Type 2 Diabetes
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGChiglitazar 32mg
Administrated once daily
DRUGChiglitazar 48mg
Administrated once daily
DRUGPlacebo
Placebo of Chiglitazar
DRUGMetformin Hydrochloride
most tolerable dose
Sponsors
Chipscreen Biosciences, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of HbA1c change from baseline | 24 weeks | central lab test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood fasting plasma glucose level from baseline | 12 and 24 weeks | central lab test |
| Changes of HOMA-the IR value from baseline | 12 and 24 weeks | model calculated |
| Changes of blood lipids level from baseline | 12 and 24 weeks | includeing TC, LDL-C, HDL-C, VLDL-C, non-HDL-C, TG, FFA, ApoA1, ApoB |
| percentage of AEs | 28 weeks | safety |
| number of participants with lab abnormality | 24 weeks | number or rate of founds in lab tests |
Countries
China
Outcome results
None listed