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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...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Blackwell Publishing Ltd
2017
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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. |
format | Online Article Text |
id | pubmed-5813139 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Blackwell Publishing Ltd |
record_format | MEDLINE/PubMed |
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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