Comparison of Glycemic Excursion Using Flash Continuous Glucose Monitoring in Patients with Type 2 Diabetes Mellitus Before and After Treatment with Voglibose.

Purpose To determine the effect of Voglibose add-on therapy on daily glycemic excursions in Indian patients with type 2 diabetes(T2DM) receiving a stable dose of metformin(Met)or metformin+sulfonylurea(Met+SU). Patients and methods T2DM patients with glycosylated hemoglobin(HbA1c) >7.0% and at least two postprandial excursions>140 mg/dL during the screening phase(visit 1/day-14±2), were enrolled in this prospective, multi-centre interventional study. The patients were randomized at visit 2(Day 0±2) to receive Voglibose 0.2 mg or 0.3 mg tablets (BID/TID) as add-on therapy to Met and Met+SU. Patients were followed at Day 14±2 (visit 3), Month 3±14 days (visit 4),14 weeks(i.e.visit 4+14 days) ±2days(visit 5) and Month 6±14 days (visit 6). Continuous glucose monitoring was performed at visits 2, 3 and 5. The study outcomes were : change in average number of glycemic excursionsy,percent time spent in glucose fluctuations, mean postprandial glucose(PPG), fasting plasma glucose(FPG), day and night time mean glucose levels from baseline to day 14 and week 14; change in mean amplitude of glycemic excursion(MAGE) from baseline to 14 weeks; and mean HbA1c level at 3 and 6 months. Results Out of 110 patients enrolled, 101 patients(91.8%)(Met+SU+Voglibose:73 and Met+Voglibose:28) completed the study. There was a significant decrease in average number of glycemic excursions per day from baseline to day 14 in Met+Sul+Voglibose group and to week 14 in Met+Voglibose group.There was also a significant reduction in percent time spent above target glucose range from baseline to day 14 in both treatment groups.A significant reduction in mean PPG area under the curve and mean FPG levels from baseline to day 14 was reported in both treatment groups. MAGE also reduced from baseline to week 14. At 6 months, HbA1c was significantly lower, especially in the Met+SU+Voglibose arm. Conclusion Voglibose is useful in reducing glycemic variability and improving glycemic control in Asian Indian adults with T2DM.(CTRI/2018/04/013074).