Publication:

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

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.