 58% reduction DM incidence • Metformin plus standard education – 31% reduction • Placebo • Other studies (China, Finland) found similar results • Possible protective effects of ramipril, pravastatin DPPRG. Reduction in the Incidence of Type 2 Diabetes with Lifestyle Intervention or Metformin. NEJM.2002 Reddy,S.Endocrinology update 2006. Clev Clin J Med,2006.

  14. Advances in Glucose Monitors • GlucoWatch G2 Biographer • Gives glucose reading every 10 min • Noninvasive • Poor correlation when BG low • Does not replace finger stick monitoring • Cardiocheck • Glucose, total cholesterol, ketone, triglyceride, HDL within 60 seconds each

  15. Type 1 Diabetes • Pancreas Transplants • Islet cell transplants • 90% require insulin after 5 years • Early research suggests exenatide may delay insulin requirement • Partial Pancreas transplants • Preferred when receiving kidney from relative • Protects kidney from damage • Full Pancreas transplants • Limited by effects of immunosuppressive medications • 50% rejected • Indicated for Type 1 DM requiring kidney transplant Al Ghofaili, K. Effect of Exenatide on B Cell Function After Islet Transplantation in Type 1 Diabetes. Transplantation,2007 www.diabetes.org1/25/2007

  16. The Horizon • GLP-1 analogues resistant to proteases • Oral insulin (Emisphere,Inc.) being studied – results look promising • Role of Vitamin D deficiency or insufficiency in development of Type I DM • Gene therapy

  17. Acknowledgements • Dr Senkei Yoshida, USNH Okinawa, Japanese National Internship Program, 2006-2007

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