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 of Medical 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:
- No statistically significant differences were observed between Vildagliptin SR 100 mg and Sitagliptin 100 mg groups in the reduction of HbA1c (95% CI lower limit: –0.52; p = 0.152), FBG (–8.06; p = 0.719), PPBG (–7.12; p = 0.525), or average glucose levels measured by CGMS (–58.40 mg/dL; p = 0.332).
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
Safety:
- No treatment-related or emergent adverse events were reported, and no significant changes were observed in physical examination, vitals, laboratory parameters and ECG. No hypoglycemia episodes requiring assistance occurred in either group (Vildagliptin or Sitagliptin).
Renal & Hepatic Function Parameters:
- Renal function remained stable in both groups (Vildagliptin vs Sitagliptin), with minor changes in serum creatinine (–0.02 mg/dL), uric acid (–0.18 vs +0.10 mg/dL), and urea levels (–2.27 vs –1.31 mg/dL).
- Estimated glomerular filtration rate (eGFR) showed a slight increase in Vildagliptin and a slight decrease in Sitagliptin (+5.85 vs –0.90 mL/min/1.73 m²), indicating preserved renal function.
- Within hepatic parameters, bilirubin levels (total, direct, and indirect) showed minimal changes, with only a slight decrease in direct bilirubin (mean difference: –0.01 g/dL). Liver enzymes (AST, ALT, ALP) remained within normal limits with a slight reduction in ALP (mean difference, Test: -5.31 U/L, Reference: -16.30 U/L)
Lipid & Heart Assessment:
- Total cholesterol remained stable with Vildagliptin (+0.28 mg/dL) and slightly declined with Sitagliptin (−3.81 mg/dL); both groups showed marked reductions in triglycerides (−23.33 mg/dl and −25.13 mg/dL, respectively).
- HDL increased modestly (Vildagliptin: +1.04; Sitagliptin: +0.48 mg/dL), LDL decreased slightly (−2.27 and −2.31 mg/dL), and VLDL levels showed minimal change in both groups (-1.16 mg/dL and -0.07 mg/dL).
- Baseline ECG abnormalities such as sinus bradycardia, left axis deviation (LAD), left ventricular hypertrophy (LVH), T-wave changes, ST-T changes, and left anterior fascicular block (LAFB) were noted but regarded non-significant. By the end of treatment, a considerable number of participants showed favourable improvements in ECG.
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.
- 1. Patient-centered Assessment of the Efficacy and Safety of Vildagliptin Sustained-release Tablet (100 mg) Relative to Sitagliptin (100 mg) in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on MEtformin (PRIME-Vilda Trial) Medical Research Archives 13-
