Evaluation of Vildagliptin SR vs Sitagliptin in Type 2 Diabetes Management

Study Overview

The study assesses the efficacy and safety of once-daily Vildagliptin SR 100 mg compared to Sitagliptin 100 mg in patients with type 2 diabetes who are inadequately controlled on Metformin. This research, known as the PRIME-Vilda trial, was led by a team of prominent endocrinologists: Dr. Abdul Hamid Zargar, Dr. Sunil Gupta, Dr. Balaji Jaganmohan, Dr. Faraz Farista, Dr. Chetan Patil, and Dr. Sachin Yadav. The findings were published in the May 2025 issue of the Medical Research Archives by the European Society of Medicine.

Study Design

This prospective, multicenter, parallel-group study involved three healthcare centers in India and enrolled 128 patients aged between 28 and 75 years, all with HbA1c levels exceeding 7%. Participants were randomly assigned into two groups: one group received Vildagliptin sustained-release 100 mg tablets, while the other group received Sitagliptin 100 mg tablets. Both medications were taken once daily in conjunction with Metformin (at least 1,000 mg per day) for a treatment duration of 84 days, or approximately 12 weeks.

Efficacy Endpoints

The primary efficacy endpoint focused on the change in HbA1c levels from baseline to the conclusion of treatment. Secondary efficacy endpoints included changes in Fasting Blood Glucose (FBG) levels, Postprandial Blood Glucose (PPBG) levels, and average blood glucose levels monitored via Continuous Glucose Monitoring System (CGMS).

Key Findings

The study yielded several important findings:

– **HbA1c Reduction**: The Vildagliptin 100 mg SR tablet resulted in a mean reduction of -1.35% in HbA1c from baseline, while the Sitagliptin 100 mg tablet achieved a -1.13% decrease. The difference in HbA1c change between the two treatments was -0.22%.

– **Blood Glucose Levels**: Vildagliptin demonstrated superior glycemic improvement, reducing Fasting Plasma Glucose (FPG) by 39.38 mg/dL compared to 28.87 mg/dL with Sitagliptin. Additionally, Vildagliptin led to a reduction in Postprandial Glucose (PPG) levels by 53.02 mg/dL, while Sitagliptin reduced PPG by 52.65 mg/dL.

– **Continuous Glucose Monitoring System (CGMS)**: Average glucose values measured by CGMS decreased by -30.50 mg/dL in the Vildagliptin SR group, in contrast to -11.36 mg/dL in the Sitagliptin group.

Achievement of Glycemic Targets

The study indicated that 58% of patients on Vildagliptin were able to achieve their HbA1c targets, highlighting the effectiveness of Vildagliptin in managing diabetes in this patient population.