Indian Study Finds Vildagliptin SR Effective and Safe in Type 2 Diabetes Patients Uncontrolled on Metformin: PRIME-Vilda Trial
Vildagliptin SR 100 mg once daily has been shown to be effective and safe in improving glycemic control in Indian T2DM patients in India not adequately managed with metformin alone, while offering the advantage of reduced dosing frequency, as demonstrated in the recent PRIME-Vilda trial. The study was published in the May 2025 issue ofMedical Research Archives- the Journal of the European Society of Medicine. Vildagliptin, a DPP-4 inhibitor, enhances glycemic control by boosting incretin levels and extending the action of glucagon-like peptide 1 (GLP1). Its low risk of hypoglycemia and weight neutrality make DPP-4 inhibitors suitable for monotherapy or use with metformin. The sustained-release (SR) formulation of vildagliptin 100 mg ensures steady drug levels through the gradual release of the active pharmaceutical ingredient (API). A prospective, multi-centre, parallel-group study was conducted to assess the efficacy and safety of Vildagliptin 100 mg SR Tablet OD compared to Sitagliptin 100 mg tablet in patients with type 2 diabetes mellitus inadequately controlled on metformin alone. The study enrolled 128 patients with Type 2 diabetes mellitus across three sites, who were randomly assigned to receive (orally) either Vildagliptin SR 100 mg (n=64) or Sitagliptin 100 mg (n=64), along with metformin, once daily for 84±3 days. A subset of 50 patients, 25 from each group, underwent Continuous Glucose Monitoring System (CGMS) assessment to evaluate average blood glucose levels. Efficacy analyses included changes in HbA1c, fasting blood glucose (FBG), and postprandial blood glucose (PPBG) levels, while safety evaluations included kidney and liver function, electrocardiograms (ECG), and monitoring of adverse events. The results revealed findings which include: Glucose Lowering Efficacy: Figure 1: Mean Change in HbA1c (%), Fasting Blood Glucose (FBG) (mg/dL) and Postprandial Blood Glucose (PPBG) (mg/dL) with Vildagliptin(T) vs Sitagliptin(R) from Baseline to Visit 5 Renal & Hepatic Function Parameters: Lipid & Heart Assessment: Vildagliptin 100 mg SR once daily demonstrated effective glycemic control, good tolerability, and a favorable safety profile in patients with Type 2 diabetes inadequately controlled on metformin alone in Indian clinical settings. All patients successfully completed the treatment course without interruption, thus highlighting the sustained glycemic efficacy of the therapy.
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