Efficacy and safety of glimepiride/metformin sustained release once daily vs.
glimepiride/metformin twice daily in patients with type 2 diabetes.
Author(s): Hwang YC(1), Kang M, Ahn CW, Park JS, Baik SH, Chung DJ, Jang HC, Kim KA, Lee IK,
Min KW, Nam M, Park TS, Son SM, Sung YA, Woo JT, Park KS, Lee MK.
Affiliation(s): Author information:
(1)Division of Endocrinology and Metabolism, Department Internal Medicine, Kyung Hee
University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul,
Korea.
Publication date & source: 2013, Int J Clin Pract. , 67(3):236-43
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/m(2) . 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.
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