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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

Authors
 Y.-C. Hwang  ;  M. Kang  ;  C. W. Ahn  ;  J. S. Park  ;  S. H. Baik  ;  D. J. Chung  ;  H. C. Jang  ;  K.-A. Kim  ;  I.-K. Lee  ;  K. W. Min  ;  M. Nam  ;  T. S. Park  ;  S. M. Son  ;  Y.-A. Sung  ;  J.-T. Woo  ;  K. S. Park  ;  M.-K. Lee 
Citation
 INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Vol.67(3) : 236-243, 2013 
Journal Title
 INTERNATIONAL JOURNAL OF CLINICAL PRACTICE 
ISSN
 1368-5031 
Issue Date
2013
MeSH
Adult ; Aged ; Blood Glucose/metabolism ; Delayed-Action Preparations ; Diabetes Mellitus, Type 2/blood ; Diabetes Mellitus, Type 2/drug therapy* ; Double-Blind Method ; Drug Administration Schedule ; Female ; Glycated Hemoglobin A/metabolism ; Humans ; Hypoglycemic Agents/administration & dosage* ; Hypoglycemic Agents/adverse effects ; Male ; Medication Adherence ; Metformin/administration & dosage* ; Metformin/adverse effects ; Middle Aged ; Sulfonylurea Compounds/administration & dosage* ; Sulfonylurea Compounds/adverse effects ; Treatment Outcome
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/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.
Full Text
http://onlinelibrary.wiley.com/doi/10.1111/ijcp.12071/abstract
DOI
10.1111/ijcp.12071
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Jong Suk(박종숙) ORCID logo https://orcid.org/0000-0002-5385-1373
Ahn, Chul Woo(안철우) ORCID logo https://orcid.org/0000-0003-3733-7486
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/158514
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