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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

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...

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Autores principales: Aggarwal, Naresh, Singla, Anuj, Mathieu, Chantal, Montanya, Eduard, Pfeiffer, Andreas F. H., Johnsson, Eva, Zhao, June, Iqbal, Nayyar, Bailey, Clifford
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5813139/
https://www.ncbi.nlm.nih.gov/pubmed/28857388
http://dx.doi.org/10.1111/dom.13104
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author Aggarwal, Naresh
Singla, Anuj
Mathieu, Chantal
Montanya, Eduard
Pfeiffer, Andreas F. H.
Johnsson, Eva
Zhao, June
Iqbal, Nayyar
Bailey, Clifford
author_facet Aggarwal, Naresh
Singla, Anuj
Mathieu, Chantal
Montanya, Eduard
Pfeiffer, Andreas F. H.
Johnsson, Eva
Zhao, June
Iqbal, Nayyar
Bailey, Clifford
author_sort Aggarwal, Naresh
collection PubMed
description 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.
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spelling pubmed-58131392018-02-21 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 Singla, Anuj Mathieu, Chantal Montanya, Eduard Pfeiffer, Andreas F. H. Johnsson, Eva Zhao, June Iqbal, Nayyar Bailey, Clifford Diabetes Obes Metab Brief Reports 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. Blackwell Publishing Ltd 2017-10-02 2018-02 /pmc/articles/PMC5813139/ /pubmed/28857388 http://dx.doi.org/10.1111/dom.13104 Text en © 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 (http://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Brief Reports
Aggarwal, Naresh
Singla, Anuj
Mathieu, Chantal
Montanya, Eduard
Pfeiffer, Andreas F. H.
Johnsson, Eva
Zhao, June
Iqbal, Nayyar
Bailey, Clifford
Metformin extended‐release versus immediate‐release: An international, randomized, double‐blind, head‐to‐head trial in pharmacotherapy‐naïve patients with type 2 diabetes
title Metformin extended‐release versus immediate‐release: An international, randomized, double‐blind, head‐to‐head trial in pharmacotherapy‐naïve patients with type 2 diabetes
title_full Metformin extended‐release versus immediate‐release: An international, randomized, double‐blind, head‐to‐head trial in pharmacotherapy‐naïve patients with type 2 diabetes
title_fullStr Metformin extended‐release versus immediate‐release: An international, randomized, double‐blind, head‐to‐head trial in pharmacotherapy‐naïve patients with type 2 diabetes
title_full_unstemmed Metformin extended‐release versus immediate‐release: An international, randomized, double‐blind, head‐to‐head trial in pharmacotherapy‐naïve patients with type 2 diabetes
title_short Metformin extended‐release versus immediate‐release: An international, randomized, double‐blind, head‐to‐head trial in pharmacotherapy‐naïve patients with type 2 diabetes
title_sort metformin extended‐release versus immediate‐release: an international, randomized, double‐blind, head‐to‐head trial in pharmacotherapy‐naïve patients with type 2 diabetes
topic Brief Reports
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5813139/
https://www.ncbi.nlm.nih.gov/pubmed/28857388
http://dx.doi.org/10.1111/dom.13104
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