Prospective multicenter observational study of Voglibose in type 2 diabetes-Victory

Abstract

Objective: Despite its beneficial effect on postprandial hyperglycemia, the effect and usage of voglibose for the management of type 2 diabetes mellitus (T2DM) in routine clinical practice remains undetermined. The objective of this non-interventional study is to determine the real-world effectiveness of voglibose in terms of efficacy and safety, and the usage pattern as monotherapy or add-on treatment in patients with T2DM in India. Design: This was a 12-week, multi-center, prospective, observational study. Methods: Adults with inadequately controlled T2DM (glycated hemoglobin [HbA1c] 7.0-10.0% despite diet, exercise and/or antidiabetic agents), treated with voglibose monotherapy or as add-on therapy, were recruited from 39 sites. The primary endpoint was change in HbA1c. Secondary endpoints were change in fasting and postprandial blood glucose (FBG and PPBG) levels and bodyweight, pattern of usage and safety assessments. Mean change in HbA1c, FBG and PPBG levels were analyzed using paired t-test with significance value of 5%. Trial Registration: CTRI No. CTRI/2017/02/007878. Results: A total of 1,542 participants were enrolled and 1,365 completed two study visits. Mean HbA1c was 8.27% at baseline, which reduced to 7.29% at week 12 (0.98% change, p<0.001). At week 12, mean reductions in FBG and PPBG levels and bodyweight were 27.1 mg/dL (p<0.001), 52.2 mg/dL (p<0.001), and 1.00 kg (p=0.121), respectively. Most participants (75%) received voglibose as add-on therapy and the most commonly prescribed concomitant oral antidiabetic drugs were metformin and sulfonylurea (29%). Flatulence (0.5%) and abdominal discomfort (0.3%) were the most commonly reported adverse events in the study. Conclusions: Voglibose, monotherapy or add-on therapy, significantly reduced HbA1c, FBG and PPBG and was well tolerated in patients with T2DM in a real-world setting.