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- 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.
- Authors
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, S. H.; Lee, K. W.; Yoon, K.‐H.; Lee, M.‐K.; Park, S. W.
- 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 (0.5 mg, n = 128) or pioglitazone (15 mg, n = 125) for 24 weeks, 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.
- Subjects
PEOPLE with diabetes; TYPE 2 diabetes treatment; PIOGLITAZONE; METFORMIN; DRUG efficacy; MEDICATION safety; CLINICAL drug trials; THERAPEUTICS
- Publication
Diabetes, Obesity & Metabolism, 2015, Vol 17, Issue 6, p599
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.12435