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

18 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

Fingerprint

pioglitazone
Phase III Clinical Trials
Metformin
Type 2 Diabetes Mellitus
Safety
Glycosylated Hemoglobin A
lobeglitazone

Keywords

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

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

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

In: Diabetes, Obesity and Metabolism, Vol. 17, No. 6, 01.01.2015, p. 599-602.

Research output: Contribution to journalLetter

Jin, S. M. ; Park, C. Y. ; Cho, Y. M. ; Ku, B. J. ; Ahn, C. W. ; Cha, B. S. ; Min, K. W. ; Sung, Y. A. ; Baik, Sei-Hyun ; Lee, K. W. ; Yoon, K. H. ; Lee, M. K. ; Park, S. W. / 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. In: Diabetes, Obesity and Metabolism. 2015 ; Vol. 17, No. 6. pp. 599-602.
@article{d2930281f569491897cbdd3e055bf00f,
title = "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",
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.",
keywords = "Antidiabetic drug, Clinical trial, Phase III study, Randomised trial, Thiazolidinediones",
author = "Jin, {S. M.} and Park, {C. Y.} and Cho, {Y. M.} and Ku, {B. J.} and Ahn, {C. W.} and Cha, {B. S.} and Min, {K. W.} and Sung, {Y. A.} and Sei-Hyun Baik and Lee, {K. W.} and Yoon, {K. H.} and Lee, {M. K.} and Park, {S. W.}",
year = "2015",
month = "1",
day = "1",
doi = "10.1111/dom.12435",
language = "English",
volume = "17",
pages = "599--602",
journal = "Diabetes, Obesity and Metabolism",
issn = "1462-8902",
publisher = "Wiley-Blackwell",
number = "6",

}

TY - JOUR

T1 - Lobeglitazone and pioglitazone as add-ons to metformin for patients with type 2 diabetes

T2 - A 24-week, multicentre, randomized, double-blind, parallel-group, active-controlled, phase III clinical trial with a 28-week extension

AU - Jin, S. M.

AU - Park, C. Y.

AU - Cho, Y. M.

AU - Ku, B. J.

AU - Ahn, C. W.

AU - Cha, B. S.

AU - Min, K. W.

AU - Sung, Y. A.

AU - Baik, Sei-Hyun

AU - Lee, K. W.

AU - Yoon, K. H.

AU - Lee, M. K.

AU - Park, S. W.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - 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.

AB - 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.

KW - Antidiabetic drug

KW - Clinical trial

KW - Phase III study

KW - Randomised trial

KW - Thiazolidinediones

UR - http://www.scopus.com/inward/record.url?scp=84928409354&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84928409354&partnerID=8YFLogxK

U2 - 10.1111/dom.12435

DO - 10.1111/dom.12435

M3 - Letter

VL - 17

SP - 599

EP - 602

JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

SN - 1462-8902

IS - 6

ER -