A randomized, double-blind, active-controlled trial assessing the efficacy and safety of a fixed-dose combination (FDC) of MEtformin hydrochloride 1000 mg ER, SItagliptin phosphate 100 mg, and DApagliflozin propanediol 10 mg in Indian adults with type 2 diabetes: The MESIDA trial

Objective To assess the efficacy and safety of fixed-dose combinations (FDC) of triple-drug dapagliflozin, sitagliptin, and metformin (DSM) compared with FDC of two-drug sitagliptin and metformin (SM), in Indian adult patients with type 2 diabetes (T2D). Methods A multicentric, randomized, double-blind, active-controlled, Phase 3 study (CTRI/2021/10/037461) was conducted on 274 Indian adult patients with T2D. Patients were randomized (1:1) to receive either an FDC of triple-drug ( n = 137) dapagliflozin propanediol 10 mg, sitagliptin phosphate 100 mg, and metformin hydrochloride 1000 mg extended-release (DSM) or FDC of two-drug ( n = 137) sitagliptin phosphate 100 mg and metformin hydrochloride 1000 mg sustained-release (SM), for 16 weeks. The primary endpoint was a change in HbA1c, while the secondary endpoints were changes in fasting plasma glucose (FPG), postprandial glucose (PPG), body weight, and safety. Results Both DSM and SM FDCs reduced HbA1c significantly (-1.45% and -1.00%, respectively, both p