1844-P: Metabolic, Hepatic, Renal, and Hemodynamic Effects of DA-2811 vs. Forxiga in Patients with Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Noninferiority Study

Introduction and Objective: This study evaluated whether DA-2811 (DAPAPRO®, dapagliflozin formate) demonstrates effects comparable to FORXIGA® (dapagliflozin propanediol hydrate) on glycemic control as well as metabolic, hepatic, renal, and cardiovascular parameters in patients with type 2 diabetes mellitus (T2DM), which are recognized benefits of SGLT-2 inhibitors. Methods: This multicenter, randomized, double-blind, active-controlled, parallel study enrolled T2DM patients receiving stable metformin monotherapy with HbA1c 7.0-10.0% at screening. Participants were randomized 1:1 to DA-2811 or FORXIGA®. The primary endpoint was HbA1c change from baseline to Week 24. Secondary endpoints were LS mean changes in lipids, hepatic enzymes, renal markers, blood pressure, body weight and waist circumference, analyzed using an MMRM model. Results: A total of 225 participants (DA-2811, n=112; FORXIGA®, n=113) were included in the efficacy analyses, with balanced baseline characteristics. DA-2811 demonstrated non-inferiority to FORXIGA® for HbA1c change at week 24. At week 24, HDL-C increased (DA-2811: 3.57±0.75 mg/dL vs. FORXIGA®: 4.15±0.77 mg/dL), and triglycerides decreased (−10.42±4.59 vs. −16.62±4.70 mg/dL) in both groups, with no significant differences. Hepatic enzymes decreased similarly in both groups. Uric acid levels decreased, whereas eGFR, UACR, and NAG showed no meaningful changes. Systolic and diastolic blood pressure decreased modestly in both groups. Body weight and waist circumference significantly decreased in both groups. No significant between-group differences were observed for any metabolic, hepatic, renal, or hemodynamic outcome. Conclusion: DA-2811 and FORXIGA® demonstrated comparable effects over 24-weeks across metabolic, hepatic, renal, and hemodynamic parameters in adults with T2DM, supporting similar clinical profiles for both formulations in routine practice.