A RANDOMIZED PLACEBO-CONTROLLED TRIAL OF REPAGLINIDE IN THE TREATMENTOF TYPE-2 DIABETES

OBJECTIVE - The objective of the study was to assess the efficacy and safety of repaglinide compared with placebo in the treatment of patien ts with type 2 diabetes. RESEARCH DESIGN AND METHODS - This was a phas e II multicenter, double-blind, placebo-controlled, randomized, dose-a djustment and maintenance trial. After screening and a 2-week washout period, 99 patients were randomized to receive either repaglinide (n = 66) or placebo (n = 33). Patients underwent 6 weeks of dose adjustmen t followed by 12 weeks of dose maintenance. Fasting and stimulated gly cosylated hemoglobin (HbA(1c)), plasma glucose, insulin, and C-peptide were measured at predetermined intervals. Adverse events and hypoglyc emic episodes were recorded. RESULTS - From baseline to last visit, me an HbA(1c) decreased from 8.5 to 7.8% in patients treated with repagli nide and increased from 8.1 to 9.3% in patients receiving placebo, wit h a statistically significant difference of - 1.7% (P < 0.0001) betwee n treatment groups at the last visit Mean fasting plasma glucose and p ostprandial glucose increased in patients receiving placebo and decrea sed in patients treated with repaglinide, with statistically significa nt (P < 0.01) differences between groups at the last visit. Concentrat ions of fasting and postprandial insulin and C-peptide were lower at t he last visit compared with baseline for patients treated with placebo and higher for patients treated with repaglinide, and the differences between groups were statistically significant (P < 0.05). Overall, re paglinide was well tolerated. CONCLUSIONS - This study demonstrated th at repaglinide was safe and efficacious in lowering blood glucose conc entrations. In addition to overall improvement in glycemic control not ed with repaglinide in both sulfonylurea-treated patients and oral hyp oglycemic agent-naive patients, repaglinide had a potent glucose-lower ing effect in the postprandial period.