Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P)
Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P)
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DOI：
10.1111/dom.12121
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发表时间：
2013-11-01
影响因子：
5.8
通讯作者：
Aronson, R.
中科院分区：
文献类型：
--
作者：
Pinget, M.;Goldenberg, R.;Aronson, R.
目的比较吡格列单二甲双胍控制不足的2型糖尿病患者每日一次餐用利昔那肽与安慰剂的疗效和安全性。方法随机双盲研究包括24周的主治疗期和52周的可变延长期。患者按2:1随机分配，接受利昔那肽20 μ g，每日一次或安慰剂。主要终点是第24周糖化血红蛋白（HbA1c）的变化。结果共纳入484例患者：利昔那肽组323例；161比安慰剂。24周后，利昔那肽每日1次显著改善HbA1c(与安慰剂相比-0.56%
AimsTo compare the efficacy and safety of once-daily prandial lixisenatide with placebo in type 2 diabetes mellitus (T2DM) insufficiently controlled by pioglitazonemetformin.MethodsThis randomized, double-blind study included a 24-week main treatment period and a 52-week variable extension period. Patients were randomized 2:1 to receive lixisenatide 20 mu g once daily or placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) at week 24.ResultsIn total, 484 patients were randomized: 323 to lixisenatide; 161 to placebo. After 24weeks, lixisenatide once daily significantly improved HbA1c (-0.56% vs. placebo; p