Chiglitazar Added to Metformin for Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 533
- ) Provide a signed and dated informed consent form;
- ) Men and women aged ≥ 18 years and ≤ 75 years;
- ) According to the World Health Organization ( the WHO ) 1999 criteria for the diagnosis of type 2 diabetes;
- ) 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;
- ) The local HbA1c value during the screening period: 7.5% ≤ HbA1c ≤ 11% ;
- ) The HbA1c value of the central laboratory before randomization: 7.0% ≤ HbA1c ≤ 10.5% ;
- ) BMI ≥ 18.5 kg/m2 and ≤ 35 kg/m 2 ;
- ) Fasting C- peptide ≥ 0.5 nmol/L ;
- ) 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.
- ) Type 1 diabetes;
- ) Pregnancy or lactation;
- ) The New York Heart Association (NYHA ) defines congestive heart failure as grade III or IV ;
- ) 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;
- ) Suffered from malignant tumors (except cured basal cell carcinoma) within 5 years before screening;
- ) Edema of lower limbs or edema of the whole body;
- ) Moderate to severe renal insufficiency [ Calculated eGFR<60 ml/ ( min*1.73m2 ) using CKD - EPI formula ];
- ) urinary albumin-to-creatinine ratio of > 300 mg /g;
- ) Triglyceride> 5.6 mmol /L;
- ) 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
- ) 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;
- ) 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 ;
- ) History of illegal drug abuse within 12 months before screening ;
- ) Participated in other clinical trials within 90 days before screening ;
- ) Donated whole blood, plasma, or platelets within 3 months before screening.
- ) 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;
- ) 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)
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Luhe Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Harrison International Peace Hospital
🇨🇳Hengshui, Hebei, China
Shanghai Minhang District Central Hospital
🇨🇳Shanghai, Shanghai, China
Hefei Second People's Hospital
🇨🇳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 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
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Three Gorges Hospital Affiliated to Chongqing University
🇨🇳Wanzhou, Chongqing, China
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Union Shenzhen Hospital of Huazhong University of Science and Technology
🇨🇳Shenzhen, Guangdong, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
The Second Hospital of Hebei Medical University
🇨🇳Shijia Zhuang, Hebei, China
The Third Hospital of Hebei Medical University
🇨🇳Shijia Zhuang, Hebei, 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
Xinxiang Central Hospital
🇨🇳Xinxiang, Henan, China
The First People's Hospital of Chenzhou City
🇨🇳Chenzhou, Hunan, China
Yueyang Second People's Hospital
🇨🇳Yueyang, Hunan, China
Zhuzhou Central Hospital
🇨🇳Zhuzhou, Hunan, China
Inner Mongolia Baotou Steel Hospital
🇨🇳Baotou, Inner Mongolia, China
The First People's Hospital of Huai'an
🇨🇳Huaian, Jiangsu, 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
Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, 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
Panjin Liaoyou Baoshihua Hospital
🇨🇳Panjin, Liaoning, 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
Qingdao University Hospital
🇨🇳Qingdao, Shandong, China
Gongli Hospital, Pudong New Area, Shanghai
🇨🇳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
Central Hospital of Yuncheng City, Shanxi Province
🇨🇳Yuncheng, Shanxi, China
Tangshan Workers' Hospital
🇨🇳Tangshan, Tianjin, China
Huzhou Central Hospital
🇨🇳Huzhou, Zhejiang, China