The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with placebo.
The efficacy and safety will be compared between Chiglitazar and placebo after treatment of 24 weeks. The long term efficacy and safety of Chiglitazar will be evaluated after 52 weeks treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
535
Take orally
Take orally
Change in HbA1c from baseline after 24 weeks of treatment
The change of HbA1c at week 24 from baseline
Time frame: 24 weeks
Change in HbA1c from baseline for patients with a baseline HbA1c >=8.5%
The change of HbA1c at week 24 from baseline for patients with a HbA1c \>=8.5% at baseline
Time frame: 24 weeks
Change in HbA1c from baseline in patients with a baseline HbA1c < 8.5%
The change of HbA1c at week 24 from baseline for patients with a HbA1c \< 8.5% at baseline
Time frame: 24 weeks
Change in HbA1c from baseline
The change of HbA1c at week 12 from baseline
Time frame: 12 weeks
Change in HbA1c from baseline
The change of HbA1c at week 52 from baseline
Time frame: 52 weeks
Percentage of patients that attained target HbA1c <7.0%
Percentage of patients whose HbA1c at week 24 are \< 7.0%
Time frame: 24 weeks
Percentage of patients whose HbA1c lowered by at least 0.5%
Percentage of patients whose change of HbA1c at week 24 from baseline are \>= 0.5%
Time frame: 24 weeks
Change in fasting plasma glucose from baseline
The change of fasting plasma glucose at week 12 and 24 from baseline
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Peking University Shougang Hospital
Beijing, Beijing Municipality, China
China Meitan General Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
The 306th Hospital of PLA
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
Cangzhou's Central Hospital
Cangzhou, Hebei, China
Harrison International Peace Hospital
Hengshui, Hebei, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
...and 16 more locations
Time frame: 12,24 and 52 weeks
Change in 2-h postprandial glucose (2hPPG) from baseline
The change of 2-h postprandial glucose (2hPPG) at week 12, 24 and 52 from baseline
Time frame: 12, 24 and 52 weeks
Change in total cholesterol (TC) from baseline
The change of total cholesterol (TC) at week 12, 24 and 52 from baseline
Time frame: 12, 24 and 52 weeks
Change in triglyceride from baseline
The change of triglyceride at week 12, 24 and 52 from baseline
Time frame: 12,24 and 52 weeks
Change in high density lipoprotein cholesterol (HDL-C)from baseline
The change of high density lipoprotein cholesterol (HDL-C) at week week 12, 24 and 52 from baseline
Time frame: 12, 24 and 52 weeks
Change in low density proprotein cholesterol (LDL-C) from baseline
The change of low density lipoprotein cholesterol (LDL-C) at week 12, 24 and 52 from baseline
Time frame: 12, 24 and 52 weeks
Change in free fatty acid (FFA) from baseline
The change of free fatty acid (FFA) at week 12, 24 and 52 from baseline
Time frame: 12, 24 and 52 weeks
Change in fasting plasma insulin from baseline
The change of fasting plasma insulin at week 12, 24 and 52 from baseline
Time frame: 12, 24 and 52 weeks
Insulin sensitivity assessed by the homeostatic model assessment (HOMA) at 12,24 and 52 weeks, compared with that of baseline
The change of insulin sensitivity at week 12, 24 and 52 from baseline
Time frame: 12, 24 and 52 weeks
Change in blood pressure from baseline
The change of blood pressure at week 24 from baseline
Time frame: 24 weeks
Percentage of patients who use rescue therapy
The percentage of patients who use rescue therapy during the 52 weeks of treatment
Time frame: 52 weeks