Real-World Evaluation of Early Initiation of Dapagliflozin and Sitagliptin Combination Therapy in the Management of Type 2 Diabetes Mellitus (REALIZE Study).

Background Fixed-dose combinations (FDCs) of antidiabetic agents offer improved compliance and metabolic control in real-world settings. Objectives The present study assessed the effectiveness and safety of early initiation of an FDC of dapagliflozin and sitagliptin in Indian patients with type 2 diabetes mellitus (T2DM) and associated cardiometabolic comorbidities. Methodology  This retrospective, observational study included patients aged 18-59 years with T2DM, baseline BMI ≥25 kg/m², HbA1c levels between 7.0% and 10.5%, and prescribed the FDC of dapagliflozin and sitagliptin across five Indian centers. Effectiveness outcomes included changes in glycemic profile, renal function, body weight, BMI, serum triglycerides (TGs), and blood pressure (BP). Results  A total of 250 patients were included, with a mean age of 46.9 years, predominantly male. The mean waist circumference of 94.6 cm indicated central adiposity. Dyslipidemia and hypertension were the most common comorbidities. A significant reduction in glycated hemoglobin (HbA1c) was observed (-1.1%, p<0.001). Improvements in fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) were statistically significant. Patients with dyslipidemia or hypertension also experienced significant reductions. The study further demonstrated significant improvements in renal parameters. Body weight and BP were significantly reduced with this FDC. No adverse events were reported. Conclusion  Early initiation of an FDC of dapagliflozin and sitagliptin led to significant improvements in glycemic, renal, and cardiovascular parameters in patients with T2DM. Its favorable effectiveness and safety profile, even among those with common comorbidities such as hypertension and dyslipidemia, underscore its potential as a comprehensive treatment option in routine clinical practice.