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Efficacy and safety of glimepiride/metformin sustained release once daily vs. glimepiride/metformin twice daily in patients with type 2 diabetes
- Efficacy and safety of glimepiride/metformin sustained release once daily vs. glimepiride/metformin twice daily in patients with type 2 diabetes
- 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.
- Ewha Authors
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- International Journal of Clinical Practice
- International Journal of Clinical Practice vol. 67, no. 3, pp. 236 - 243
- SCIE; SCOPUS
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- Aim:s: 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. © 2013 Blackwell Publishing Ltd.
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