The Real DAPSI: A Real-World Retrospective Study on Assessing the Efficacy and Safety of a Fixed-Dose Combination of Dapagliflozin and Sitagliptin in the Indian Population

Introduction Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder affecting millions of individuals worldwide. Effective management of T2DM is crucial to prevent complications. Dapagliflozin and sitagliptin are oral anti-diabetic agents that have been shown to provide synergistic effects in controlling blood glucose levels. However, there is limited data on the efficacy and safety of the dapagliflozin-sitagliptin fixed-dose combination (FDC) in the Indian population. This study aimed to evaluate the real-world effectiveness and safety of the dapagliflozin-sitagliptin FDC in the Indian population. Methods This was a retrospective study conducted at healthcare centers in India. The study included patients with T2DM who were prescribed a FDC of dapagliflozin and sitagliptin. Data were collected from the medical health records of patients, including demographics, baseline glycated hemoglobin (HbA1c), blood glucose levels, BMI, blood pressure, and adverse events. The primary outcome was the change in HbA1c, postprandial plasma glucose (PPG), and fasting plasma glucose (FPG) from baseline to 12 weeks after treatment initiation. Results A total of 358 patients were included in the study, with a mean age of 56.2 years. The majority of the patients were male (68.2%), and the mean baseline HbA1c was 8.9 ± 0.87%. After 12 weeks of treatment with dapagliflozin and sitagliptin, there was a significant reduction in HbA1c levels from 8.9 to 7.2 (p <0.0001). There was also a significant reduction in fasting blood glucose levels from 178.8 to 124.0 (p <0.0001) and postprandial blood glucose levels from 273.9 to 176.0 (p <0.0001). There were no serious adverse events reported during the study period. Conclusion The FDC of dapagliflozin and sitagliptin is effective and safe in reducing blood glucose levels and BMI in the Indian population with T2DM. This real-world retrospective study provides valuable insights into the clinical effectiveness and safety of dapagliflozin-sitagliptin FDC in the Indian population. These findings highlight the potential benefits of this combination therapy in managing T2DM and pave the way for optimized treatment strategies and improved patient outcomes in the Indian healthcare landscape. Clinicians may consider dapagliflozin-sitagliptin FDC as a viable treatment option for T2DM patients.