Effectiveness and Safety of a Fixed-Dose Combination of Dapagliflozin and Vildagliptin in the Treatment of Type 2 Diabetes Mellitus: A Retrospective Study.

Introduction The fixed-dose combination (FDC) of dapagliflozin 5 mg and vildagliptin 50 mg has been recently approved, but real-world data on its effectiveness and safety are limited. We aimed to evaluate the glycemic efficacy and safety of a combination therapy of dapagliflozin 5 mg and vildagliptin 50 mg in patients with type 2 diabetes mellitus (T2DM) over a three-month period. Materials and methods This single-center study retrospectively analyzed data from 49 T2DM patients treated with the FDC of dapagliflozin 5 mg and vildagliptin 50 mg, and complete baseline and three-month follow-up records were analyzed. The primary endpoint was the mean change in glycated hemoglobin (HbA1c). Secondary endpoints included fasting plasma glucose (FPG), postprandial plasma glucose (PPG), lipid profiles, and liver enzymes. Safety assessments included the frequency and nature of adverse events (AEs), such as hypoglycemia, genitourinary infections, gastrointestinal symptoms, and abnormalities in hepatic or renal function. Tolerability was defined as the absence of therapy discontinuation due to adverse effects. Results The study enrolled 101 patients with T2DM, of whom 49 patients completed the three-month follow-up (mean age: 55.31 ± 12.04 years) and were included in the analysis. The majority were obese based on Asia-Pacific/Indian body mass index (BMI) criteria (mean BMI: 27.25 ± 4.38 kg/m²). At baseline, the mean HbA1c was 8.87 ± 1.65%, with most patients having HbA1c levels above 8%. After three months of treatment, significant improvements in glycemic parameters were observed, with HbA1c reduced by 1.65 ± 1.23% (p < 0.001), FPG by 68.14 ± 54.31 mg/dL (p < 0.001), and PPG by 122.45 ± 83.08 mg/dL (p < 0.001). Lipid and liver enzyme profiles also showed significant improvement. Subgroup analyses showed consistent glycemic benefits across age, BMI, diabetes duration, and comorbidity categories. The FDC was well tolerated, with no serious AEs and only mild, self-limiting side effects. Conclusions This retrospective, single-center, short-term study suggests that dapagliflozin 5 mg and vildagliptin 50 mg may improve glycemic control in patients with T2DM over a three-month period; however, larger, long-term studies are required to confirm durability and safety.