Dapagliflozin Versus Vildagliptin as an Adjuvant to Metformin in Patients With Type 2 Diabetes Mellitus: A Randomized, Open-label Study.

Introduction: The rising burden of diabetes mellitus led to the development of novel drugs like dapagliflozin and vildagliptin. Their efficacies in chronic diabetic patients have been thoroughly studied. However, there is a paucity of comparative studies on these drugs in newly diagnosed diabetic patients. The endpoints of our study were changes in glycated hemoglobin (HbA _1c ), fasting blood glucose (FBG), and postprandial blood glucose (PPBG) at 24 weeks from baseline.
Methods: This randomized, open-label, 24-week study was conducted at Kalinga Institute of Medical Sciences, Bhubaneswar, India, from January 2021 to November 2022. The participants were randomized in a 1:1 ratio to receive tablets of either dapagliflozin 10mg once daily or vildagliptin 50mg once daily as an add-on to metformin 500-2000 mg. The analyses were performed in the per-protocol population. We used R software v. 4.1.1 (R Foundation, Indianapolis, IN) for data analysis.
Results: 114 (83.8%) of 136 enrolled participants completed this study. The mean age of the study population was 41.08±5.17 years. Additionally, 52 (45.6%) of them were females. The mean changes in HbA _1c from baseline were -1.19 (95% CI: -1.36 to -1.03) and -1.28 (95% CI: -1.37 to -1.18) in dapagliflozin and vildagliptin groups, respectively (p=0.21). The median changes in FBG and PPBG in both groups were -38.76, -46.13 (p=0.07), and -51.84, -53.56 (p=0.14), respectively.
Conclusions: Reductions in HbA _1c , FBG, and PPBG with add-on treatment of vildagliptin were more pronounced than dapagliflozin after a 24-week intervention. However, the differences were not statistically significant.
Competing Interests: The authors have declared that no competing interests exist.
(Copyright © 2023, Gautam et al.)