Efficacy and Safety of Vildagliptin and Remogliflozin as Add-On Therapy to Metformin in Patients of Type 2 Diabetes Mellitus: An open-label comparative study

Objectives: Metformin is considered as first-line drug in Type 2 Diabetes Mellitus (T2DM). However, as disease progresses with heightened insulin resistance and declining β-cell function, use of metformin alone is often inadequate to achieve optimum glucose level. The aim of this study was to evaluate safety and efficacy of remogliflozin in comparison to vildagliptin as add-on drug to metformin in T2DM. Methods: This prospective, randomized study was conducted at ESIC Hospital, Faridabad, India between February 2020 to January 2021, recruited patients with T2DM with HbA1c >6.5 % taking metformin at daily dosage of ≥1500 to ≤3000 mg for ≥3 months with age between 35-70 years. Patients were randomly assigned into 1:1 ratio to receive either vildagliptin (50mg) or remogliflozin (100mg) twice daily for 90 days. The primary endpoint was change in HbA1c levels from baseline to end of 90 days whereas secondary endpoints were changes in lipid profile and weight. Results: 60 patients underwent randomization of which, 30 each were assigned to receive either vildagliptin or remogliflozin. On analysis it was found that decrement in mean HbA1c levels was significantly higher in remogliflozin group than in vildagliptin group (-8.1% vs. -2.4%, P<0.001). Also, there was more significant weight loss in remogliflozin treated patients (-5.2% vs. -0.6%, P<0.01). Both treatments were well tolerated over the course of study. Conclusions: Compared to vildagliptin, remoglilflozin was significantly more effective in glycemic control and weight loss in T2DM and therefore can be considered as add-on drug in T2DM not adequately controlled by metformin monotherapy. Keywords: Remogliflozin; Vildagliptin; Metformin; Type 2 Diabetes Mellitus; Efficacy; Safety; Glycaemic Control; Weight Loss