A multicentric, randomized, open-label study on comparison of pancreatic beta cell recovery and preservation in type 2 diabetic patients treated with DPP-4 Inhibitor (Vildagliptin) and Metformin

Abstract

Introduction: Type 2 diabetes (T2D) is a major chronic metabolic disorder. Insulin resistance and pancreatic islet beta cell defect are the characteristic pathophysiologic findings in T2D. Aim: To compare the effect of Vildagliptin versus Metformin on pancreatic beta cell function for two years among newly diagnosed, non-obese Asian Indians with Type 2 diabetes. Method: We randomised 203 (104 men 99 women) newly diagnosed type 2 diabetes patients (mean age 47.0 ± 8.1 years, body mass index 23.7 ± 1.4 kg/m2) into two groups. Group 1 treated with Metformin (n = 100), and Group 2 was treated with Vildagliptin (n = 103). The primary outcome measure was to compare the effects of Vildagliptin versus Metformin on pancreatic beta cell function in type 2 diabetes patients at two years. Results: Among the 100 patients randomised to Metformin group, 51 % required only monotherapy and 49 % required the rescue medication. Among the 103 persons, in the Vildagliptin group, 42.7 % required only monotherapy, and 57.3 % required the rescue medication. At the end of the study, there were 12.3 % dropouts and 11.8 % excluded due to lack of glycemic control. The response rate was 87.7 % with a mean duration of follow-up of 80.5 weeks. Totally 36 % of participants in the Metformin group and 27.2 % in Vildagliptin group completed the study with monotherapy. The percentage of patients requiring rescue medication in both groups was similar. However, at 3rd month itself, a higher percentage of patients on Vildagliptin (32%) required the rescue drug when compared with Metformin (18%, and#967;2 = 3.99, p = 0.046). The median duration of monotherapy was 48 weeks (25 70) for both groups. Conclusion: Both Metformin and Vildagliptin have protective effects on the beta cell function, reduce insulin resistance and glycemic levels. Metformin increased insulin sensitivity also. Higher C-peptide and lower HbA1c values at baseline predicted better glycemic control with Vildagliptin. Lower baseline HbA1c predicted good glycemic control with Metformin.