1839-P: Real-World Effectiveness and Safety of Dapagliflozin/Glimepiride/Metformin Fixed-Dose Combinations (FDC) in Indian Adults with Type 2 Diabetes Mellitus (T2DM): Insights from BENEFACTOR Study

Introduction and Objective: Indian T2D patients often present with high HbA1c (>8.5%) & remain uncontrolled despite treatment, indicating need for early combination therapy as per ADA 2026 guidelines. FDC of Dapagliflozin, Glimepiride, Metformin (DGM) leverages complementary mechanisms to enhance glycemic control & adherence. This study evaluated effectiveness & safety of DGM FDC in T2DM patients. Methods: Retrospective, multicenter study included T2D adults prescribed DGM FDC. Major outcomes - changes in HbA1c, FBG, PPBG & tolerability at 12±2 wks. Predefined subgroups analyses of age (<45 & ≥45y), T2D duration (<1, 1-3, >3y), baseline HbA1c (<9 & ≥9%), BMI ≥25 kg/m² also performed. Multivariable regression identified independent predictors of HbA1c reduction. Results: Among 3770 patients (mean age 56.3±10.7 yrs; 74.7% male), significant mean (±SEM) reductions observed in HbA1c (−1.46±0.02%), FBG (−46.99±0.81 mg/dL), PPBG (−71.11±1.24 mg/dL) at 12±2 weeks (all p<0.0001). HbA1c <7% achieved by 35.97% (n=1,356). Glycemic improvements were consistent across all predefined subgroups (all p<0.0001). Patients with >3 yrs T2D duration showed greater absolute reductions (-0.3%), indicating preserved efficacy in longer-standing, metabolically complex disease. Greater reductions noted in patients aged <45 yrs (-0.13%) & those with baseline HbA1c ≥9% (-0.59%), supporting early intensification & indicating amplified response in severely uncontrolled T2D. Regression analysis identified younger age & higher baseline HbA1c as significant predictors of HbA1c reduction (p<0.05), highlighting phenotype-driven glycemic response. AEs were infrequent (7.9%), mostly mild. Hypoglycemia occurred in 4.56%; mostly in newly diagnosed & ≥45y patients. Conclusion: DGM FDC produced rapid, clinically meaningful glycemic improvements across diverse phenotypes, aligning with ADA 2026 recommendations emphasizing early intensification & phenotype-guided therapy. Disclosure L. Murthy: None. S. Bhattacharyya: None. A. Kakkad: Employee; Current; Torrent Pharmaceuticals Limited. M. Gabhane: Employee; Current; Torrent Pharmaceuticals Limited. L. Kumar: Employee; Current; Torrent Pharmaceuticals Limited. G. Kulkarni: Employee; Current; Torrent Pharmaceuticals Limited.