Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial
Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial
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DOI：
10.2337/dc16-1495
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发表时间：
2016-11-01
期刊：
影响因子：
16.2
通讯作者：
Bergenstal, Richard M.
中科院分区：
文献类型：
--
作者：
Aroda, Vanita R.;Rosenstock, Julio;Bergenstal, Richard M.
结论：本研究旨在证明利喜兰的有效性和安全性（iGlarLixi），一种新型、可滴定、固定比例的甘精胰岛素（iGlar）复方制剂（100单位）和利司那肽，与iGlar相比，在基础胰岛素联合或不联合最多两种口服降糖药控制不佳的2型糖尿病患者中，736例接受基础胰岛素治疗的患者（平均糖尿病病程12年，BMI 31 kg/m2）以1：1的比例随机接受开放标签、每日一次iGlarLixi或iGlar治疗，均滴定至空腹血糖水平
OBJECTIVEThis study was conducted to demonstrate the efficacy and safety of LixiLan (iGlarLixi), a novel, titratable, fixed-ratio combination of insulin glargine (iGlar) (100 units) and lixisenatide, compared with iGlar in patients with type 2 diabetes inadequately controlled on basal insulin with or without up to two oral glucose lowering agents.RESEARCH DESIGN AND METHODSAfter a 6-week run-in when iGlar was introduced and/or further titrated, and oral antidiabetic drugs other than metformin were stopped, 736 basal insulin-treated patients (mean diabetes duration 12 years, BMI 31 kg/m(2)) were randomized 1:1 to open-label, once-daily iGlarLixi or iGlar, both titrated to fasting plasma glucose