Chiglitazar Added to Metformin for Type 2 Diabetes

  • End date
    Mar 31, 2023
  • participants needed
  • sponsor
    Chipscreen Biosciences, Ltd.
Updated on 29 April 2022
hemoglobin a1c


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.

Condition Type 2 Diabetes
Treatment Placebo, Metformin Hydrochloride, Chiglitazar 32mg, Chiglitazar 48mg
Clinical Study IdentifierNCT04807348
SponsorChipscreen Biosciences, Ltd.
Last Modified on29 April 2022


Yes No Not Sure

Inclusion Criteria

) Provide a signed and dated informed consent form
) Men and women aged ≥ 18 years and ≤ 75 years
) According to the World Health Organization ( the WHO ) 1999 criteria for the diagnosis of type 2 diabetes
) 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
) The local HbA1c value during the screening period: 7.5% ≤ HbA1c ≤ 11%
) The HbA1c value of the central laboratory before randomization: 7.0% ≤ HbA1c ≤ 10.5%
) BMI ≥ 18.5 kg/m2 and ≤ 35 kg/m 2
) Fasting C- peptide ≥ 0.5 nmol/L
) 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

) Type 1 diabetes
) Pregnancy or lactation
) The New York Heart Association (NYHA ) defines congestive heart failure as grade III or IV
) 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
) Suffered from malignant tumors (except cured basal cell carcinoma) within 5 years before screening
) Edema of lower limbs or edema of the whole body
) Moderate to severe renal insufficiency [ Calculated eGFR<60 ml/ ( min1.73m2 ) using CKD - EPI formula ]
) urinary albumin-to-creatinine ratio of > 300 mg /g
) Triglyceride> 5.6 mmol /L
) 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
) 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
) 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
) History of illegal drug abuse within 12 months before screening
) Participated in other clinical trials within 90 days before screening
) Donated whole blood, plasma, or platelets within 3 months before screening
) 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
) The investigator judged that it is not suitable to participate in this clinical trial
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