A randomized controlled clinical trial of combination therapy for type 2 diabetes by vildagliptin, metformin, and α-glucosidase inhibitor

Abstract

This study aims to evaluate the efficacy and safety of vildagliptin combined with metformin and α-glucosidase inhibitors for treatment of type 2 diabetes. The type 2 diabetic patients with poor blood sugar control after a combination treatment by metformin and α-glucosidase inhibitor for at least two months were randomly assigned to receive vildagliptin or placebo (100 mg/day for 2 times) on the basis of the original treatment. The relevant indicators of the patients before and after the test for 12 weeks were detected. We totally chose 490 cases of subjects who were in Henan Provincial People’s Hospital from February,2013 to July,2013. Compared with the data before the test, the glycated hemoglobin (HbA1c) changed from 8.86 ± 1.820 to 6.74 ± 1.256 % and fasting blood glucose (FBG), postprandial blood glucose (PPG), and alanine aminotransferase (ALT) in the vildagliptin group significantly decreased; the difference was statistically significant (P < 0.05). The differences of the index in the placebo group were not statistically significant (P > 0.05). HbA1c in the vildagliptin group, 12 weeks after the test, was significantly lower than those in the placebo group with a comparison by 6.74 ± 1.256 and 8.20 ± 1.180 %, as well as FBG, PPG, ALT, and aspartate aminotransferase (AST); the difference was statistically significant (P < 0.05). Whether the comparisons were performed before and after treatment or between the two groups, the changes of the subject’s body weight and blood lipids had no statistically significant differences (P > 0.05). Vildagliptin combined with metformin and α-glucosidase inhibitors can efficiently reduce the FBG, PPG, and HbA1c of the patients without gaining weight and may have a protective effect on the liver.