AN OPEN-LABEL, PROSPECTIVE, OBSERVATIONAL STUDY OF EFFICACY AND SAFETY OF GLIMEPIRIDE VERSUS VILDAGLIPTIN AS AN ADD-ON TO METFORMIN IN PATIENTS NOT ACHIEVING TARGET WITH METFORMIN MONOTHERAPY IN TYPE II DIABETES MELLITUS

Dr. Abhijit Das*, Dr. Agnimitra Bhattacharya, Dr. Sourav Chakrabarty, Dr. Saugata Ghosh, Dr. Apurba Kr. Mukherjee and Dr. Anup Kr. Das

ABSTRACT

Introduction: Diabetes is considered nowadays a global epidemic affecting more than 8% of adult population worldwide. Glimepiride and Vildagliptin are considered as standard second line agent after metformin as per American Diabetic Association guideline for the treatment of Type-II diabetes. Few studies have been done comparing the efficacy and safety of these two well prescribed drugs. Methodology: It was an open-label, prospective, parallel group, observational study. Type 2 diabetic patients (in whom glycemic control not achieved by Metformin alone) were enrolled. They were divided into two groups, group 1 getting Metformin + Vildagliptin and group 2 getting Metformin + Glimepiride. Fasting Plasma glucose, Post-prandial plasma glucose and HBA1C were recorded at baseline and after 6 months. Result and Discussion: A total 110 patients were included in the study. A total of 100 patients could be followed having 50 patients in each treatment arm. In both groups, FPG, PPPG and HBA1C levels decreased significantly (p value <0.0001) over 6 months. Vildagliptin-Metformin treatment showed an FPG, PPPG and HbA1c reduction comparable to that of the Glimepiride-Metformin treatment over a period of 6 months. Statistically significant wt gain is noted in the Group 2. Relative Risk of developing neuro-glycopenic symptoms in Group 2 was 8 fold compared to Group 1. In each groups, only 11 patients (22%) reached target HBA1C level. Conclusion: Vildagliptin-Metformin combination treatment offered comparable efficacy in terms of HbA1c, FPG & PPPG reduction but significantly less weight gain, and a lower risk of hypoglycemia in comparison to Glimepiride-Metformin combination. When safety is considered along with effectiveness, the Vildagliptin has an edge over glimepiride as second line agent.

Keywords: Type II Diabetes, Metformin, Vildagliptin, Glimepiride, Efficacy, Hypoglycemia, Weight gain.