1837-P: Efficacy and Safety of DAPA/MET Fixed-Dose Combination (FDC) vs. Co-Administration (Co-ADM) in Chinese Patients with T2DM

Introduction and Objective: DAPA+MET provides effective glycemic control and cardiorenal benefits in T2DM, and FDC simplifies therapy. This is the first study comparing DAPA/MET FDC with CO-ADM in Chinese pts with T2DM. Methods: EFFICIENT (NCT06327815) was a 24-week, multicenter, randomized, open-label, non-inferiority study. Pts aged 18-80 years with newly diagnosed T2DM were randomized to DAPA+MET FDC or CO-ADM. The primary endpoint was the change from baseline (Δ) in HbA1c at Week 24 (non-inferiority margin: 0.3%). Secondary endpoints included ΔFPG, ΔPPG, proportion of pts with HbA1c <7%, etc. Safety was also assessed. Results: The FAS included 590 pts (FDC: 297; CO-ADM: 293) with balanced baseline characteristics. LS mean ΔHbA1c at Week 24 was -2.06% with FDC vs -2.12% with CO-ADM (LS mean diff 0.06%, 95% CI [-0.05, 0.17]), meeting non-inferiority criterion. Both groups had reductions in FPG and PPG, with >70% achieving HbA1c <7%. CGM metrics far exceeded guideline targets. TRAEs occurred in 23.7% vs 25.4%, mostly mild. See Table for full results. Conclusion: This is the first study evaluating DAPA/MET FDC in pts with newly diagnosed T2DM worldwide, providing direct evidence for T2DM management. At Week 24, the FDC demonstrated effective glycemic control with a favorable safety profile, comparable to CO-ADM. These findings support SGLT2i/MET FDC as an effective, well-tolerated and simplified treatment option for T2DM. Disclosure J. Liu: None. Y. Wei: None. P. Shi: None. J. Chen: None. L. Xu: None. Y. Kong: None. J. Ye: None. X. Wang: None. J. Xu: None. L. Wang: None. L. Li: Employee; Current; AstraZeneca. G. Wang: None. Funding AstraZeneca China