The objective of this study is to examine the efficacy and tolerability of
miglitol with respect to improving
glycemic control in Chinese patients with
type 2 diabetes mellitus inadequately controlled by diet and sulfonylurea treatment. This was a randomized, double-blinded, placebo-controlled, multicenter study. A total of 105 patients were randomized to receive 24 weeks of treatment with
miglitol (n = 52; titrated from 50 mg to 100 mg 3 times daily) or placebo (n = 53). Concomitant sulfonylurea treatment and diet remained unchanged. The primary endpoint was change in
glycated hemoglobin (HbA1c) from baseline at 24 weeks. Secondary endpoints were changes in fasting plasma
glucose (FPG), postprandial plasma
glucose (PPG), and postprandial serum
insulin (PSI). The
miglitol treatment group showed significantly greater reductions in HbA1c and PPG levels compared with the placebo group. With respect to adverse events, abdominal discomfort,
diarrhea, and
hypoglycemia occurred with similar frequency in both groups. Results of this study indicate that
miglitol significantly improves metabolic control in Chinese patients with
type 2 diabetes mellitus.
Miglitol is safe and well tolerated, with the exception of abdominal discomfort. Therefore,
miglitol may be a useful adjuvant
therapy for Chinese patients with
type 2 diabetes mellitus inadequately controlled by diet and sulfonylurea treatment.