Effects of Exenatide (Exendin-4) on Glycemic Control Over 30 Weeks in Patients With Type 2 Diabetes Treated With Metformin and a Sulfonylurea

艾塞那肽 医学 安慰剂 二甲双胍 磺酰脲 2型糖尿病 内科学 血糖性 人口 低血糖 糖尿病 胃肠病学 内分泌学 胰岛素 替代医学 环境卫生 病理
作者
David M. Kendall,Matthew C. Riddle,Julio Rosenstock,Dongliang Zhuang,Dennis Dong Hwan Kim,Mark Fineman,Alain Baron
出处
期刊:Diabetes Care [American Diabetes Association]
卷期号:28 (5): 1083-1091 被引量:1170
标识
DOI:10.2337/diacare.28.5.1083
摘要

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.

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