Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes
Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes
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DOI：
10.1111/j.1463-1326.2006.00602.x
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发表时间：
2006-07-01
影响因子：
5.8
通讯作者：
Kendall, D. M.
中科院分区：
文献类型：
--
作者：
Blonde, L.;Klein, E. J.;Kendall, D. M.
目的：艾塞那肽，一种用于辅助治疗2型糖尿病（DM 2）的肠促胰岛素模拟物，在30周安慰剂对照试验中降低A1 C和体重。该分析检查了艾塞那肽对磺脲类药物（SU）和/或二甲双胍（MET）不能充分控制血糖的DM 2患者在82周内血糖控制和体重的影响。方法：这项中期分析包括314名在30周安慰剂对照试验中接受艾塞那肽治疗的患者，随后在52周开放试验中接受艾塞那肽治疗的患者。标签非对照扩展研究，共82周艾塞那肽。结果：患者完成了82周的艾塞那肽治疗[n = 314，63%男性，年龄56 ± 10岁，体重99 ± 21 kg，体重指数34 ± 6 kg/m2，A1 C 8.3 ± 1.0%（平均值± SD）]。A1 C自基线至第30周的降低[-0.9 +/- 0.1%（平均值+/- SE）]持续至第82周（-1.1 +/- 0.1%），48%的患者达到A1 C
Aim: Exenatide, an incretin mimetic for the adjunct treatment of type 2 diabetes (DM2), reduced A1C and weight in 30-week placebo-controlled trials. This analysis examined the effects of exenatide on glycaemic control and weight over an 82-week period in patients with DM2 unable to achieve adequate glycaemic control with sulphonylurea (SU) and/or metformin (MET).Methods: This interim analysis is of 314 patients who received exenatide in the 30-week placebo-controlled trials and subsequently in 52 weeks of open-label uncontrolled extension studies for 82 weeks of exenatide in total. Patients continued their SU and/or MET regimens throughout.Results: Patients completed 82 weeks of exenatide treatment [n = 314, 63% M, age 56 +/- 10 years, weight 99 +/- 21 kg, body mass index 34 +/- 6 kg/m(2), A1C 8.3 +/- 1.0% (mean +/- SD)]. Reduction in A1C from baseline to week 30 [-0.9 +/- 0.1% (mean +/- SE)] was sustained to week 82 (-1.1 +/- 0.1%), with 48% of patients achieving A1C