Patient Profiling and Outcome Assessment of Vildagliptin and Dapagliflozin FDC in Persons with Type 2 Diabetes Mellitus

Abstract

Introduction: Type 2 Diabetes Mellitus (T2D) is a condition characterized by rapid progression, and in certain instances, managing glucose levels may not be adequately achieved with a single pill. Vildagliptin and dapagliflozin in a Fixed-Dose Combination (FDC) complement each other's actions, aiding in the control of glycemia. The primary goal of this retrospective investigation was to gain insight into the patient characteristics, safety profile, and efficacy of the FDC in reducing weight and glycated hemoglobin levels.

Methods: Retrospective data from T2D patients who were prescribed the FDC and had two follow-up visits between May 1, 2022, and January 31, 2023, were enrolled in the study.

Results: The average age of the study sample was 55.8 years, with nearly two-thirds being male (65.5%). At 6 months after FDC medication, glycated hemoglobin (HbA1c) significantly decreased by 1.2% (Baseline: 8.4%, Follow-up: 7.2%, p-value <0.001), indicating improved glycemic control. An average weight decrease of 4.3 kg (Baseline: 76.9Kg, Follow-up: 72.5Kg. p-value <0.001), was noted in patients receiving the FDC. Weight loss was higher in males (4.5 kg) than in females (4.0 kg). Safety analysis was carried out for all randomized patients and no major AEs were noted. No patients were withdrawn from the study due to safety concerns. No episode of hypoglycemia occurred during the study time. There were no statistical differences in the hepatic enzymes at the end of six months in the study groups.

Conclusion: The Fixed Dose Combination of Vildagliptin and Dapagliflozin effectively enhances glycemic control by demonstrating a significant reduction in mean HbA1c levels after six months compared to baseline. However, further multicenter studies are necessary to substantiate these findings.