Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6)
Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6)
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DOI：
10.1016/s0140-6736(09)60659-0
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发表时间：
2009-07-04
期刊：
影响因子：
168.9
通讯作者：
Blonde, Lawrence
中科院分区：
文献类型：
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作者：
Buse, John B.;Rosenstock, Julio;Blonde, Lawrence
背景与大多数降血糖药物不同，胰升糖素样肽-1(GLP-1)受体激动剂具有葡萄糖依赖的作用，并促进体重减轻。我们比较了人类GLP-1类似物利拉鲁肽和以Exendin为基础的GLP-1受体激动剂Exenatide的疗效和安全性。方法根据既往口服降糖药物的最大耐受量，对控制不佳的2型糖尿病患者进行分层，在一项为期26周的开放标签、平行分组、多国(15个国家)的研究中，随机分配到额外服用利拉鲁肽1.8 mg/d(n=233)或exenatide 10 u/d(n=231)。主要结果是糖化血红蛋白(HbA(1c))的变化。疗效分析按意向处理。该试验在ClinicalTrials.gov注册，编号为NCT00518882。研究人群的平均基线HBA(1c)为8.2%。利拉鲁肽对HBA(1c)的平均降幅显著高于艾塞那肽(-1.12%[SE 0.08]vs-0.79%[0.08]；估计治疗差异-0.33；95%CI-0.47至-0.18；p
Background Unlike most antihyperglycaemic drugs, glucagon-like peptide-1 (GLP-1) receptor agonists have a glucose-dependent action and promote weight loss. We compared the efficacy and safety of liraglutide, a human GLP-1 analogue, with exenatide, an exendin-based GLP-1 receptor agonist.Methods Adults with inadequately controlled type 2 diabetes on maximally tolerated doses of metformin, sulphon urea, or both, were stratified by previous oral antidiabetic therapy and randomly assigned to receive additional liraglutide 1.8 mg once a day (n=233) or exenatide 10 mu g twice a day (n=231) in a 26-week open-label, parallel-group, multinational (15 countries) study. The primary outcome was change in glycosylated haemoglobin (HbA(1c)). Efficacy analyses were by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00518882.Findings Mean baseline HbA(1c) for the study population was 8.2%. Liraglutide reduced mean HbA(1c) significantly more than did exenatide (-1.12% [SE 0.08] vs -0.79% [0.08]; estimated treatment difference -0.33; 95% CI -0.47 to -0.18; p