The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes - A randomized trial
The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes - A randomized trial
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DOI：
10.7326/0003-4819-146-7-200704030-00003
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发表时间：
2007-04-03
影响因子：
39.2
通讯作者：
Brodows, Robert G.
中科院分区：
文献类型：
--
作者：
Zinman, Bernard;Hoogwerf, Byron J.;Brodows, Robert G.
背景：艾塞那肽联合二甲双胍或磺脲类药物治疗2型糖尿病是有效的。噻唑烷二酮类药物（TZDs）也是常用的药物，但艾塞那肽与TZD合用的疗效尚未报道。目的：比较艾塞那肽与安慰剂对血糖控制的效果。设计：安慰剂导入期，随机，双盲，安慰剂对照试验，从2004年5月至2005年8月进行。设置：加拿大，西班牙和美国的49个地点。患者：233例（艾塞那肽组，n = 121;安慰剂组，n = 112）TZD治疗（伴或不伴二甲双胍）控制欠佳的2型糖尿病患者。平均（SE）基线糖化血红蛋白A（1c）水平为7.9%+/-0.1%.Interventions：皮下腹部注射10 μ g艾塞那肽或安慰剂，每日两次，加入TZD（含或不含二甲双胍），持续16周。其他结果包括空腹血糖水平、体重、自我监测血糖水平和任何不良事件。艾塞那肽治疗降低血红蛋白A，c水平（平均差异，-0.98%[95% CI，-1.21%至-0.74%]），空腹血糖水平（平均差异，-1.69 mmol/L [-30.5 mg/dL][Cl，-2.22至-1.17 mmol/L {-40.0至-21.1 mg/dL}]）和体重（平均差异，-1.51 kg [Cl，-2.15至-0.88 kg]）。艾塞那肽组16%的患者和安慰剂组2%的患者因不良事件而停止治疗。在艾塞那肽组中，40%（n = 48）的患者发生恶心（大多数为轻度[n = 21]或中度[n = 19]），13%发生呕吐，11%发生低血糖。在安慰剂组中，15%的患者出现恶心，1%的患者出现呕吐，7%的患者出现低血糖。审判时间相对较短。只有71%和86%的患者在exengland和安慰剂组，分别完成了study.Conclusions：exengland治疗改善血糖控制，降低体重，并导致胃肠道症状比安慰剂2型糖尿病患者，是次优控制TZD治疗。
Background: Exenatide therapy is effective in combination with metformin or sulfonylureas for treating type 2 diabetes. Thiazolidinediones (TZDs) also are commonly used, but the efficacy of exenatide with a TZD has not been reported.Objective: To compare the effects of exenatide versus placebo on glycemic control.Design: Placebo run-in, randomized, double-blind, placebo-controlled trial conducted from May 2004 to August 2005.Setting: 49 sites in Canada, Spain, and the United States.Patients: 233 (exenatide group, n = 121; placebo group, n = 112) patients with type 2 diabetes that was suboptimally controlled with TZD treatment (with or without metformin). Mean ( SE) baseline glycated hemoglobin A(1c) level was 7.9% +/- 0.1 %.Interventions: Subcutaneous abdominal injections of 10 mu g of exenatide or placebo twice daily, added to a TZD (with or without metformin) for 16 weeks.Measurements: The primary outcome was change from baseline in hemoglobin A(1c) level. Other outcomes were fasting serum glucose level, body weight, self-monitored blood glucose level, and any adverse events.Results: Exenatide treatment reduced hemoglobin A,c level (mean difference, -0.98% [95% Cl, -1.21% to -0.74%]), serum fasting glucose level (mean difference, -1.69 mmol/L [-30.5 mg/dL] [Cl, -2.22 to -1.17 mmol/L {-40.0 to -21.1 mg/dL}]), and body weight (mean difference, -1.51 kg [Cl, -2.15 to -0.88 kg]). Sixteen percent of patients in the exenatide group and 2% of patients in the placebo group discontinued treatment because of adverse events. In the exenatide group, 40% (n = 48) of patients experienced nausea (mostly mild [n = 21] or moderate In = 19]), 13% experienced vomiting, and 11% experienced hypoglycemia. in the placebo group, 15% of patients experienced nausea, 1 % experienced vomiting, and 7% experienced hypoglycemia.Limitations: Combinations with TZDs and sulfonylureas were not tested. Trial duration was relatively short. Only 71 % and 86% of patients in the exenatide and placebo groups, respectively, completed the study.Conclusions: Exenatide therapy improved glycemic control, reduced body weight, and caused gastrointestinal symptoms more than placebo in patients with type 2 diabetes that was suboptimally controlled with TZD therapy.