title: Randomized controlled clinical trial of a combination therapy of vildagliptin plus an α-glucosidase inhibitor for patients with type II diabetes mellitus.
abstract: The aim of this study was to assess the efficacy of a combination therapy of vildagliptin plus an α-glucosidase inhibitor for patients with type II diabetes mellitus. Type II diabetic patients exhibiting poor glycemic control following α-glucosidase inhibitor treatment for at least two months were selected and randomly distributed into vildagliptin and placebo groups. The body weight, fasting blood glucose (FBG), postprandial glucose (PPG), glycated hemoglobin (HBA1c) and blood lipid levels and hepatorenal functions of the patients were determined before and 12 weeks after the trial. Following the trial, the FBG, PPG, HbA1c, cholesterol (CHOL) and triglyceride (TG) levels in the vildagliptin group were significantly decreased compared with the pretreatment levels (P<0.05), whereas only the PPG level in the placebo group decreased (P<0.05). The FBG, PPG and HbA1c levels in the vildagliptin group were markedly lower than those in the placebo group 12 weeks after the trial. A comparison of the body weights and hepatorenal functions before and after the trial or between groups did not show statistically significant differences. The combination therapy of vildagliptin plus an α-glucosidase inhibitor effectively reduced the FBG, PPG and HbA1c levels in patients without inducing weight gain or hepatorenal dysfunction. However, the therapy may have caused a reduction in the blood lipid levels.
authors.affiliation: Department of Endocrinology, The People's Hospital of Zhengzhou University (Henan Provincial People's Hospital), Zhengzhou, Henan 450003, P.R. China.
authors.forename: Yong
authors.initials: Y
authors.lastname: Su
authors.affiliation: Department of Endocrinology, The People's Hospital of Zhengzhou University (Henan Provincial People's Hospital), Zhengzhou, Henan 450003, P.R. China.
authors.forename: Ya-Li
authors.initials: YL
authors.lastname: Su
authors.affiliation: Department of Endocrinology, The People's Hospital of Zhengzhou University (Henan Provincial People's Hospital), Zhengzhou, Henan 450003, P.R. China.
authors.forename: Li-Fang
authors.initials: LF
authors.lastname: Lv
authors.affiliation: Department of Endocrinology, The People's Hospital of Zhengzhou University (Henan Provincial People's Hospital), Zhengzhou, Henan 450003, P.R. China.
authors.forename: Li-Min
authors.initials: LM
authors.lastname: Wang
authors.affiliation: Department of Endocrinology, The People's Hospital of Zhengzhou University (Henan Provincial People's Hospital), Zhengzhou, Henan 450003, P.R. China.
authors.forename: Quan-Zhong
authors.initials: QZ
authors.lastname: Li
authors.affiliation: Department of Endocrinology, The People's Hospital of Zhengzhou University (Henan Provincial People's Hospital), Zhengzhou, Henan 450003, P.R. China.
authors.forename: Zhi-Gang
authors.initials: ZG
authors.lastname: Zhao
keywords: blood lipid; body weight; hepatorenal function; type II diabetes mellitus; vildagliptin; α-glucosidase inhibitor