Lobeglitazone and pioglitazone as add-ons to metformin for patients with type 2 diabetes: a 24-week, multi-centre, randomized, double-blind, parallel-group, active-controlled, phase III clinical trial with a 28-week extension
Diabetes, Obesity and Metabolism, 01/12/2015 Clinical Article
Jin SM, et al. – The authors aimed to compare the efficacy and safety of lobeglitazone and pioglitazone as add–ons to metformin in patients with type 2 diabetes. Lobeglitazone was not inferior to pioglitazone as an add–on to metformin in terms of the efficacy and safety.
Methods
- 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 of lobeglitazone treatment in patients who consented.
Results
- The primary endpoint was the change in HbA1c level between baseline and week 24.
- At week 24, the mean change from baseline 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].
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