Affiliation:
1. First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan
2. Clinical Research Center, Hospital of the University of Occupational and Environmental Health, Japan
3. Wakamatsu Hospital of the University of Occupational and Environmental Health, Japan
Abstract
Abstract
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.
Publisher
Research Square Platform LLC