Document Detail


Efficacy and safety of glimepiride/metformin sustained release once daily vs. glimepiride/metformin twice daily in patients with type 2 diabetes.
MedLine Citation:
PMID:  23336668     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.
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
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-22
Journal Detail:
Title:  International journal of clinical practice     Volume:  -     ISSN:  1742-1241     ISO Abbreviation:  Int. J. Clin. Pract.     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-22     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9712381     Medline TA:  Int J Clin Pract     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2013 Blackwell Publishing Ltd.
Affiliation:
Division of Endocrinology and Metabolism, Department Internal Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Korea Center for Health Promotion, Samsung Medical Center, Seoul, Korea Department of Internal Medicine, Yonsei University, Seoul, Korea Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea Department of Internal Medicine, Seoul National University, Bundang Hospital, Gyeonggi-Do, Korea Department of Internal Medicine, University of Dongguk College of Medicine, Dongguk University Ilsan Hospital, Goyang, Korea Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea Department of Internal Medicine, Eulji University College of Medicine, Daejeon, Korea Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea Division of Endocrinology & Metabolism, Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea Division of Endocrinology and Metabolism, Department of Internal Medicine, Pusan National University School of Medicine, Busan, Korea Division of Endocrinology, Department of Internal Medicine, Ewha Womans University College of Medicine, Seoul, Korea Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
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