Effect of combination therapy with repaglinide and metformin hydrochloride on glycemic control in Japanese patients with type 2 diabetes mellitus

Journal of Diabetes Investigation

Ryuzo Kawamori⁵  Kohei Kaku¹  Toshiaki Hanafusa⁴  Tatsuya Oikawa³  Shigeru Kageyama² 

[1] Department of Medicine, Kawasaki Medical School, Okayama, Japan;Division of Clinical Pharmacology and Therapeutics, The Jikei University School of Medicine, Tokyo, Japan;Dainippon Sumitomo Pharma Co., Ltd, Osaka, Japan;Department of Internal Medicine (I), Osaka Medical College, Osaka, Japan;Sportology Center, Juntendo University Graduate School of Medicine, Supported by High Technology Research Center, Tokyo, Japan

关键词: Combination therapy;    Metformin;    Repaglinide;   

DOI  :  10.1111/jdi.12121

来源: Wiley

【 摘 要 】

Abstract

Aims/Introduction

We investigated the efficacy and safety of repaglinide as an add-on therapy for Japanese patients with type 2 diabetes mellitus receiving metformin monotherapy (at a dose of 1,500 mg/day, mainly) in addition to diet and exercise.

Materials and methods

In the 16-week multicenter, placebo-controlled, randomized, double-blind, parallel-group trial (the phase III study), patients with type 2 diabetes mellitus with metformin monotherapy were randomly assigned to the repaglinide or placebo group. Thereafter, a 36-week, multicenter, uncontrolled, dose-titration method study was extended to a total duration of 52 weeks (the long-term study). The primary end-point of each study was a change in glycated hemoglobin (HbA_1c) from baseline.

Results

After 16 weeks, mean reductions in HbA_1c were significantly greater for the repaglinide group than for the placebo group (–0.98 ± 0.72% vs 0.13 ± 0.63%, P < 0.001). In the long-term study, the mean change in HbA_1c was −0.76 ± 0.83%. The rate of adverse events was 60.6 and 50.0% in the repaglinide and placebo groups, respectively, in the phase III study, and 78.3% in the long-term study. Hypoglycemia was reported in 11.7, 0 and 13.3% of patients in the repaglinide group, placebo group and long-term study, respectively.

Conclusions

Combination therapy with repaglinide and metformin resulted in an approximately 1% reduction in HbA_1c at week 16 and in a significant long-term improvement in HbA_1c at the end of the study. No safety problems were noted during the concomitant use of repaglinide and metformin. These studies were registered with JapicCTI (nos. JapicCTI-101202 and JapicCTI-101203).

【 授权许可】

CC BY-NC-ND   
© 2013 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and Wiley Publishing Asia Pty Ltd

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