Effects of fixed-dose mitiglinide/voglibose combination on vascular endothelial function and glycemic variability in patients with type 2 diabetes: A randomized controlled trial

This multicenter, open-label, randomized, crossover study compared the effects of fixed-dose mitiglinide/voglibose combination tablet with glimepiride on vascular endothelial function and glycemic variability in 30 patients with type 2 diabetes mellitus. Patients received either mitiglinide/voglibose (three times daily administration of 10 mg mitiglinide and 0.2 mg voglibose) or glimepiride (once-daily 2 mg) in random order, for 5 days (n = 15/group). Reactive hyperemia index (RHI) and mean amplitude of glycemic excursions (MAGE) were measured as co-primary endpoints using reactive hyperemia peripheral arterial tonometry and continuous glucose monitoring. Although no significant difference was observed in RHI, MAGE was significantly lower in the mitiglinide/voglibose group (47.6 ± 18.5 mg/dL) than in the glimepiride group (100.6 ± 32.2 mg/dL). Compared to glimepiride, the use of mitiglinide/voglibose was associated with lower standard deviation of mean glucose, coefficient of variation and mean postprandial glucose excursion. Time below range (< 70 mg/dL) and time above range (> 180, > 200, and 250 mg/dL) were lower in the mitiglinide/voglibose group, while time in range (70–180 mg/dL) was higher. Although not impacting vascular endothelial function, mitiglinide/voglibose demonstrated potential benefits in reducing glycemic variability, postprandial hyperglycemia and hypoglycemia in patients with type 2 diabetes.