Abstract
Dipeptidyl peptidase-4 inhibitors (DPP4Is) were introduced for the management of type 2 diabetes mellitus (T2DM) due to their insulinotropic effects, lack of inherent hypoglycemia risk, and neutral impact on body weight. Vildagliptin is a dipeptidyl peptidase-4 inhibitor that improves glycemic control by increasing the incretin levels and prolonging the effect of glucagon-like peptide 1 (GLP- 1). Due to its unique mechanism of action for glycemic control and its advantages, DPP-4 inhibitors have been widely used alone in monotherapy or combined with metformin. The present study aimed to evaluate the efficacy and safety of Vildagliptin 100 mg sustained release tablet once daily (SR tablet OD) compared to Sitagliptin 100 mg tablet in patients with Type 2 diabetes mellitus not optimally controlled on Metformin alone. A total of three sites were involved in the enrollment of 128 Type 2 diabetes mellitus patients, with 64 patients in each treatment arm. 50 patients were selected to monitor the average blood glucose levels by continuous glucose monitoring system (CGMS) measurements in a subset of population with 25 patients in each treatment arm. Eligible patients were randomly assigned to receive (orally) Vildagliptin sustained release tablets 100 mg or Sitagliptin tablets IP 100 mg with metformin once daily for 84 days. The reduction in HbA1c, fasting blood glucose (FBG) levels, postprandial blood glucose (PPBG) levels and the average glucose values measured using the Continuous Glucose Monitoring system (CGMS) from baseline to the end of treatment (Day 84±3) were found to be -0.22%, -1.43 mg/dL, 2.55 mg/dL, and -19.14 mg/dL respectively indicating that Vildagliptin 100 mg Sustained Release Tablet administered once daily in patients with Type 2 diabetes mellitus who are not optimally controlled on metformin alone is beneficial for better patient compliance towards effective glycemic control while reducing the frequency of dosing.