Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono).
Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono).
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DOI：
10.2337/dc11-1935
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发表时间：
2012-06
期刊：
影响因子：
16.2
通讯作者：
EFC6018 GetGoal-Mono Study Investigators
中科院分区：
文献类型：
--
作者：
Fonseca VA;Alvarado-Ruiz R;Raccah D;Boka G;Miossec P;Gerich JE;EFC6018 GetGoal-Mono Study Investigators
评估利司那肽单药治疗2型糖尿病的疗效和安全性。361例未接受降糖治疗患者的随机、双盲、12周研究（HbA 1c 7-10%）分配至4种每日一次皮下给药剂量增加方案之一：利司那肽2步（10 μg持续1周，15 μg持续1周，然后20 μg; n = 120），利司那肽1步（10 μg持续2周，然后20 μg; n = 119）、安慰剂2步（n = 61）或安慰剂1步（n = 61）（合并安慰剂组进行分析）。主要终点为HbA 1c从基线至第12周的变化。利司那肽每日一次给药显著改善了两组的HbA 1c（基线平均值8.0%）（与安慰剂相比，最小二乘平均变化：2步为−0.54%，1步为−0.66%; P < 0.0001）。利司那肽组达到HbA 1c <7.0%（52.2% 2步，46.5% 1步）和≤6.5%（31.9% 2步，25.4% 1步）的患者显著多于安慰剂组（分别为26.8%和12.5%; P < 0.01）。利拉鲁肽导致餐后2小时血糖水平和标准化早餐试验期间测量的血糖波动显著改善。与安慰剂相比，在两个利司那肽组中均观察到空腹血糖显著降低。在所有组中均观察到体重平均下降（<102 kg）。最常见的不良事件为胃肠道-恶心是最常见的（利司那肽总体为23%，安慰剂为4.1%）。利司那肽组1.7%和安慰剂组1.6%的患者发生症状性低血糖，无重度发作。两种给药方案的安全性/耐受性相似。每日一次利司那肽单药治疗显著改善血糖控制，具有显著的餐后效应（血糖波动降低75%），在2型糖尿病患者中安全且耐受性良好。
To assess efficacy and safety of lixisenatide monotherapy in type 2 diabetes. Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy (HbA1c 7–10%) allocated to one of four once-daily subcutaneous dose increase regimens: lixisenatide 2-step (10 μg for 1 week, 15 μg for 1 week, and then 20 μg; n = 120), lixisenatide 1-step (10 μg for 2 weeks and then 20 μg; n = 119), placebo 2-step (n = 61), or placebo 1-step (n = 61) (placebo groups were combined for analyses). Primary end point was HbA1c change from baseline to week 12. Once-daily lixisenatide significantly improved HbA1c (mean baseline 8.0%) in both groups (least squares mean change vs. placebo: −0.54% for 2-step, −0.66% for 1-step; P < 0.0001). Significantly more lixisenatide patients achieved HbA1c <7.0% (52.2% 2-step, 46.5% 1-step) and ≤6.5% (31.9% 2-step, 25.4% 1-step) versus placebo (26.8% and 12.5%, respectively; P < 0.01). Lixisenatide led to marked significant improvements of 2-h postprandial glucose levels and blood glucose excursions measured during a standardized breakfast test. A significant decrease in fasting plasma glucose was observed in both lixisenatide groups versus placebo. Mean decreases in body weight (∼2 kg) were observed in all groups. The most common adverse events were gastrointestinal—nausea was the most frequent (lixisenatide 23% overall, placebo 4.1%). Symptomatic hypoglycemia occurred in 1.7% of lixisenatide and 1.6% of placebo patients, with no severe episodes. Safety/tolerability was similar for the two dose regimens. Once-daily lixisenatide monotherapy significantly improved glycemic control with a pronounced postprandial effect (75% reduction in glucose excursion) and was safe and well tolerated in type 2 diabetes.
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DOI：
10.1016/j.beem.2009.03.008
发表时间：
2009-08-01
影响因子：
7.4
作者：
Madsbad, Sten
通讯作者：
Madsbad, Sten
DOI：
10.1111/j.1464-5491.2008.02565.x
发表时间：
2008-10
期刊：
Diabetic medicine : a journal of the British Diabetic Association
影响因子：
--
作者：
Ceriello A;Colagiuri S
通讯作者：
Colagiuri S
影响因子：
16.2
作者：
Nathan DM;Buse JB;Davidson MB;Ferrannini E;Holman RR;Sherwin R;Zinman B;American Diabetes Association;European Association for Study of Diabetes
通讯作者：
European Association for Study of Diabetes
DOI：
10.1111/j.1464-5491.2010.03020.x
发表时间：
2010-09
期刊：
Diabetic medicine : a journal of the British Diabetic Association
影响因子：
--
作者：
Ratner RE;Rosenstock J;Boka G;DRI6012 Study Investigators
通讯作者：
DRI6012 Study Investigators
影响因子：
16.2
作者：
Monnier, L;Colette, C;Boniface, H
通讯作者：
Boniface, H