Mitiglinide/voglibose fixed-dose combination improves postprandial glycemic excursions in Japanese patients with type 2 diabetes mellitus.

OBJECTIVE: We examined the effects of a fixed-dose combination of 10 mg mitiglinide and 0.2 mg voglibose on postprandial glycemic excursions in Japanese type 2 diabetes mellitus (T2DM) patients. RESEARCH DESIGN AND METHODS: After a 2-week baseline period, 11 T2DM patients were treated with mitiglinide alone for 2 weeks and with the mitiglinide/voglibose combination for 6 weeks. MAIN OUTCOME MEASURES: Self-monitoring of blood glucose (SMBG) at home before and after unified meals, metabolic parameters during meal tolerance tests, and overall glycemic control parameters. RESULTS: Postprandial glycemic excursions after all three meals, as assessed by SMBG, were significantly lower in the combination period than in the baseline period, and after lunch and dinner in the combination period than in the mitiglinide period. The meal tolerance test confirmed that the magnitude of postprandial hyperglycemia was significantly lower, with significantly greater early-phase serum insulin secretion and sustained GLP-1 production, in the combination period compared with the baseline period. Overall glycemic control parameters also improved significantly in the combination period compared with the baseline period. These profiles suggest the combination is superior to mitiglinide alone, and may spare insulin secretion. CONCLUSION: The mitiglinide/voglibose combination significantly reduced postprandial glycemic excursions in Japanese T2DM patients. This trial was registered with the University Hospital Medical Information Network clinical trials database (no. UMIN000007202).