PRIME-Vilda Trial Results Highlights Vildagliptin SR's Efficacy and Safety in Indian Type 2 Diabetes Patients on Metformin - Video

The study evaluates the efficacy and safety of once-daily Vildagliptin SR 100 mg vs Sitagliptin 100 mg in type 2 diabetes patients inadequately controlled on Metformin.

PRIME-Vilda trial conducted by leading Endocrinologists Dr Abdul Hamid Zargar, Dr Sunil Gupta, Dr Balaji Jaganmohan, Dr Faraz Farista, Dr Chetan Patil and Dr Sachin Yadav published in the May 2025 issue of European Society of Medicine's Medical Research Archives.

A prospective, multicentre, parallel-group study was conducted across three healthcare centres in India, enrolling 128 patients aged 28–75 years with HbA1c levels above 7%.

128 participants were randomized into two groups: 64 received Vildagliptin sustained-release 100 mg tablets, and the other 64 received Sitagliptin 100 mg tablets, both administered once daily alongside metformin (≥1,000 mg per day) for a duration of 84 days (approximately 12 weeks).

Primary efficacy endpoint was the change in HbA1c levels from baseline to the end of treatment.

Secondary efficacy endpoints included changes in Fasting Blood Glucose (FBG) levels, Postprandial Blood Glucose (PPBG) levels, and average blood glucose levels measured by Continuous Glucose Monitoring System (CGMS).

Some of the key findings of the study are:

• HbA1c Reduction: Vildagliptin 100mg SR tablet led to a mean change of -1.35% in HbA1c from baseline, while Sitagliptin 100mg tablet resulted in a -1.13% decrease. The difference between the two treatments for HbA1c change was -0.22%
• Blood Glucose Levels:
• Fasting plasma glucose and Postprandial glucose levels: Vildagliptin showed greater glycemic improvement, reducing FPG by 39.38 mg/dL vs 28.87 mg/dL with Sitagliptin and PPG by 53.02 mg/dL vs 52.65 mg/dL with Sitagliptin.
• Continuous Glucose Monitoring System (CGMS): Average glucose values measured by CGMS decreased by -30.50 mg/dL in the Vildagliptin SR group, compared to -11.36 mg/dL in the Sitagliptin group.

• Achievement of Glycemic Targets: 58% of Vildagliptin patients achieved HbA1c <7% vs 42% with Sitagliptin.

Metabolic and Cardiovascular Safety: Vildagliptin showed stable renal/liver function, improved eGFR, better triglyceride/HDL trends, and favorable ECG changes.

Overall, the Vildagliptin 100mg SR tablet OD showed effective glycemic control and well-tolerated, while reducing the frequency of dosing, the study concluded.

Adapted from:

1) Zargar, AH., Gupta, S., et al., 2025. 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, [online] 13(5). https://doi.org/10.18103/mra.v13i5.6599