chiglitazar added to metformin for type 2 diabetes

Conditions: Type 2 Diabetes

Summary: 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.

Eligibility criteria:
inclusion criteria: 1. ) provide a signed and dated informed consent form; 2. ) men and women aged ≥ 18 years and ≤ 75 years; 3. ) according to the world health organization ( the who ) 1999 criteria for the diagnosis of type 2 diabetes; 4. ) after metformin stable dose monotherapy (≥1500 mg/day or maximum tolerated dose, but the maximum tolerated dose not \< l000 mg/day) for at least 8 weeks; 5. ) the local hba1c value during the screening period: 7.5% ≤ hba1c ≤ 11% ; 6. ) the hba1c value of the central laboratory before randomization: 7.0% ≤ hba1c ≤ 10.5% ; 7. ) bmi ≥ 18.5 kg/m2 and ≤ 35 kg/m 2 ; 8. ) fasting c- peptide ≥ 0.5 nmol/l ; 9. ) women of childbearing potential ( wocbp ) should take reliable contraceptive measures at least 1 month before the screening, during the entire trial, and within 3 months after completing the trial; male subjects should take reliable contraceptive measures to avoid making their sexual partners to pregnant during the entire trial and within 3 months after the trial. exclusion criteria: 1. ) type 1 diabetes; 2. ) pregnancy or lactation; 3. ) the new york heart association (nyha ) defines congestive heart failure as grade iii or iv ; 4. ) significant history of cardiovascular and cerebrovascular diseases within 6 months before screening, defined as myocardial infarction, coronary artery bypass graft or angioplasty, valvular disease or repair, unstable angina, transient brain ischemic attack, or cerebrovascular accident; 5. ) suffered from malignant tumors (except cured basal cell carcinoma) within 5 years before screening; 6. ) edema of lower limbs or edema of the whole body; 7. ) moderate to severe renal insufficiency \[ calculated egfr\<60 ml/ ( min\*1.73m2 ) using ckd - epi formula \]; 8. ) urinary albumin-to-creatinine ratio of \> 300 mg /g; 9. ) triglyceride\> 5.6 mmol /l; 10. ) active liver disease and /or obvious liver function abnormalities, defined as ast\>2.5 times the upper limit of normal value and/or alt\>2.5 times the upper limit of normal value and/or total bilirubin \>1.5 times the normal value upper limit 11. ) clinically significant arrhythmias in the electrocardiogram examination and treatment or intervention are required. the investigator judges that it is not suitable to participate in this clinical trial; 12. ) human immunodeficiency virus (hiv) antibody-positive; treponema pallidum antibody positive; positive hepatitis b surface antigen and hbv dna quantification values were higher than the upper; hcv antibodies and hcv rna quantification values were higher than the upper ; 13. ) history of illegal drug abuse within 12 months before screening ; 14. ) participated in other clinical trials within 90 days before screening ; 15. ) donated whole blood, plasma, or platelets within 3 months before screening. 16. ) before randomization, the investigator judged that the subjects had poor compliance with the study protocol or drug treatment, defined as the subjects taking less than 80% or more than 120% of the prescribed dose of chiglitazar/ placebo or metformin; 17. ) the investigator judged that it is not suitable to participate in this clinical trial.