Efficacy and Safety of a Combination of Remogliflozin Etabonate and Vildagliptin as Fixed Doses in Patients with Type-2 Diabetes Mellitus: A Randomized, Active-Controlled, Double-Blind Study. (FOREVER STUDY)

Abstract Aims: The study aimed at evaluating efficacy and safety of Remogliflozin etabonate and Vildagliptin fixed dose combination (FDC) compared to currently approved FDC of Empagliflozin and Linagliptin. Methods: A randomized, double-dummy, double-blind, active-controlled, parallel-group, two-arm, multi-center study was conducted at 26 sites across India. Type-2 diabetes mellitus (T2DM) patients aged between 18-65 years on metformin ≥1500 mg were randomized to receive either Remogliflozin Etabonate and Vildagliptin (RV) or Empagliflozin and Linagliptin (EL) with matched placebo. Results: A total of 400 study participants with T2DM who had inadequate glycemic control with stable metformin dose as monotherapy were enrolled. At end of study duration i.e. week 16, there was a statistically significant change from baseline in HbA1c levels in both the groups i.e. -1.38% in the RV group and -1.46% in the EL group (p <0.001). The difference between the RV group and EL group was -0.08% (90% CI difference: -0.28, 0.13). Similarly, statistically significant changes from baseline to week 16 in fasting plasma glucose (FPG) and post prandial glucose (PPG) levels were seen in RV group and EL group (p <0.001) with no statistically significant differences seen between the groups. The safety profile of both the FDC’s were comparable. Conclusion: The FDC of Remogliflozin and Vildagliptin was found to be non-inferior to FDC of Empagliflozin and Linagliptin in terms of efficacy and safety. This FDC of Remogliflozin and Vildagliptin provides an alternative to the management of Indian T2DM patients requiring SGLT2 inhibitor and DPP4 inhibitor combination.