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Randomized Controlled Trial Comparison of the Efficacy and Safety of Glimepiride/Metformin Fixed Combination Versus Free Combination in Patients with Type 2 Diabetes: Multicenter, Randomized, Controlled Trial.
Seung Hwan Lee, In Kyu Lee, Sei Hyun Baik, Dong Seop Choi, Kyong Soo Park, Ki Ho Song, Kwan Woo Lee, Bong Soo Cha, Chul Woo Ahn, Hyoung Woo Lee, Choon Hee Chung, Moon Suk Nam, Hong Sun Baek, Yong Ki Kim, Hyo Young Rhim, Ho Young Son
Diabetes & Metabolism Journal 2006;30(6):466-475
DOI: https://doi.org/10.4093/jkda.2006.30.6.466
Published online: November 1, 2006
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1Kangnam St. Mary's hospital,, The Catholic University of Korea, Korea.
2Keimyung University Medical Center, Korea.
3Korea University Guro Hospital, Korea.
4Korea University Anam Hospital, Korea.
5Seoul National University Hospital, Korea.
6St. Vincent Hospital, The Catholic University of Korea, Korea.
7Ajou University Hospital, Korea.
8Severance Hospital, Yonsei University, Korea.
9Yongdong Severance Hospital, Yonsei University, Korea.
10Yeongnam University Medical Center, Korea.
11Wonju Christian Hospital, Korea.
12Inha Universtiy Hospital, Korea.
13Chonbuk National University Hospital, Korea.
14Pusan National Universtiy Hospital, Korea.
15Handok Pharmaceuticals Co., LTD., Korea.

BACKGROUND
Failure to manage diabetes mellitus receiving monotherapy increases as the duration of the disease is protracted, and in many cases it becomes inevitable to introduce combined therapies. However, compliance of the patients tends to decrease. We conducted a clinical study to compare the efficacy and safety of preconstituted and fixed combination therapy of glimepiride plus metformin to those of free combination therapy. METHODS: Two hundred and thirteen patients with type 2 diabetes who had been diagnosed at least six months ago were randomly assigned either to a fixed group or a free group. The initial dosage was chosen according to the previous treatment history and then adjusted every two weeks following a predefined titration algorithm to meet the target mean fasting glucose levels (140 mg/dL). The medications were given for 16 weeks. The primary endpoint was the change in HbA1c level from baseline to week 16. Various parameters were checked as secondary outcome measures and safety criteria. RESULTS: HbA1c level of the fixed group and the free group decreased by 1.09% and 1.08%, respectively. The 95% CI of the changes' difference between the two groups (-0.21%, +0.19%) was within the predefined equivalence interval (-0.5%, +0.5%). Secondary outcome measures (the changes of fasting and postprandial plasma glucose level, response rate and compliance) and safety criteria (frequency of hypoglycemia and adverse reactions) were similar between the two groups. CONCLUSION: Fixed combination of glimepiride/metformin is as effective and safe therapy as free combination in type 2 diabetes patients.

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    Comparison of the Efficacy and Safety of Glimepiride/Metformin Fixed Combination Versus Free Combination in Patients with Type 2 Diabetes: Multicenter, Randomized, Controlled Trial.
    Korean Diabetes J. 2006;30(6):466-475.   Published online November 1, 2006
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