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

被引：41

作者：

Jin, S-M ^{[1
]}

Park, C-Y ^{[2
]}

Cho, Y. M. ^{[3
]}

Ku, B. J. ^{[4
]}

Ahn, C. W. ^{[5
]}

Cha, B-S ^{[6
]}

Min, K. W. ^{[7
]}

Sung, Y. A. ^{[8
]}

Baik, S. H. ^{[9
]}

Lee, K. W. ^{[10
]}

Yoon, K-H ^{[11
]}

Lee, M-K ^{[1
]}

Park, S. W. ^{[2
]}

机构：

[1] Sungkyunkwan Univ, Sch Med, Samsung Med Ctr, Dept Med,Div Endocrinol & Metab, Seoul, South Korea

[2] Sungkyunkwan Univ, Sch Med, Kangbuk Samsung Hosp, Dept Endocrinol & Metab, Seoul, South Korea

[3] Seoul Natl Univ, Coll Med, Dept Internal Med, Seoul 151, South Korea

[4] Chungnam Natl Univ, Sch Med, Dept Internal Med, Taejon, South Korea

[5] Yonsei Univ, Coll Med, Gangnam Severance Hosp, Dept Internal Med, Seoul, South Korea

[6] Yonsei Univ, Coll Med, Dept Internal Med, Severance Hosp, Seoul, South Korea

[7] Eulji Univ, Sch Med, Dept Endocrinol & Metab, Diabet Ctr,Eulji Gen Hosp, Seoul, South Korea

[8] Ewha Womans Univ, Sch Med, Dept Internal Med, Seoul, South Korea

[9] Korea Univ, Coll Med, Dept Internal Med, Div Endocrinol & Metab, Seoul 136705, South Korea

[10] Ajou Univ, Sch Med, Dept Endocrinol & Metab, Suwon 441749, South Korea

[11] Catholic Univ Korea, Inst Med Sci, Dept Endocrinol & Metab, Immunol,Cell Biol Core Lab, Seoul, South Korea

来源：

DIABETES OBESITY & METABOLISM | 2015年 / 17卷 / 06期

关键词：

antidiabetic drug; clinical trial; phase III study; randomised trial; thiazolidinediones; GAMMA AGONIST; CKD-501; THIAZOLIDINEDIONE; PHARMACOKINETICS; RISK;

D O I：

10.1111/dom.12435

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 (15 mg, 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 week 24. At week 24, 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.

引用

页码：599 / 602

页数：4

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