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Summaries for Patients are a service provided by Annals to help patients better understand the complicated and often mystifying language of modern medicine.
SUMMARIES FOR PATIENTS
Exenatide Therapy for Type 2 Diabetes
3 April 2007 | Volume 146 Issue 7 | Page I-18
Summaries for Patients are presented for informational purposes only. These summaries are not a substitute for advice from your own medical provider. If you have questions about this material, or need medical advice about your own health or situation, please contact your physician. The summaries may be reproduced for not-for-profit educational purposes only. Any other uses must be approved by the American College of Physicians.
The summary below is from the full report titled "The Effect of Adding Exenatide to a Thiazolidinedione in Suboptimally Controlled Type 2 Diabetes. A Randomized Trial." It is in the 3 April 2007 issue of Annals of Internal Medicine (volume 146, pages 477-485). The authors are B. Zinman, B.J. Hoogwerf, S. Durán García, D.R. Milton, J.M. Giaconia, D.D. Kim, M.E. Trautmann, and R.G. Brodows.
What is the problem and what is known about it so far?
Doctors often prescribe drugs to help patients with type 2 diabetes control their blood sugar. They use a blood test (called hemoglobin A1c) to assess sugar control. In most cases, doctors should aim for optimal control of sugar levels (hemoglobin A1c values less than 7%), depending on several factors. Some patients need more than 1 drug to get their blood sugar levels under optimal control. Drugs that may be used include insulin, alpha-glucosidase inhibitors (acarbose and miglitol), biguanides (metformin), sulfonyureas (glipizide or glyburide), and thiazolidinediones (TZDs, such as rosiglitazone and pioglitazone). Exenatide is a new drug called an incretin mimetic. Few studies have assessed whether adding this drug to TZD treatment improves sugar control.
Why did the researchers do this particular study?
To see whether adding exenatide to TZD treatment improves blood sugar control in adults with type 2 diabetes.
Who was studied?
233 middle-aged adults with suboptimal glucose control despite TZD treatment. The patients' average hemoglobin A1c value was 7.9%.
How was the study done?
The researchers recruited patients from 49 sites in Canada, Spain, and the United States. Patients were randomly assigned to twice-daily injections under the skin of either exenatide or placebo for 16 weeks. All patients were taking TZD pills, and some also took metformin pills. The researchers tested patients' blood for glucose levels, weighed patients, and asked patients about side effects. The researchers, doctors, and patients did not know who got exenatide or placebo.
What did the researchers find?
Exenatide reduced hemoglobin A1c levels by about 0.98% and body weight by about 3 pounds more than placebo. More patients who received exenatide than patients who received placebo had nausea (40% vs. 15%) or vomiting (13% vs. 1%).
What were the limitations of the study?
Treatment duration was only 16 weeks, and 29% of patients in the exenatide group and 14% of patients in the placebo group did not complete the study. Only patients who tolerated placebo injections during a 2-week "run-in" period were studied.
What are the implications of the study?
Adding exenatide to TZD treatment improves blood sugar control and reduces body weight by small amounts and also causes some nausea and vomiting.
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  S. L. Norris, D. Kansagara, C. Bougatsos, and R. Fu Screening Adults for Type 2 Diabetes: A Review of the Evidence for the U.S. Preventive Services Task Force Ann Intern Med, June 3, 2008; 148(11): 855 - 868. [Abstract] [Full Text] [PDF]
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 M. Salehi, B. A. Aulinger, and D. A. D'Alessio Targeting {beta}-Cell Mass in Type 2 Diabetes: Promise and Limitations of New Drugs Based on Incretins Endocr. Rev., May 1, 2008; 29(3): 367 - 379. [Abstract] [Full Text] [PDF]
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 C. L. Martin Beyond Glycemic Control: The Effects of Incretin Hormones in Type 2 Diabetes The Diabetes Educator, May 1, 2008; 34(Supplement_3): 66S - 72S. [Abstract] [Full Text] [PDF]
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 S. E. Inzucchi and D. K. McGuire New Drugs for the Treatment of Diabetes: Part II: Incretin-Based Therapy and Beyond Circulation, January 29, 2008; 117(4): 574 - 584. [Abstract] [Full Text] [PDF]
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 J. Rosenstock and V. Fonseca Missing the Point: Substituting Exenatide for Nonoptimized Insulin: Going from bad to worse! Diabetes Care, November 1, 2007; 30(11): 2972 - 2973. [Full Text] [PDF]
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 R. E. Amori, J. Lau, and A. G. Pittas Efficacy and Safety of Incretin Therapy in Type 2 Diabetes: Systematic Review and Meta-analysis JAMA, July 11, 2007; 298(2): 194 - 206. [Abstract] [Full Text] [PDF]
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Correction: The Effect of Adding Exenatide to a Thiazolidinedione in Suboptimally Controlled Type 2 Diabetes Ann Intern Med, June 19, 2007; 146(12): 896 - 896. [Full Text] [PDF]
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S. Malozowski Exenatide in Combination Therapy: Small Study, Big Market, and Many Unanswered Questions Ann Intern Med, April 3, 2007; 146(7): 527 - 528. [Full Text] [PDF]
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