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

Naresh Aggarwal*, Anuj Singla, Chantal Mathieu, Eduard Montanya, Andreas F.H. Pfeiffer, Eva Johnsson, June Zhao, Nayyar Iqbal, Clifford Bailey

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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 2000mg or twice-daily metformin IR 1000mg for 24weeks. The primary endpoint was change in HbA1c after 24weeks. Secondary endpoints were change in fasting plasma glucose (FPG), mean daily glucose (MDG) and patients (%) with HbA1c <7.0% after 24weeks. 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 24weeks were similar for XR and IR: -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); 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 24weeks, with the advantage of once-daily dosing.

Original languageEnglish
Pages (from-to)463-467
JournalDiabetes, Obesity and Metabolism
Volume20
Issue number2
Early online date2 Oct 2017
DOIs
Publication statusPublished - 1 Feb 2018

Bibliographical note

© 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

Funding: AstraZeneca.

Keywords

  • Glycated haemoglobin
  • Metformin extended-release
  • Once-daily dosing
  • Randomized clinical trial
  • Type 2 diabetes

Fingerprint Dive into the research topics of 'Metformin extended-release versus immediate-release: An international, randomized, double-blind, head-to-head trial in pharmacotherapy-naïve patients with type 2 diabetes'. Together they form a unique fingerprint.

Cite this