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Chiglitazar Added to Metformin for Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT04807348
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : August 13, 2021
Sponsor:
Information provided by (Responsible Party):
Chipscreen Biosciences, Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Chiglitazar 32mg Drug: Chiglitazar 48mg Drug: Placebo Drug: Metformin Hydrochloride Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 519 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Double-blind Placebo Parallel Controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of Chiglitazar Added to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy (RECAM)
Actual Study Start Date : May 17, 2021
Estimated Primary Completion Date : October 15, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Chiglitazar sodium 32mg QD+metformin
Chiglitazar 32mg qd+metformin
 Drug: Chiglitazar 32mg
Administrated once daily
Other Names:
  • Bilessglu
  • CS038

Drug: Metformin Hydrochloride
most tolerable dose
Other Name: Glucophage
Experimental: Chiglitazar sodium 48 mg QD+metformin
Chiglitazar 48 mg qd+metformin
 Drug: Chiglitazar 48mg
Administrated once daily
Other Name: CS038

Drug: Metformin Hydrochloride
most tolerable dose
Other Name: Glucophage
Placebo Comparator: placebo+metformin
placebo+metformin
 Drug: Placebo
Placebo of Chiglitazar

Drug: Metformin Hydrochloride
most tolerable dose
Other Name: Glucophage


Outcome Measures
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Primary Outcome Measures :
  1. percentage of HbA1c change from baseline [ Time Frame: 24 weeks ]
    central lab test


Secondary Outcome Measures :
  1. Changes in blood fasting plasma glucose level from baseline [ Time Frame: 12 and 24 weeks ]
    central lab test

  2. Changes of HOMA-the IR value from baseline [ Time Frame: 12 and 24 weeks ]
    model calculated

  3. Changes of blood lipids level from baseline [ Time Frame: 12 and 24 weeks ]
    includeing TC, LDL-C, HDL-C, VLDL-C, non-HDL-C, TG, FFA, ApoA1, ApoB

  4. percentage of AEs [ Time Frame: 28 weeks ]
    safety

  5. number of participants with lab abnormality [ Time Frame: 24 weeks ]
    number or rate of founds in lab tests


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04807348


Contacts
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Contact: Linong Ji, Prof. 8610-88326666 plum_jj@sina.com

Locations
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Sponsors and Collaborators
Chipscreen Biosciences, Ltd.
Investigators
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Principal Investigator: Linong Ji, Prof. Peking University People's Hospital
More Information
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Additional Information:

Publications:
Linong Ji, Weihong Song, Hui Fang, Wei Li, Jianlin Geng, Yangang Wang, Lian Guo, Hanqing Cai, Tao Yang, Hongmei Li, Gangyi Yang, Qifu Li, Kuanzhi Liu, Shuying Li, Yanjun Liu, Fuyan Shi, Xinsheng Li, Xin Gao, Haoming Tian, Qiuhe Ji, Qing Su, Zhiguang Zhou, Wenbo Wang, Zunhai Zhou, Xuejun Li, Yancheng Xu, Zhiqiang Ning, Haixiang Cao, Desi Pan, He Yao, Xianping Lu, Weiping Jia, Efficacy and safety of chiglitazar, a novel peroxisome proliferator-activated receptor pan-agonist, in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, phase 3 trial (CMAP), Science Bulletin, Volume 66, Issue 15, 2021, Pages 1571-1580, ISSN 2095-9273, https://doi.org/10.1016/j.scib.2021.03.019.

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Responsible Party: Chipscreen Biosciences, Ltd.
ClinicalTrials.gov Identifier: NCT04807348    
Other Study ID Numbers: CGZ303
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs