A RANDOMIZED, OPEN LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF VILDAGLIPTIN AND METFORMIN COMBINATION VERSUS VILDAGLIPTIN ALONE IN TYPE 2 DIABETES MELLITUS PATIENTS IN A TERTIARY CARE HOSPITAL.

Introduction: During recent years there has been a discussion of introducing initial combination therapy when pharmacological treatment is required for type 2 diabetes, in order to reach therapeutic goal at an earlier stage and to avoid or delay subsequent changes in therapy for the maintenance of therapeutic goal. The present study is undertaken to compare the efficacy of combination of Vildagliptin and Metformin with that of Metformin alone in patients with type II Diabetes Mellitus for reducing glycemic parameters (HbA1C, fasting blood glucose and post prandial blood glucose). Material and methods: Patients attending the Out Patient Departments of General Medicine and Diabetology of a tertiary care hospital. This was an open label, prospective, randomized, observational study. Results: In this study 2 major findings were observed: 1. Vildagliptin combination with Metformin and metformin monotherpy provided statistically significant additional decrease in HbA1C, Fasting Blood Sugar and Post-Prandial Blood Sugar levels as compared from baseline. There was also a statistically significant decrease with respect to HbA1C level, Fasting Blood Sugar and Post-Prandial Blood Sugar levels in the combination group as compared to the monotherapy group