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Metformin extended-release versus immediate-release: An international, randomized, double-blind, head-to-head trial in pharmacotherapy-naive patients with type 2 diabetes.


ABSTRACT: 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.

SUBMITTER: Aggarwal N 

PROVIDER: S-EPMC5813139 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Metformin extended-release versus immediate-release: An international, randomized, double-blind, head-to-head trial in pharmacotherapy-naïve patients with type 2 diabetes.

Aggarwal Naresh N   Singla Anuj A   Mathieu Chantal C   Montanya Eduard E   Pfeiffer Andreas F H AFH   Johnsson Eva E   Zhao June J   Iqbal Nayyar N   Bailey Clifford C  

Diabetes, obesity & metabolism 20171002 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 wer  ...[more]

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