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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

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.
Ewha Authors
성연아
SCOPUS Author ID
성연아scopus
Issue Date
2013
Journal Title
International Journal of Clinical Practice
ISSN
1368-5031JCR Link
Citation
vol. 67, no. 3, pp. 236 - 243
Indexed
SCI; SCIE; SCOPUS WOS scopus
Abstract
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.
DOI
10.1111/ijcp.12071
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의과대학 > 의학과 > Journal papers
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