Evaluation of vildagliptin and fixed dose combination of vildagliptin and metformin on glycemic control and insulin dose over 3 months in patients with type 2 diabetes mellitus

OBJECTIVE: Addition of vildagliptin to ongoing insulin therapy may help in terms of overall glycemic control as well as reduction in dose of insulin and weight. This study sought to evaluate the effect of vildagliptin and fixed dose combination (FDC) of vildagliptin and metformin in patients in ongoing insulin therapy for Type 2 diabetes mellitus. MATERIALS AND METHODS: This was an open label, prospective, non-randomised, multicentric observational study. In this study 400 patients with T2DM on insulin were enrolled and allocated with the treatment of vildagliptin 50 mg in monotherapy and FDC of vildagliptin 50 mg and metformin strengths as 500/ 850 / 1000 mg. Baseline investigations included fasting blood glucose (FBG) and post prandial plasma glucose (PPPG) Estimation and glycosylated haemoglobin (HbA1c). RESULTS: The combined analysis was carried out on 300 completed patients in this study, who were treated with vildagliptin or FDC of vildagliptin and metformin. The difference in mean value of insulin dose (MID) showed a highly significant decrease (P <0.0001) from baseline to end of the treatment i.e. from 36.26 ± 18.21 to 26.87 ± 16.49 IU. A highly significant decrease (P <0.0001) in FBG from 194.94 ± 56.19 to 124.93 ± 30.11 mg/dl was observed. Similarly PPPG showed a highly significant (P <0.0001) decrease from baseline to end of the treatment i.e. from 287.60 mg/dl to 172.05 mg/dl and there was highly significant (P <0.0001) decrease in HbA1c i.e. from 9.01% to 7.65% respectively. At the same time, highly significant decrease (P <0.0001) in mean weight also observed from baseline to end of the treatment i.e. from 71.23 ± 11.06 kg to 70.06 ± 10.62 Kg. CONCLUSION: Addition of vildagliptin and FDC of vildagliptin and metformin is an effective strategy in glycemic control, reduction in dose of insulin and weight of patients suffering with T2DM.