Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: An interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials
Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: An interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials
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DOI：
10.1016/j.clinthera.2007.01.015
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发表时间：
2007-01-01
影响因子：
3.2
通讯作者：
Wintle, Matthew E.
中科院分区：
文献类型：
--
作者：
Buse, John B.;Klonoff, David C.;Wintle, Matthew E.
背景资料：艾塞那肽，一种肠促胰岛素类似物，用于连续治疗2型糖尿病（T2 DM），在30周安慰剂对照试验中降低糖化血红蛋白（HbA（1c））和体重。一些患者在开放标签扩展随访，以提供，“真实世界”exenlavin的临床experience.Objective：本研究的目的是检查2年exenlavin治疗T2DM.Methods患者的代谢影响：对于这个中期分析，数据汇总从谁完成了三个30周，多中心，双盲，安慰剂对照试验和他们的开放标签扩展I的患者。在最初的试验中，受试者被随机分配到BID 5 μ g艾塞那肽、10 μ g艾塞那肽或安慰剂组，持续30周。所有入组扩展期的受试者随后接受5 μ g艾塞那肽BID治疗4周，随后接受10 μ g艾塞那肽BID开放标签治疗。受试者继续其现有的二甲双胍和/或磺脲类药物治疗方案。对所有有机会实现2年exenvelope暴露的受试者的数据进行分析，无论他们的治疗臂在30周的安慰剂对照trials.Results：共有974例患者进入开放标签，扩展阶段的试验。283例受试者（平均[SD]年龄57 [10]岁;平均[SD]体重100 [19] kg;性别63%为男性;平均[SD]体重指数34 [6] kg/m2;平均[SD] HbA（1c）8.3% [1.0%]）完成了2年的艾塞那肽治疗。平均（SE）HbA（1c）从基线至第30周（-0.9% [0.1%]）的降低持续至2年（-1.1% [0.1%];与基线相比P < 0.05），50%的人群达到HbA（1c）
Background: Exenatide, an incretin mimetic for adjunctive treatment of type 2 diabetes mellitus (T2DM), reduced glycosylated hemoglobin (HbA(1c)) and weight in 30-week placebo-controlled trials. Some patients were followed up in open-label extensions to provide,'real-world' exenatide clinical experience.Objective: The purpose of this study was to examine the metabolic effects of 2 years of exenatide treatment in patients with T2DM.Methods: For this interim analysis, data were pooled from patients who completed I of three 30-week, multicenter, double-blind, placebo-controlled trials and their open-label extensions. In the initial trials, subjects were randomized to BID 5-mu g exenatide, 10-mu g exenatide, or placebo for 30 weeks. All subjects who enrolled in the extension phase then received 5-mu g exenatide BID for 4 weeks, followed by open-label treatment with 10-mu g exenatide BID. Subjects continued their existing metformin and/or sulfonylurea regimens. Analyses were conducted on data from all subjects who had the opportunity to achieve 2 years of exenatide exposure, irrespective of their treatment arm in the 30-week placebo-controlled trials.Results: A total of 974 patients entered the open-label, extension phase of the trial. Two hundred eighty-three subjects (mean [SD] age, 57 [10] years; mean [SD] weight, 100 [19] kg; sex, 63% male; mean [SD] body mass index, 34 [6] kg/m(2); mean [SD] HbA(1c) 8.3% [1.0%]) completed 2 years of exenatide treatment. Reductions in mean (SE) HbA(1c) from baseline to week 30 (-0.9% [0.1%]) were sustained through 2 years (-1.1% [0.1%]; P < 0.05 vs baseline), with 50% of the population achieving HbA(1c)