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- Title
Efficacy and safety of glimepiride/metformin sustained release once daily vs. glimepiride/metformin twice daily in patients with type 2 diabetes.
- Authors
Hwang, Y.‐C.; Kang, M.; Ahn, C. W.; Park, J. S.; Baik, S. H.; Chung, D. J.; Jang, H. C.; Kim, K.‐A.; Lee, I.‐K.; Min, K. W.; Nam, M.; Park, T. S.; Son, S. M.; Sung, Y.‐A.; Woo, J.‐T.; Park, K. S.; Lee, M.‐K.
- Abstract
Aims: The study investigated the clinical equivalence in reducing haemoglobin A1c (A1C) between glimepiride/metformin sustained release (GM-SR) 2/500 mg, a fixed-dose combination, once daily and glimepiride/metformin (GM) 1/250 mg, 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 30-75 years, T2D diagnosis no longer than 10 years previously, A1C between 7% and 10%, and body mass index < 40 kg/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, 8 weeks and 16 weeks after treatment. Results: After 16 weeks 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 (−1.01 mmol/l for GM-SR group vs. −1.52 mmol/l for GM group, p = 0.01 in the intention to treat set). Conclusions: GM-SR 2/500 mg once daily was as effective as GM 1/250 mg twice daily in lowering A1C. In addition, no difference was noted in hypoglycaemic events between the two groups.
- Publication
International Journal of Clinical Practice, 2013, Vol 67, Issue 3, p236
- ISSN
1368-5031
- Publication type
Article
- DOI
10.1111/ijcp.12071