Lobeglitazone and pioglitazone as add-ons to metformin for patients with type 2 diabetes: A 24-week, multicentre, randomized, double-blind, parallel-group, active-controlled, phase III clinical trial with a 28-week extension

S. M. Jin, C. Y. Park, Y. M. Cho, B. J. Ku, C. W. Ahn, B. S. Cha, K. W. Min, Y. A. Sung, Sei-Hyun Baik, K. W. Lee, K. H. Yoon, M. K. Lee, S. W. Park

Research output: Contribution to journalLetter

21 Citations (Scopus)

Abstract

We aimed to compare the efficacy and safety of lobeglitazone and pioglitazone as add-ons to metformin in patients with type 2 diabetes. Patients who were inadequately controlled by metformin were randomized and treated once daily with either lobeglitazone (0.5mg, n=128) or pioglitazone (15mg, n=125) for 24weeks, with a 28-week extension trial of lobeglitazone treatment in patients who consented. The primary endpoint was the change in glycated haemoglobin (HbA1c) concentration from baseline to week24. At week24, the mean change from baseline in HbA1c was -0.74% for the lobeglitazone group and -0.74% for the pioglitazone group, with a mean difference of 0.01% [95% confidence interval (CI) of difference, -0.16 to 0.18]. The effects of lobeglitazone on lipid variables and the adverse events associated with lobeglitazone were similar to those observed with pioglitazone. Lobeglitazone was not inferior to pioglitazone as an add-on to metformin in terms of their efficacy and safety.

Original languageEnglish
Pages (from-to)599-602
Number of pages4
JournalDiabetes, Obesity and Metabolism
Volume17
Issue number6
DOIs
Publication statusPublished - 2015 Jan 1

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Keywords

  • Antidiabetic drug
  • Clinical trial
  • Phase III study
  • Randomised trial
  • Thiazolidinediones

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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