iSGLT2 Inhibitor and a iDPP -4 Inhibitor in Treatment of Type 2 Diabetes Mellitus in Patients Treated With Metformin (TRIAD)

This is a phase III, multicenter, randomized, double-blind, double-dummy clinical trial to evaluate the efficacy and safety of the he fixed-dose combination in patients diagnosed with type 2 DM (Diabetes mellitus), with or without cardiovascular or renal complications, and who did not reach the therapeutic goals of glycemic control with previous guidance on diet and physical exercise, on monotherapy with metformin at the maximum tolerated dose, and who, at the discretion of the Investigator, may benefit from the addition of trial drugs. The trial will have a total duration of a maximum of 144 days (approximately 20 weeks), with a screening/run-in period of up to 4 weeks and 16 weeks (112 ± 4 days) of treatment. The trial will include a screening visit (V-1), a baseline randomisation visit (V0), three follow-up visits (V1, V2, V3) and a final visit (V4).