FRI649 ADMIRE: Assessing Dapagliflozin And Metformin As An Initial Regimen In Diabetes Mellitus For Enhanced Glucose Control

Disclosure: D. Phadke: None. D. Gopal: None. D. Biswas: None. D. Birla: None. A. Prasad: None. P. Joshi: None. Introduction: Early aggressive glucose lowering in type 2 diabetes mellitus (T2DM) has shown improved outcomes, and combination oral antidiabetic agents (OAAs) on top of lifestyle therapy are necessary. In India, most T2DM patients receive combination therapy with two or more OAAs to achieve glycemic targets more rapidly. The fixed dose combination (FDC) of dapagliflozin and metformin is widely used in India, as it improves glycemia, reduces weight and blood pressure (BP), and has good tolerability. This study aimed to evaluate physician practices, efficacy, and tolerability of dapagliflozin and metformin FDC as initial therapy for T2DM patients in a real-world setting. Methods: This multicenter, retrospective, observational study enrolled 481 T2DM patients across 49 clinical units for a period of 6 months. The study aimed to evaluate physician practices, efficacy, and tolerability of dapagliflozin and metformin FDC as the initial choice FDC in T2DM. The study was conducted in compliance with the principles of the Declaration of Helsinki, good clinical practice, and regulatory guidelines. Ethical approval for the study was obtained on August 6, 2022, and the study was conducted from August 15, 2022, to January 20, 2023. Results: The study demonstrated that dapagliflozin and metformin FDC significantly reduced weight by 4.2 kg (p < 0.0001), fasting plasma glucose by 21.4 mg/dL (p < 0.0001), and improved estimated glomerular filtration rate (eGFR) by 1.9 m²/1.73 ml/min (p < 0.0001). Additionally, systolic BP was reduced by 10.7 mmHg (p < 0.0001), and diastolic BP was reduced by 6.6 mmHg (p < 0.0001), which is in combination with the concomitant medications. Incidence of genito-urinary tract infection was 8.9%. Conclusion: In a real-world setting, dapagliflozin and metformin FDC can be used as initial therapy for T2DM with good efficacy, tolerability, and safety. Physicians preferred this combination due to its ability to promote weight loss, reduce cardiovascular events, and decline in renal function. The excellent safety and efficacy reported by physicians for this FDC of dapagliflozin and metformin has contributed to improved compliance with the treatment. Thus, in the Indian population, dapagliflozin and metformin FDC is effective, safe, and has good tolerability as an initial therapy for T2DM. Presentation: Friday, June 16, 2023