Efficacy and safety of repaglinide vs nateglinide for treatment of Japanese patients with type 2 diabetes mellitus

Abstract

Aims/Introduction: Repaglinide is a short-acting insulin secretagogue. We assessed the efficacy and safety of repaglinide in comparison with nateglinide in Japanese patients with type 2 diabetes previously treated with diet and exercise. Materials and Methods: In this 16-week randomized, multicenter, double-blind, parallel-group, active-controlled superiority trial, Japanese patients with type 2 diabetes and glycated hemoglobin (HbA 1c) of ≥6.9 and ≤9.4% were enrolled. Patients were randomly assigned to receive 0.5mg repaglinide (n=64) or 90mg nateglinide (n=66) three times a day. The primary end-point was changes in HbA 1c from baseline to the end of treatment. Results: Mean reductions of HbA 1c were significantly greater for the repaglinide group than the nateglinide group (-1.17±0.62 vs -0.81±0.39%, P<0.001). The target HbA 1c values of <6.9% were achieved by 75.0% of the repaglinide group vs 59.1% for nateglinide. Mean changes in fasting plasma glucose also showed significantly greater efficacy for repaglinide than nateglinide (-26.0±20.9 vs -18.3±17.8mg/dL, P<0.001). There were no differences in the adverse event rates between the repaglinide and the nateglinide group, by 57.8% (37/64) and 60.6% (40/66), respectively. Incidences of hypoglycemic symptoms were 17.2% (11/64, 28 events) in the repaglinide group and 6.1% (4/66, 20 events) in the nateglinide group, respectively. Conclusions: In type 2 diabetic patients treated with diet and exercise, repaglinide monotherapy gives greater glycemic improvement than nateglinide monotherapy in reducing HbA 1c and fasting plasma glucose values after 16weeks. This trial was registered with JapicCTI (no. JapicCTI-080521). © 2011 Asian Association for the Study of Diabetes and Blackwell Publishing Asia Pty Ltd.