ABSTRACT:
Background: Type 2 diabetes mellitus (T2DM) often requires second-line therapy despite metformin use. SGLT2 inhibitors like Empagliflozin and Dapagliflozin improve blood glucose regulation, weight, and cardiovascular health but differ in efficacy and reliability. Limited comparative data exist, making their evaluation essential for optimizing treatment in Patients with inadequate blood glucose regulation. Objective: Present study designed to assess and compare effectiveness and reliability associated with Empagliflozin versus Dapagliflozin when used alongside metformin in Patients with inadequately Controlled T2DM, providing insights into their relative benefits and risks in the study population. Materials and Methods: A Randomized, Prospective, Open-label, Observational investigation was sought to evaluate the effects of Tablet. Metformin 500mg (BID) with Tablet. Empagliflozin 25mg (OD) in contrast to Tablet. Metformin 500mg (BID) with Tab. Dapagliflozin 10mg (OD) in South Indian Patients with inadequate control of T2DM. This research work was carried out at the Outpatient unit of endocrinology and metabolic clinic of SBMCH, Chennai, India from October 2023 to September 2024. The total study period was 24 weeks. Results: On the estimation of serum FBS levels at 4 and 12 weeks, it was found that the FBS values from both classes had significantly decreased when compared with the baseline. In the 24th week, the mean FBS value in the Empagliflozin class was 124.9±9.8, and in the Dapagliflozin class was 123.2±9.9. In the 24th week, the mean PPBS values in Patients taking Tab Metformin with Tab Empagliflozin was 170.6±16.6, and in Patients taking Tab Metformin with Tab Dapagliflozin was 178.1±23.6. Therefore, a better reduction was observed in the Empagliflozin class than in the Dapagliflozin class. No statistical significance was noted . In the 24th week, the mean HbA1c values in Patients taking Tab Metformin with Tab Empagliflozin was 7.2±0.4, and in Patients taking Tab Metformin with Tab Dapagliflozin was 7.4±0.5 and was found to be statistically significant. There was an overall diminution in mean HbA1c values from pre-intervention to post intervention study period in both arms, but a validated specified confidence threshold reduction was seen in Empagliflozin class than Dapagliflozin class, though there is no significant difference in before and after meal decline in sugar levels in terms of clinical outcome (strongly associated p<0.01). Conclusion: Future long-term real-world studies are needed to validate the findings across a broader patient population.