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Chiglitazar Added to Metformi...

Chiglitazar Added to Metformin for Type 2 Diabetes

Last Updated: 2024-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

533 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-06

Study Completion Date

2023-02-10

Brief Summary

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The purpose of the trial is to evaluate the effect of Chiglitazar added to metformin to type 2 diabetes Inadequately controlled with metformin Monotherapy.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Chiglitazar sodium 32mg QD+metformin

Chiglitazar 32mg qd+metformin

Group Type EXPERIMENTAL

Chiglitazar 32mg

Intervention Type DRUG

Administrated once daily

Metformin Hydrochloride

Intervention Type DRUG

most tolerable dose

Chiglitazar sodium 48 mg QD+metformin

Chiglitazar 48 mg qd+metformin

Group Type EXPERIMENTAL

Chiglitazar 48mg

Intervention Type DRUG

Administrated once daily

Metformin Hydrochloride

Intervention Type DRUG

most tolerable dose

placebo+metformin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo of Chiglitazar

Metformin Hydrochloride

Intervention Type DRUG

most tolerable dose

Interventions

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Chiglitazar 32mg

Administrated once daily

Intervention Type DRUG

Chiglitazar 48mg

Administrated once daily

Intervention Type DRUG

Placebo

Placebo of Chiglitazar

Intervention Type DRUG

Metformin Hydrochloride

most tolerable dose

Intervention Type DRUG

Other Intervention Names

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Bilessglu CS038 Bilessglu CS038 Chiglitazar simulator Glucophage

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linong Ji, Prof.

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Hefei Second People's Hospital

Hefei, Anhui, China

Site Status

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status