Department of Endocrinology and Diabetes, HUS, Strasbourg, France.
Diabetes Obes Metab. 2013 Nov;15(11):1000-7. doi: 10.1111/dom.12121. Epub 2013 May 26.
To compare the efficacy and safety of once-daily prandial lixisenatide with placebo in type 2 diabetes mellitus (T2DM) insufficiently controlled by pioglitazone ± metformin.
This randomized, double-blind study included a 24-week main treatment period and a ≥52-week variable extension period. Patients were randomized 2 : 1 to receive lixisenatide 20 µg once daily or placebo. The primary endpoint was change in glycated haemoglobin (HbA1c) at week 24.
In total, 484 patients were randomized: 323 to lixisenatide; 161 to placebo. After 24 weeks, lixisenatide once daily significantly improved HbA1c (-0.56% vs. placebo; p < 0.0001) and increased the proportion of patients achieving HbA1c <7% compared with placebo (52.3% vs. 26.4%, respectively; p < 0.0001) and significantly improved fasting plasma glucose (-0.84 mmol/l vs. placebo; p < 0.0001). There was a small decrease in body weight with lixisenatide once daily and a small increase with placebo, with no statistically significant difference between the two groups. Overall, lixisenatide once daily was well tolerated, with a similar proportion of treatment-emergent adverse events (TEAEs) and serious TEAEs between groups (lixisenatide: 72.4% and 2.5%; placebo: 72.7% and 1.9%). Symptomatic hypoglycaemia rates were also relatively low in both groups (lixisenatide 3.4% and placebo 1.2%), with no severe episodes. Lixisenatide continued to be efficacious and well tolerated during the variable extension period.
Lixisenatide once daily significantly improved glycaemic control with a low risk of hypoglycaemia, and was well tolerated over 24 weeks and during the long-term, double-blind extension period in patients with T2DM insufficiently controlled on pioglitazone ± metformin.
比较每日一次餐前利西那肽与安慰剂在吡格列酮联合二甲双胍血糖控制不佳的 2 型糖尿病（T2DM）患者中的疗效和安全性。
这是一项随机、双盲研究，包括 24 周的主要治疗期和 52 周以上的可变扩展期。患者按 2:1 随机接受利西那肽 20μg 每日一次或安慰剂治疗。主要终点为 24 周时糖化血红蛋白（HbA1c）的变化。
共有 484 名患者被随机分组：323 名接受利西那肽治疗；161 名接受安慰剂治疗。24 周后，利西那肽每日一次显著改善 HbA1c（-0.56% vs. 安慰剂；p<0.0001），并增加了 HbA1c<7%的患者比例（分别为 52.3% vs. 26.4%；p<0.0001），空腹血糖也显著改善（-0.84mmol/l vs. 安慰剂；p<0.0001）。利西那肽每日一次治疗组体重略有下降，安慰剂组略有增加，但两组间无统计学差异。总体而言，利西那肽每日一次治疗耐受性良好，两组间治疗中出现的不良事件（TEAEs）和严重 TEAEs 的比例相似（利西那肽：72.4%和 2.5%；安慰剂：72.7%和 1.9%）。两组低血糖发生率也相对较低（利西那肽 3.4%和安慰剂 1.2%），且无严重病例。在可变扩展期，利西那肽仍保持疗效且耐受性良好。
利西那肽每日一次可显著改善血糖控制，低血糖风险低，在吡格列酮联合二甲双胍血糖控制不佳的 T2DM 患者中，24 周及长期双盲扩展期内耐受性良好。
