932-P: Clinical Efficacy, Safety, and Tolerability of Single-Pill Combination of Dapagliflozin and Linagliptin in Uncontrolled Indian Type 2 Diabetes Mellitus Patients—A Randomized Double-Blind Study

Introduction: While Dapagliflozin and Linagliptin are known for robust glycaemic efficacy T2DM patients when used individually, although it remained unknown whether their combined use is associated with further improved efficacy, safety and tolerability in Indian scenario. Objective: To determine whether Dapagliflozin 10mg-Linagliptin 5mg (group 1) is associated with an improved glycemia compared with Linagliptin (group 2) alone in uncontrolled on metformin monotherapy. Method: In a Phase 3, randomized, double blind, active-controlled, double dummy study, a total of 232 T2DM patients on stable dose of metformin were randomized to a group 1 and 2 for 16 weeks. The endpoints included were mean change in glycemic and metabolic parameters. Statistical analysis was conducted using SAS 9.4. Results: At baseline, mean (SD) for age, weight, BMI was 46.5 (10.52) years, 62.17 (7.57) kg and 23.76 (2.61) kg/m2. At end of 16 weeks, mean reductions in HbA1c (±SE) in group 1 was -1.36 ±0.05 % with difference in mean (SE) -0.44 (95% CI -0.59 to -0.29) %, in FPG -25.90 (1.23) %, 2-hr PPG -52.41 (2.29)% was reported from baseline. About 49% subjects achieved therapeutic glycaemic response in group 1 compared to 26% of group 2 and modest weight reduction from baseline was observed (LSM (SE) -1.34 (0.07) kg in group 1 with mean difference of -0.93 (0.1) kg. AEs reported were twelve in group 1 and ten in group 2, which were mild-moderate in nature. Conclusion: Dapagliflozin-Linagliptin combination provided superior glycemic control with good tolerability and safety profile in Indian T2DM patients uncontrolled on metformin monotherapy. Disclosure J. Ahmad: None. S. Ghosh: None. P.P. Kumthekar: None. M.R. Upadhyay: None. K.S. Sonawane: None. M. Khalse: Employee; Lupin Limited. K. Patel: None.