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- Title
Effects of Exenatide (Exendin-4) on Glycemic Control and Weight Over 30 Weeks in Metformin-Treated Patients With Type 2 Diabetes.
- Authors
DeFronzo, Ralph A.; Ratner, Robert E.; Han, Jenny; Kim, Dennis D.; Fineman, Mark S.; Baron, Alain D.
- Abstract
OBJECTIVE -- This study evaluates the ability of the incretin mimetic exenatide (exendin-4) to improve glycemic control in patients with type 2 diabetes failing to achieve glycemic control with maximally effective metformin doses. RESEARCH DESIGN AND METHODS -- A triple-blind, placebo-controlled, 30-week study at 82 U.S. sites was performed with 336 randomized patients. In all, 272 patients completed the study. The intent-to-treat population baseline was 53 ± 10 years with BMI of 34.2 ± 5.9 kg/m² and HbA[sup 1c] of 8.2 ± 1.1%. After 4 weeks of placebo, subjects self-administered 5 µg exenatide or placebo subcutaneously twice daily for 4 weeks followed by 5 or 10 µg exenatide, or placebo subcutaneously twice daily for 26 weeks. All subjects continued metformin therapy. RESULTS -- At week 30, HbA[sub 1c] changes from baseline ± SE for each group were -0.78 ± 0.10% (10 µg), -0.40 ± 0.11% (5 µg), and +0.08 ± 0.10% (placebo; intent to treat; adjusted P < 0.002). Of evaluable subjects, 46% (10 µg), 32% (5 µg), and 13% (placebo) achieved HbA[sub 1c] ≤7% (P < 0.01 vs. placebo). Exenatide-treated subjects displayed progressive dose-dependent weight loss (-2.8 ± 0.5 kg [10 µg], -1.6 ± 0.4 kg [5 µg]; P < 0.001 vs. placebo). The most frequent adverse events were gastrointestinal in nature and generally mild to moderate. Incidence of mild to moderate hypoglycemia was low and similar across treatment arms, with no severe hypoglycemia. CONCLUSIONS -- Exenatide was generally well tolerated and reduced HbA[sub 1c] with no weight gain and no increased incidence of hypoglycemia in patients with type 2 diabetes failing to achieve glycemic control with metformin.
- Subjects
TYPE 2 diabetes; PLACEBOS; THERAPEUTICS; HYPOGLYCEMIA; PEOPLE with diabetes; DIABETES
- Publication
Diabetes Care, 2005, Vol 28, Issue 5, p1092
- ISSN
0149-5992
- Publication type
Article
- DOI
10.2337/diacare.28.5.1092