EFFICACY AND TOLERABILITY OF MIGLITOL IN THE TREATMENT OF PATIENTS WITH NON-INSULIN-DEPENDENT DIABETES-MELLITUS

The efficacy of miglitol in improving postprandial glucose levels and its relationship to carbohydrate metabolism and absorption has been sh own in several in vivo and in vitro studies. A multicenter (10 centers ), randomized, double-blind, parallel-group study was designed to eval uate long-term efficacy and tolerability of miglitol versus placebo in patients with non-insulin dependent diabetes mellitus (NIDDM), A tota l of 102 patients were recruited and randomized (89 assessable patient s); after a run-in placebo period of 4 weeks, patients received miglit ol or placebo 100 mg thrice daily for 18 weeks. Fasting blood glucose, cholesterol, and triglyceride levels were determined every 6 weeks; g lycosylated hemoglobin HbA(1c) levels were determined at the beginning and at the end of the study. No significant differences appeared in b aseline values of efficacy variables. The primary efficacy analysis sh owed that miglitol was significantly more effective in reducing HbA(1c ) levels than placebo (P = 0.0158). Miglitol was also significantly mo re effective in reducing fasting blood glucose levels (P = 0.0012). No statistically significant differences were found in cholesterol or tr iglyceride levels. Meteorism, diarrhea, and flatulence were the most c ommon adverse events and occurred more frequently in the miglitol grou p (49.0% of miglitol patients vs 36.7% of placebo patients). Hypoglyce mic episodes occurred in 7 patients (2 in the miglitol group and 5 in the placebo group). Miglitol appears to be useful in the treatment of patients with NIDDM as it significantly reduces HbA(1c) and fasting bl ood glucose levels.