AAA Clinical Research, Brampton, Ontario, Canada.
Department of Endocrinology, Katholieke Universiteit Leuven, Leuven, Belgium.
Diabetes Obes Metab. 2018 Feb;20(2):463-467. doi: 10.1111/dom.13104. Epub 2017 Oct 2.
This international, randomized, double-blind trial (NCT01864174) compared the efficacy and safety of metformin extended-release (XR) and immediate-release (IR) in patients with type 2 diabetes. After a 4-week placebo lead-in, pharmacotherapy-naïve adults with glycated haemoglobin (HbA1c) at 7.0% to 9.2% were randomized (1:1) to receive once-daily metformin XR 2000 mg or twice-daily metformin IR 1000 mg for 24 weeks. The primary endpoint was change in HbA1c after 24 weeks. Secondary endpoints were change in fasting plasma glucose (FPG), mean daily glucose (MDG) and patients (%) with HbA1c <7.0% after 24 weeks. Overall, 539 patients were randomized (metformin XR, N = 268; metformin IR, N = 271). Adjusted mean changes in HbA1c, FPG, MDG and patients (%) with HbA1c <7.0% after 24 weeks were similar for XR and IR: -0.93% vs -0.96%; -21.1 vs -20.6 mg/dL (-1.2 vs -1.1 mmol/L); -24.7 vs -27.1 mg/dL (-1.4 vs -1.5 mmol/L); and 70.9% vs 72.0%, respectively. Adverse events were similar between groups and consistent with previous studies. Overall, metformin XR demonstrated efficacy and safety similar to that of metformin IR over 24 weeks, with the advantage of once-daily dosing.
这项国际性、随机、双盲试验（NCT01864174）比较了二甲双胍缓释片（XR）和普通片（IR）在 2 型糖尿病患者中的疗效和安全性。经过 4 周的安慰剂导入期后，将糖化血红蛋白（HbA1c）为 7.0%至 9.2%的未经药物治疗的成年患者随机（1:1）分为每日一次服用二甲双胍 XR 2000mg 或每日两次服用二甲双胍 IR 1000mg，疗程 24 周。主要终点是 24 周时 HbA1c 的变化。次要终点是 24 周时空腹血糖（FPG）、平均每日血糖（MDG）和 HbA1c＜7.0%的患者比例的变化。共有 539 名患者被随机分组（二甲双胍 XR 组，N=268；二甲双胍 IR 组，N=271）。调整后的 HbA1c、FPG、MDG 和 HbA1c＜7.0%的患者比例在 XR 和 IR 组之间的变化相似：-0.93% vs -0.96%；-21.1 vs -20.6mg/dL（-1.2 vs -1.1mmol/L）；-24.7 vs -27.1mg/dL（-1.4 vs -1.5mmol/L）；70.9% vs 72.0%。两组间不良反应相似，与既往研究一致。总体而言，二甲双胍 XR 在 24 周时显示出与二甲双胍 IR 相似的疗效和安全性，具有每日一次给药的优势。
