薬理と治療

Abstract

Objective Followed by a placebo-controlled, randomized, double-blind clinical trial, an open-label clinical trial was conducted to examine the long-term efficacy and safety of concomitantly administering mitiglinide（Glufast tablets）to type 2 diabetes mellitus patients without adequate glycemic control, despite receiving long-acting insulin only or a combination of long-acting insulin and an oral hypoglycemic agent with diet therapy. Methods During the double-blind clinical trial period, in addition to monotherapy with long-acting insulin or a combination therapy of long-acting insulin and an oral hypoglycemic agent, one tablet of mitiglinide（10 mg）or placebo was administered three times a day before meals for 16 weeks. During the open-label clinical trial period, in addition to insulin therapy for the double-blind clinical trial period, one tablet of mitiglinide（10 mg）was administered three times a day before meals for 36 weeks. This trial was registered in Clinical-Trials. gov （NCT02154347）．Results A significant decrease in HbA1c level from baseline was observed at any evaluation point after the initiation of treatment with mitiglinide. Adverse drug reactions to mitiglinide were observed in 31 out of 175 patients. Hypoglycemia occurred in 25 patients; however, severe hypoglycemia and treatment discontinuation case were not observed. Conclusions Mitiglinide appears to be clinically useful as a combination therapy with long-acting insulin in patients with type 2 diabetes mellitus.