A randomized controlled clinical trial of vildagliptin plus metformin combination therapy in patients with type II diabetes mellitus.

The aim of the present study was to assess the efficacy and safety of vildagliptin plus metformin combination therapy in patients with type II diabetes mellitus. Type II diabetic patients with poor glycemic control following at least three months of metformin treatment were selected and randomized into two groups. Vildagliptin or placebo was administered with metformin. Body weight, fasting blood glucose (FBG), postprandial glucose (PPG), glycated hemoglobin (HbA1c), blood lipid and hepatorenal function levels were analyzed in the patients prior to and 24-weeks after the trial. FBG, PPG and HbA1c levels of the patients in the vildagliptin group significantly decreased following the trial, whereas no statistically significant differences were observed in the various indicators of the placebo group prior to and following the trial. The FBG, PPG and HbA1c levels in the vildagliptin group were significantly lower compared with the placebo group 24-weeks after the trial. Comparisons of body weight, blood lipid and hepatorenal function between the groups prior to and following the trial exhibited no statistically significant differences. Therefore, vildagliptin plus metformin combination therapy effectively reduced FBG, PPG and HbA1c levels in patients with no risk of weight gain or hepatorenal dysfunction.