Chiglitazar Added to Metformin for Type 2 Diabetes

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: Chiglitazar 32mg; Drug: Chiglitazar 48mg; Drug: Metformin Hydrochloride

• Registration Number: NCT04807348
• Lead Sponsor: Chipscreen Biosciences, Ltd.

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.

Study Timeline

• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-19
• Study Start: 2021-07-06
• Primary Completion: 2023-02-10
• Study Completion: 2023-02-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 533

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo+metformin	Placebo	placebo+metformin
placebo+metformin	Metformin Hydrochloride	placebo+metformin
Chiglitazar sodium 32mg QD+metformin	Chiglitazar 32mg	Chiglitazar 32mg qd+metformin
Chiglitazar sodium 48 mg QD+metformin	Metformin Hydrochloride	Chiglitazar 48 mg qd+metformin
Chiglitazar sodium 48 mg QD+metformin	Chiglitazar 48mg	Chiglitazar 48 mg qd+metformin
Chiglitazar sodium 32mg QD+metformin	Metformin Hydrochloride	Chiglitazar 32mg qd+metformin

Primary Outcome Measures

Name	Time	Method
percentage of HbA1c change from baseline	24 weeks	central lab test

Secondary Outcome Measures

Name	Time	Method
Changes of HOMA-the IR value from baseline	12 and 24 weeks	model calculated
Changes in blood fasting plasma glucose level from baseline	12 and 24 weeks	central lab test
percentage of AEs	28 weeks	safety
number of participants with lab abnormality	24 weeks	number or rate of founds in lab tests
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

Trial Locations

Locations (50)

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

Beijing Chaoyang Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Luhe Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Tongren Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Tsinghua Chang Gung Memorial Hospital; 🇨🇳 Beijing, Beijing, China

Beijing University First Hospital; 🇨🇳 Beijing, Beijing, China

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