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- Title
Effects of Exenatide (Exendin-4) on Glycemic Control Over 30 Weeks in Patients With Type 2 Diabetes Treated With Metformin and a Sulfonylurea.
- Authors
Kendall, David M.; Riddle, Matthew C.; Rosenstock, Julio; Zhuang, Dongliang; Kim, Dennis D.; Fineman, Mark S.; Baron, Alain D.
- Abstract
OBJECTIVE -- This study evaluated the effects of exenatide, a novel incretin mimetic, in hyperglycemic patients with type 2 diabetes unable to achieve glycemic control with metformin-sulfonylurea combination therapy. RESEARCH DESIGN AND METHODS -- A 30-week, double-blind, placebo-controlled study was performed in 733 subjects (aged 55 ± 10 years, BMI 33.6 ± 5.7 kg/m², A1C 8.5 ± 1.0%; means ± SD) randomized to 5 µg subcutaneous exenatide b.i.d. (arms A and B) or placebo for 4 weeks. Thereafter, arm A remained at 5 µg b.i.d, and arm B escalated to 10 µg b.i.d. Subjects continued taking their dose of metformin and were randomized to either maximally effective (MAX) or minimum recommended (MIN) doses of sulfonylurea. RESULTS -- Week 30 A1C changes from baseline (±SE) were -0.8 ± 0.1% (10 µg), -0.6 ± 0.1% (5 µg), and +0.2 ± 0.1% (placebo; adjusted P < 0.0001 vs. placebo), yielding placebo-adjusted reductions of -1.0% (10 µg) and -0.8% (5 µg). In the evaluable population, exenatide-treated subjects were more likely to achieve A1C ≤7% than placebo-treated subjects (34% [10 µg], 27% [5 µg], and 9% [placebo]; P < 0.0001). Both exenatide arms demonstrated significant weight loss (-1.6 ± 0.2 kg from baseline each exenatide arm, -0.9 ± 0.2 kg placebo; P ≤ 0.01 vs. placebo). Mild or moderate nausea was the most frequent adverse event. The incidence of mild/moderate hypoglycemia was 28% (10 µg), 19% (5 µg), and 13% (placebo) and appeared lower with MIN than with MAX sulfonylurea treatment. CONCLUSIONS -- Exenatide significantly reduced A1C in patients with type 2 diabetes unable to achieve adequate glycemic control with maximally effective doses of combined metformin-sulfonylurea therapy. This improvement in glycemic control was associated with no weight gain and was generally well tolerated.
- Subjects
DIABETES; PEOPLE with diabetes; PLACEBOS; THERAPEUTICS; HYPOGLYCEMIA
- Publication
Diabetes Care, 2005, Vol 28, Issue 5, p1083
- ISSN
0149-5992
- Publication type
Article
- DOI
10.2337/diacare.28.5.1083