Randomized,double-blind,double-dummy,controlled clinical trial of pioglitazone /metformin in the treatment of type 2 diabetes
10.3969/j.issn.1001-6821.2009.06.001
- VernacularTitle:吡格列酮二甲双胍片治疗2型糖尿病的多中心随机双盲平行对照临床试验
- Author:
Hong-Lin HU
1
;
Chang-Jiang WANG
;
Mu-Xun ZHANG
;
Sheng-Li YAN
;
Jun-Jiang LIU
;
Lv-Yun ZHU
;
Yong HE
;
Ya GAO
Author Information
1. 安徽医科大学附属第一医院
- Keywords:
type 2 diabetes mellitus;
pioglitazone /metformin;
metform in hydrochloride;
pioglitazone hydrochloride
- From:
The Chinese Journal of Clinical Pharmacology
2009;25(6):483-486
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of pioglitazone /metformin hydrochloride in the treatment of type 2 diabetes mellitus patients. Methods A randomized, double-blind, metformin and pioglitazone hydrochloride-controlled, and multicenter clinical trial was conducted. A total of 240 patients with type 2 diabetes mellitus were enrolled in this study, in which 120 patients received pioglitazone/ metformin, and 120 patients received metformin and pioglitazone. Result Comparing to the baseline, the fasting blood glucose ( FBG) , 2 h postprandial blood glucose (P2hBG) and HbAlc levels in tow groups were significantly reduced after 16-week treatment ( P < 0. 01 ) . In pioglitazone/metformin group, the mean reductions of FBG, P2hBG and HbAlc levels were (1. 92 ± 1. 77 ) mmol · L~(-1), ( 2. 49 ± 3. 13 ) mmol · L~(-1), (1. 27 ± 1. 45 ) % respectively. In metformin and pioglitazone group, the mean reductions of FBG, P2hBG and HbAlc levels were (2. 24 ±2. 11) mmol · L~(-1), (2. 89 ± 3. 71) mmol · L~(-1), ( 1. 49 ± 1. 52)% respectively. The differences in reductions of FBG, P2hBG and HbAlc level between the groups were not statistically significant. The incidence of adverse drug reaction in two groups was similar (10% vs 12%). Conclusion This result provides an efficacy and safety of pioglitazone /metformin in the treatment of type 2 diabetes mellitus.
