A Randomized, Double-blind, Active-controlled Study of Remogliflozin Etabonate 100 mg plus Teneligliptin 10 mg Twice-daily versus Teneligliptin 20 mg Oncedaily as add-on to Metformin Monotherapy in Indian Diabetic Patients

Abstract

Background: Fixed-dose combination (FDC) of sodium-glucose co-transporter-2 inhibitor (SGLT2i) and dipeptidyl peptidase-4 inhibitor (DPP4i) is a promising approach for type 2 diabetes (T2D) management due to their complementary mode of action. The present study evaluated efficacy and safety of FDC of remogliflozin etabonate (RE) and teneligliptin as add-on to metformin monotherapy in uncontrolled T2D patients compared to standard teneligliptin therapy. Methods: This 16-week, double-blind, double-dummy, active-controlled, parallel-group, multicentric study randomized 308 patients (glycated hemoglobin levels [HbA1c] 8-11%) who were on background metformin therapy (≥1500 mg/day) to receive add-on treatment of either RE 100 mg plus teneligliptin 10 mg twice-daily (RE+TE10) or teneligliptin 20 mg (TE20) once-daily. The primary endpoint was mean change in HbA1c from baseline to Week 16. Secondary endpoints were changes in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and body weight from baseline to Week 16. Safety endpoints were assessed throughout the study. Results: At Week 16, significant reduction in HbA1c, FPG, PPG and body weight were noted in both the groups. The mean change in HbA1c from baseline to Week 16 was superior in the RE+TE10 (-1.23%) versus TE20 (-0.79%), whereas the mean change in FPG, PPG, body weight along with incidence of treatment-emergent adverse events (RE+T10: 11.8% vs. T20: 14.2%) were comparable between the two groups. Conclusion: FDC of remogliflozin/teneligliptin was superior to teneligliptin as an add-on to metformin in HbA1c reduction from baseline to Week 16 in Indian patients with uncontrolled T2DM on metformin therapy and was well-tolerated.