The purpose of the trial is to evaluate the effect of Chiglitazar added to metformin to type 2 diabetes Inadequately controlled with metformin Monotherapy.
This clinical trial is a multi-center, randomized, double-blind, placebo parallel control design, and uses superiority test to determine whether the experimental group is superior to the control group in terms of main efficacy endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
533
Administrated once daily
Administrated once daily
Placebo of Chiglitazar
percentage of HbA1c change from baseline
central lab test
Time frame: 24 weeks
Changes in blood fasting plasma glucose level from baseline
central lab test
Time frame: 12 and 24 weeks
Changes of HOMA-the IR value from baseline
model calculated
Time frame: 12 and 24 weeks
Changes of blood lipids level from baseline
includeing TC, LDL-C, HDL-C, VLDL-C, non-HDL-C, TG, FFA, ApoA1, ApoB
Time frame: 12 and 24 weeks
percentage of AEs
safety
Time frame: 28 weeks
number of participants with lab abnormality
number or rate of founds in lab tests
Time frame: 24 weeks
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most tolerable dose
Hefei Second People's Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tsinghua Chang Gung Memorial Hospital
Beijing, Beijing Municipality, China
Beijing University First Hospital
Beijing, Beijing Municipality, China
...and 40 more locations