Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes
Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes
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DOI：
10.1185/03007991003672551
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发表时间：
2010-05-01
影响因子：
2.3
通讯作者：
Kaku, K.
中科院分区：
文献类型：
--
作者：
Seino, Y.;Rasmussen, M. F.;Kaku, K.
目的：利拉鲁肽是一种每日一次的人胰高血糖素样肽-1 （GLP-1）类似物，用于治疗2型糖尿病（T2DM）。在2期和3期试验中，利拉鲁肽主要在欧洲血统人群中进行，已被证明可以降低HbA（1C）、体重和收缩压，同时降低低血糖的风险。这项为期24周的3期、多中心、双盲、双虚拟、随机平行组试验比较了利拉鲁肽和格列本脲单药治疗日本T2DM患者的疗效和安全性，这些患者未充分控制饮食治疗或口服降糖药（OAD）单药治疗。研究设计和方法：共有411名日本受试者被2:1随机分配到利拉鲁肽组（n=272）或格列本脲组（n=139）。利拉鲁肽的最大计划剂量为0.9 mg，每日一次。格列本脲每日一次或两次，计划最大剂量为2.5 mg/天，餐前或餐后给药。临床试验注册：NCT00393718。结果：24周后，利拉鲁肽的血糖控制不低于/优于格列本脲，24周时的HbA（1C）为利拉鲁肽的6.99% (SE +/- 0.07)，格列本脲的7.50% (SE +/- 0.09)(差异为-0.5%;95% CI -0.70 ~ 0.30
Objective:Liraglutide is a once-daily human glucagon-like peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes mellitus (T2DM). In Phase 2 and Phase 3 trials, largely conducted in populations of European descent, liraglutide has been shown to lower HbA(1C), weight and systolic blood pressure with a low risk of hypoglycaemia. This Phase 3, 24-week, multi-centre, double-blind, double dummy, randomised parallel-group trial compared the efficacy and safety of liraglutide and glibenclamide monotherapy in Japanese subjects with T2DM, inadequately controlled with diet therapy or oral antidiabetic drug (OAD) monotherapy.Research design and methods:A total of 411 Japanese subjects were randomised 2: 1 to liraglutide (n=272) or glibenclamide (n=139). Liraglutide was administered at a maximum planned dose of 0.9 mg once daily. Glibenclamide was administered once or twice daily at a planned maximum dose of 2.5 mg/day, before or after meals.Clinical trial registration:NCT00393718.Results:After 24 weeks, glycaemic control with liraglutide was non-inferior/superior to glibenclamide, with HbA(1C) at 24 weeks of 6.99% (SE +/- 0.07) with liraglutide and 7.50% (+/- 0.09) with glibenclamide (difference, -0.5%; 95% CI -0.70 to 0.30; p