Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea
Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea
复制标题
DOI：
10.2337/diacare.28.5.1083
复制
发表时间：
2005-05-01
期刊：
影响因子：
16.2
通讯作者：
Baron, AD
中科院分区：
文献类型：
--
作者：
Kendall, DM;Riddle, MC;Baron, AD
目的-本研究评价了艾塞那肽，一种新型肠促胰岛素模拟物，在二甲双胍联合治疗无法达到血糖控制的2型糖尿病高血糖患者中的作用。研究设计和方法-在733名受试者中进行了一项为期30周的双盲安慰剂对照研究（年龄55 +/- 10岁，BMI 33.6 +/- 5.7 kg/m2，AlC 8.5 +/- 1.0%;平均值+/- SD），随机接受5 μ g皮下艾塞那肽b.i.d. (arms A和B）或安慰剂治疗4周。此后，A组保持5 μ g b.i.d.组B增加至10 μ g b.i.d.。受试者继续服用二甲双胍，并随机接受磺脲类药物的最大有效剂量（MAX）或最小推荐剂量（MIN）。结果-第30周AlC较基线的变化（+/- SE）分别为-0.8 +/- 0.1%（10 μ g），-0.6 +/- 0.1%（5 μ g）和+0.2 +/- 0.1%（5 μ g）。（安慰剂;调整的P < 0.000] vs.安慰剂），产生安慰剂调整的降低-1.0%（10 μ g）和-0.8%（5 μ g）。在可评估的人群中，艾塞那肽治疗的受试者比安慰剂治疗的受试者更有可能达到AlC ≥ 7%（34% [10 μ g]，27% [5 μ g]和9% [安慰剂]; P < 0.0001）。两个艾塞那肽组均表现出显著的体重减轻（每个艾塞那肽组较基线为-1.6 +/-0.2 kg，安慰剂组为-0.9 +/-0.2 kg; P
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 metforminsulfonylurea combination therapy.RESEARCH DESIGN AND METHODS - A 30-week, double-blind, placebo-controlled study was performed in 733 subjects (age 55 +/- 10 years, BMI 33.6 +/- 5.7 kg/m(2), AlC 8.5 +/- 1.0%; means +/- SD) randomized to 5 mu g subcutaneous exenatide b.i.d. (arms A and B) or placebo for 4 weeks. Thereafter, arm A remained at 5 mu g b.i.d. and arm B escalated to 10 mu g 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 AlC changes from baseline (+/- SE) were -0.8 +/- 0.1% (10 mu g), -0.6 +/- 0.1% (5 mu g), and +0.2 +/- 0.1% (placebo; adjusted P < 0.000] vs. placebo), yielding placebo-adjusted reductions of -1.0% (10 mu g) and -0.8% (5 mu g). In the evaluable population, exenatide-treated subjects were more likely to achieve AlC >= 7% than placebo-treated subjects (34% [10 mu g], 27% [5 mu g], 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