A prospective open labelled study of effect of vildagliptin with metformin in patients with type 2 diabetes mellitus

ABSTRACT

Background: The pathophysiology of Type 2 Diabetes Mellitus (T2DM) is characterized by deficient insulin activity arising from decreased insulin secretion secondary to beta cell failure, and/or compromised insulin action in peripheral target tissues (insulin resistance).Methods: The patients attending the medicine outpatient department of tertiary care teaching hospital were enrolled in the study. Patients, who fulfilled the selection criteria, were allocated in two treatment groups. Group A was treated with metformin (Sustained release preparation) 500mg once daily and group B was treated with vildagliptin 50mg once daily. Measurement of body weight, fasting blood glucose (FPG), postprandial blood glucose (PPG), glycated haemoglobin (HbA1c), serum urea, creatinine and urine albumin/creatinine ratio was performed at the initial visit and at the end of 12 weeks of treatment.Results: Out of 84 patients screened, 74 were enrolled for the study. Of the 74 patients, 39(52.7%) were male and 35(47.3%) were female. The patients were divided into two groups (group A and group B) consisting 37 patients in each group. Out of 74 patients, 62 completed the study. Out of 12 patients who did not complete the study, 5 patients were lost during follow-up period and 7 patients discontinued treatment due to AEs. The mean age of the patients was 51 and 49years in the groups A and B respectively. There was no statistical difference in the baseline FPG, PPG, HbA1c, serum urea, serum creatinine, urine ACR and body weight between two groups.Conclusions: The study shows that metformin and vildagliptin have similar effect on glycaemic control, but vildagliptin exerts better Reno protective effect and there were no reports of serious adverse events.