Chiglitazar Added to Metformin for Type 2 Diabetes

Status:

COMPLETED

Chiglitazar Added to Metformin for Type 2 Diabetes

Lead Sponsor:

Chipscreen Biosciences, Ltd.

Conditions:

Type 2 Diabetes

Eligibility:

All Genders

18-75 years

Phase:

PHASE3

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...

Eligibility Criteria

Inclusion

) 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

) 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 \[ Calculated eGFR\<60 ml/ ( min\*1.73m2 ) using CKD - EPI formula \];
) 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.

Key Trial Info

Start Date :

July 6 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 10 2023

Estimated Enrollment :

533 Patients enrolled

Trial Details

Trial ID

NCT04807348

Start Date

July 6 2021

End Date

February 10 2023

Last Update

July 15 2024

Active Locations (50)

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Page 1 of 13 (50 locations)

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

Trial Details

Trial ID

NCT04807348

Start Date

July 6 2021

End Date

February 10 2023

Last Update

July 15 2024

Status: