Evaluation of the efficacy and tolerability of miglitol in Chinese patients with type 2 diabetes mellitus inadequately controlled by diet and sulfonylureas

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

Treatment with Oral Drugs

Till the turn of the century, treatment of hyperglycemia in Type 2 diabetes was limited to two main classes of oral agents: sulfonylureas and biguanides. In the meantime, better understanding of the pathophysiology of hyperglycemia in Type 2 diabetes has been gained and the identification of several pathogenitic mechanisms has enabled moving from serendipitous discovery – as for sulfonylureas and metformin – to the development of agents with more targeted modes of action. Current guidelines concur in recommending metformin at diagnosis of diabetes. Selection of the second drug therapy should be made on the basis of an educated process tacking into consideration efficacy, risk of hypoglycemia, effect on body weight, costs of different drugs, as well as patient’s characteristics. With more clinical data generated, other features of the available oral agents should be taken into account such as durability, predominant effect on fasting vs. postprandial glucose, as well effects beyond their glucose lowering capacity