Clinical trial NCT04807348: Chiglitazar Added to Metformin for Type 2 Diabetes
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Chipscreen Biosciences, Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-19
Enrollment: 533
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: percentage of HbA1c change from baseline
timeFrame: 24 weeks
Secondary outcomes:
measure: Changes in blood fasting plasma glucose level from baseline
timeFrame: 12 and 24 weeks
measure: Changes of HOMA-the IR value from baseline
timeFrame: 12 and 24 weeks
measure: Changes of blood lipids level from baseline
timeFrame: 12 and 24 weeks
measure: percentage of AEs
timeFrame: 28 weeks
measure: number of participants with lab abnormality
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Hefei Second People's Hospital
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
state: Anhui
city: Wuhu
country: China
facility: Yijishan Hospital of Wannan Medical College
state: Anhui
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Chang Gung Memorial Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing University First Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese People's Liberation Army Rocket Army Characteristic Medical Center
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Wanzhou
country: China
facility: Three Gorges Hospital Affiliated to Chongqing University
state: Chongqing
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Union Shenzhen Hospital of Huazhong University of Science and Technology
state: Guangdong
city: Hengshui
country: China
facility: Harrison International Peace Hospital
state: Hebei
city: Shijia Zhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Shijia Zhuang
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
city: Kaifeng
country: China
facility: Huaihe Hospital of Henan University
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Luoyang
country: China
facility: The Third People's Hospital of Luoyang City
state: Henan
city: Xinxiang
country: China
facility: Xinxiang Central Hospital
state: Henan
city: Chenzhou
country: China
facility: The First People's Hospital of Chenzhou City
state: Hunan
city: Yueyang
country: China
facility: Yueyang Second People's Hospital
state: Hunan
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
state: Hunan
city: Baotou
country: China
facility: Inner Mongolia Baotou Steel Hospital
state: Inner Mongolia
city: Huaian
country: China
facility: The First People's Hospital of Huai'an
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Yifu Hospital Affiliated to Nanjing Medical University
state: Jiangsu
city: Xuzhou
country: China
facility: Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Harbin
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Jilin
city: Harbin
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Panjin
country: China
facility: Panjin Liaoyou Baoshihua Hospital
state: Liaoning
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical College, Shandong Province
state: Shandong
city: Qingdao
country: China
facility: Qingdao University Hospital
state: Shandong
city: Shanghai
country: China
facility: Gongli Hospital, Pudong New Area, Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Minhang District Central Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Seventh People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Yuncheng
country: China
facility: Central Hospital of Yuncheng City, Shanxi Province
state: Shanxi
city: Tangshan
country: China
facility: Tangshan Workers' Hospital
state: Tianjin
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zhejiang
Study officials:
affiliation: Peking University People's Hospital
name: Linong Ji, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ji L, Song W, Fang H, Li W, Geng J, Wang Y, Guo L, Cai H, Yang T, Li H, Yang G, Li Q, Liu K, Li S, Liu Y, Shi F, Li X, Gao X, Tian H, Ji Q, Su Q, Zhou Z, Wang W, Zhou Z, Li X, Xu Y, Ning Z, Cao H, Pan D, Yao H, Lu X, Jia W. 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). Sci Bull (Beijing). 2021 Aug 15;66(15):1571-1580. doi: 10.1016/j.scib.2021.03.019. Epub 2021 Mar 23.
citation: Jia W, Ma J, Miao H, Wang C, Wang X, Li Q, Lu W, Yang J, Zhang L, Yang J, Wang G, Zhang X, Zhang M, Sun L, Yu X, Du J, Shi B, Xiao C, Zhu D, Liu H, Zhong L, Xu C, Xu Q, Liang G, Zhang Y, Li G, Gu M, Liu J, Yuan G, Yan Z, Yan D, Ye S, Zhang F, Ning Z, Cao H, Pan D, Yao H, Lu X, Ji L. Chiglitazar monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomized, double-blind, phase 3 trial (CMAS). Sci Bull (Beijing). 2021 Aug 15;66(15):1581-1590. doi: 10.1016/j.scib.2021.02.027. Epub 2021 Feb 16.