The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with Sitagliptin.
The efficacy and safety will be compared between Chiglitazar and Sitagliptin after treatment of 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
740
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 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
The change of HbA1c at week 12 from baseline
Time frame: 12 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 24d 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
Time frame: 12 and 24 weeks
Change in 2-h postprandial glucose (2hPPG) from baseline
The change of 2-h postprandial glucose (2hPPG) at week 12 and 24 from baseline
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Anhui Provincial Hospital
Hefei, Anhui, China
The First Hospital Affiliated to Anhui Medical University
Hefei, Anhui, China
Fuwai Hospital
Beijing, Beijing Municipality, China
The General Hospital of the Chinese People's Armed Police Forces
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
The Second Artillery General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Beijing Tongren Hospital Affiliated to Capital Medical Universtiy
Beijing, Beijing Municipality, China
The Third Hospital Affiliated to Guangzhou Medical College
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
...and 27 more locations
Time frame: 12 and 24 weeks
Change in total cholesterol (TC) from baseline
The change of total cholesterol (TC) at week 12 and 24 from baseline
Time frame: 12 and 24 weeks
Change in triglyceride from baseline
The change of triglyceride at week 12 and 24 from baseline
Time frame: 12 and 24 weeks
Change in high density lipoprotein cholesterol (HDL-C) from baseline
The change of high density lipoprotein cholesterol (HDL-C) at week 12 and 24 from baseline
Time frame: 12 and 24 weeks
Change in low density proprotein cholesterol (LDL-C) from baseline
The change of low density lipoprotein cholesterol (LDL-C) at week 12 and 24 from baseline
Time frame: 12 and 24 weeks
Change in free fatty acid (FFA) from baseline
The change of free fatty acid (FFA) at week 12 and 24 from baseline
Time frame: 12 and 24 weeks
Change in fasting plasma insulin from baseline
The change of fasting plasma insulin at week 12 and 24 from baseline
Time frame: 12 and 24 weeks
Insulin sensitivity assessed by the homeostatic model assessment (HOMA) at 12 and 24 weeks, compared with that of baseline
The change of insulin sensitivity at week 12 and 24 from baseline
Time frame: 12 and 24 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 discontinue the trial due to hyperglycemia
The percentage of patients who discontinue the trial due to hyperglycemia during the 24 weeks of treatment
Time frame: 24 weeks