Efficacy and safety of glimepiride/metformin sustained release once daily vs. glimepiride/metformin twice daily in patients with type 2 diabetes

Abstract

Aims: The study investigated the clinical equivalence in reducing haemoglobin A1c (A1C) between glimepiride/metformin sustained release (GM-SR) 2/500mg, a fixed-dose combination, once daily and glimepiride/metformin (GM) 1/250mg, a fixed-dose combination, twice daily in patients with type 2 diabetes (T2D). Methods: A multicentre, randomised, double-blind, double-dummy study was conducted in 14 hospitals in Korea. Inclusion criteria were age 3075years, T2D diagnosis no longer than 10years previously, A1C between 7% and 10%, and body mass index <40kg/m2. A total of 207 subjects were randomised into the GM-SR group (n=101) or the GM group (n=106). Participants were assessed at baseline, 8weeks and 16weeks after treatment. Results: After 16weeks treatment, no difference in baseline-adjusted changes of A1C (primary efficacy variable) was observed between the two groups (0.59% for GM-SR group vs. 0.61% for GM group, 95% CI: 0.17 to 0.21; p=0.84). In addition, there were no significant differences in secondary efficacy parameters between the two groups, including changes in A1C up to week 8, changes in fasting plasma glucose (FPG) and 2-h-postprandial plasma glucose up to week 8 and week 16, response rate, drug compliance and hypoglycaemic events. However, there was a difference in baseline-adjusted changes of FPG between the two groups (1.01mmol/l for GM-SR group vs. 1.52mmol/l for GM group, p=0.01 in the intention to treat set). Conclusions: GM-SR 2/500mg once daily was as effective as GM 1/250mg twice daily in lowering A1C. In addition, no difference was noted in hypoglycaemic events between the two groups.