Repaglinide in type 2 diabetes: A 24-week, fixed-dose efficacy and safety study

In this 24-week multicenter, double-blind, randomized, fixed-dose trial, 36 1 patients having type 2 diabetes received daily preprandial treatment with placebo (n = 75), repaglinide 2 mg (n = 140), or repaglinide 4 mg (n = 146 ). By a last-observation carried-forward calculation, repaglinide I mg or 4 mg treatment decreased mean fasting plasma glucose (FPG) values (by -47 mg /dL or -49 mg/dL) while the placebo group had increased FPG values (by 19 m g/dL). For the repaglinide treatment groups at the end of the study, change s in HbA(1C) from baseline values ranged from 1.8 to 1.9 percentage points lower than the placebo group. There were no events of severe hypoglycemia. Nearly all hypoglycemic symptom episodes had blood glucose levels above 45 mg/dL. Repaglinide was well tolerated in a preprandial fixed-dose regimen o f 1 mg or 4 mg, assigned without adjustment for clinical parameters. (C) 20 00 the American College of Clinical Pharmacology.