Chiglitazar Added to Metformin for Type 2 Diabetes

Type 2 Diabetes Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04807348
• Other study ID #: CGZ303
• Status: Recruiting
• Phase: Phase 3
• Start date: May 17, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2022
• Source: Chipscreen Biosciences, Ltd.
• Contact: Linong Ji, Prof.
• Phone: 8610-88326666
• Email: plum_jj[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 519
• Est. completion date: March 31, 2023
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Chiglitazar 32mg
Administrated once daily
• Chiglitazar 48mg
Administrated once daily
• Placebo
Placebo of Chiglitazar
• Metformin Hydrochloride
most tolerable dose

Locations

Country	Name	City	State
China	Inner Mongolia Baotou Steel Hospital	Baotou	Inner Mongolia
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	Chinese People's Liberation Army Rocket Army Characteristic Medical Center	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing
China	The First People's Hospital of Chenzhou City	Chenzhou	Hunan
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The First Hospital of Jilin University	Harbin	Jilin
China	The Fourth Affiliated Hospital of Harbin Medical University	Harbin	Jilin
China	The Second Hospital of Jilin University	Harbin	Jilin
China	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	Harrison International Peace Hospital	Hengshui	Hebei
China	The First People's Hospital of Huai'an	Huaian	Jiangsu
China	Huzhou Central Hospital	Huzhou	Zhejiang
China	Jinan Central Hospital	Jinan	Shandong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Affiliated Hospital of Jining Medical College, Shandong Province	Jining	Shandong
China	Huaihe Hospital of Henan University	Kaifeng	Henan
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	The Third People's Hospital of Luoyang City	Luoyang	Henan
China	Jiangsu Provincial People's Hospital	Nanjing	Jiangsu
China	Nanjing First Hospital	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Yifu Hospital Affiliated to Nanjing Medical University	Nanjing	Jiangsu
China	Panjin Liaoyou Baoshihua Hospital	Panjin	Liaoning
China	Qingdao University Hospital	Qingdao	Shandong
China	Gongli Hospital, Pudong New Area, Shanghai	Shanghai	Shanghai
China	Shanghai Minhang District Central Hospital	Shanghai	Shanghai
China	Shanghai Pudong Hospital	Shanghai	Shanghai
China	Shanghai Seventh People's Hospital	Shanghai	Shanghai
China	Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	Union Shenzhen Hospital of Huazhong University of Science and Technology	Shenzhen	Guangdong
China	The Second Hospital of Hebei Medical University	Shijia Zhuang	Hebei
China	The Third Hospital of Hebei Medical University	Shijia Zhuang	Hebei
China	Tangshan Workers' Hospital	Tangshan	Tianjin
China	Three Gorges Hospital Affiliated to Chongqing University	Wanzhou	Chongqing
China	Yijishan Hospital of Wannan Medical College	Wuhu	Anhui
China	Xinxiang Central Hospital	Xinxiang	Henan
China	Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Yueyang Second People's Hospital	Yueyang	Hunan
China	Central Hospital of Yuncheng City, Shanxi Province	Yuncheng	Shanxi
China	Zhuzhou Central Hospital	Zhuzhou	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Chipscreen Biosciences, Ltd.

Country where clinical trial is conducted

China, 

References & Publications (2)

Guo S, Lai C, Wu C, Cen G; Alzheimer's Disease Neuroimaging Initiative. Conversion Discriminative Analysis on Mild Cognitive Impairment Using Multiple Cortical Features from MR Images. Front Aging Neurosci. 2017 May 18;9:146. doi: 10.3389/fnagi.2017.00146. eCollection 2017. Erratum in: Front Aging Neurosci. 2017 Sep 05;9:293. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of HbA1c change from baseline	central lab test	24 weeks
Secondary	Changes in blood fasting plasma glucose level from baseline	central lab test	12 and 24 weeks
Secondary	Changes of HOMA-the IR value from baseline	model calculated	12 and 24 weeks
Secondary	Changes of blood lipids level from baseline	includeing TC, LDL-C, HDL-C, VLDL-C, non-HDL-C, TG, FFA, ApoA1, ApoB	12 and 24 weeks
Secondary	percentage of AEs	safety	28 weeks
Secondary	number of participants with lab abnormality	number or rate of founds in lab tests	24 weeks

External Links

•   Chiglitazar monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomized, double-blind, phase 3 trial (CMAS)
•   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)