Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial.
Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial.
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DOI：
10.1111/dom.12539
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发表时间：
2015-11
期刊：
影响因子：
--
通讯作者：
NN2211-3917 Study Group
中科院分区：
文献类型：
--
作者：
Ahmann A;Rodbard HW;Rosenstock J;Lahtela JT;de Loredo L;Tornøe K;Boopalan A;Nauck MA;NN2211-3917 Study Group
在血糖控制不佳的2型糖尿病成人患者[糖化血红蛋白（HbA 1c）7.0-10.0%（53-86 mmol/mol）]中，确认在既存基础胰岛素类似物±二甲双胍基础上添加利拉鲁肽与安慰剂相比的优效性。在这项在诊所或医院进行的26周、双盲、平行组研究中，451例受试者以1：1的比例随机接受利拉鲁肽1.8 mg每日一次治疗（剂量分别从0.6和1.2 mg/天递增，各持续1周; n = 226）或安慰剂（n = 225）加至其既存基础胰岛素类似物（≥20 U/天）±二甲双胍（≥1500 mg/天）。随机化后，不允许将胰岛素调整至高于研究前剂量。主要终点为HbA 1c变化。26周后，利拉鲁肽组HbA 1c下降幅度[-1.3%（-14.2 mmol/mol）]大于安慰剂组[-0.1%（-1.2 mmol/mol）; p < 0.0001]。更多接受利拉鲁肽治疗的受试者达到HbA 1c目标：<7.0%（59% vs 14%; p < 0.0001）和≤6.5%（43% vs 4%; p < 0.0001），使用略少的胰岛素（35.8 IU vs 40.1 IU）。空腹血糖（−1.3 mmol/l）、7点血糖曲线（− 1.6 mmol/l）、体重（−3.1 kg）和收缩压（−5.0 mmHg）较基线的降幅更大（与安慰剂相比的估计治疗差异; p < 0.0001）。利拉鲁肽组的一过性胃肠道不良事件（恶心：22.2% vs 3.1%）和轻度低血糖（18.2% vs 12.4%）的发生率高于安慰剂组，与安慰剂组相比，脉搏增加（4.5次/分钟）。未发生重度低血糖或胰腺炎。与安慰剂相比，在基础胰岛素类似物±二甲双胍中添加利拉鲁肽可显著改善血糖控制、体重和收缩压。利拉鲁肽组的典型胃肠道症状和轻微低血糖发生率更高。
To confirm the superiority, compared with placebo, of adding liraglutide to pre‐existing basal insulin analogue ± metformin in adults with inadequately controlled type 2 diabetes [glycated haemoglobin (HbA1c) 7.0–10.0% (53–86 mmol/mol)]. In this 26‐week, double‐blind, parallel‐group study, conducted in clinics or hospitals, 451 subjects were randomized 1 : 1 to once‐daily liraglutide 1.8 mg (dose escalated from 0.6 and 1.2 mg/day, respectively, for 1 week each; n = 226) or placebo (n = 225) added to their pre‐existing basal insulin analogue (≥20 U/day) ± metformin (≥1500 mg/day). After randomization, insulin adjustments above the pre‐study dose were not allowed. The primary endpoint was HbA1c change. After 26 weeks, HbA1c decreased more with liraglutide [−1.3% (−14.2 mmol/mol)] than with placebo [−0.1% (−1.2 mmol/mol); p < 0.0001]. More subjects on liraglutide reached HbA1c targets: <7.0% (59% vs 14%; p < 0.0001) and ≤6.5% (43% vs 4%; p < 0.0001) using slightly less insulin (35.8 IU vs 40.1 IU). Greater decreases from baseline (estimated treatment differences vs placebo; p < 0.0001) occurred in fasting plasma glucose (−1.3 mmol/l), seven‐point glucose profiles (−1.6 mmol/l), body weight (−3.1 kg) and systolic blood pressure (−5.0 mmHg). Transient gastrointestinal adverse events (nausea: 22.2% vs 3.1%) and minor hypoglycaemia (18.2% vs 12.4%) were more frequent with liraglutide than placebo, and pulse increased (4.5 beats/min) compared with placebo. No severe hypoglycaemia or pancreatitis occurred. Adding liraglutide to a basal insulin analogue ± metformin significantly improved glycaemic control, body weight and systolic blood pressure compared with placebo. Typical gastrointestinal symptoms and minor hypoglycaemia were more frequent with liraglutide.
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