Study of Chiglitazar Compare With Placebo in Type 2 Diabetes Patients
- Registration Number
- NCT02121717
- Lead Sponsor
- Chipscreen Biosciences, Ltd.
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with placebo.
- Detailed Description
The efficacy and safety will be compared between Chiglitazar and placebo after treatment of 24 weeks. The long term efficacy and safety of Chiglitazar will be evaluated after 52 weeks treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 535
- Meet the WHO Diagnostic Criteria for Type 2 Diabetes (published on 1999);
- HbA1c≥ 7.5% and ≤ 10.0% after control of diet and exercises;
- Male and female,age between 18 and 70 years;
- BMI between 18.5-35kg/m2;
- Willing to be assigned to any treatment arm and sign inform consent.
- Type 1 diabetes;
- Treated by oral or injective antidiabetic drug before screening, including insulin and herb;
- Fasting plasma glucose > 13.3 mmol/L (240 mg/dL);
- Resistant hypertension [blood pressure above the goal despite adherence to at least 3 optimally dosed antihypertensive medications (including diuretic) of different classes,or blood pressure is controlled to below the goal by at least 4 different classes of drugs];
- Plasma triglyceride > 500 mg/dL (5.65 mmol/L);
- Is treating by fibrates;
- History of diabetic ketoacidosis,diabetic hyperglycemic hyperosmolar syndrome,lactic acidosis, diabetic hypoglycemia; or is currently combined with retinopathy, diabetic nephropathy and diabetic neuropathy;
- Had transient ischemic attack,cerebrovascular accident or unstable angina in the past 6 months;
- History of myocardial infarction or had conducted coronary angioplasty or coronary artery bypass graft surgery;
- Heart failure (NYHA classification Stage III or IV), or left ventricular hypertrophy indicated by ECG;
- Hepatic diseases such as hepatocirrhosis, active hepatitis,aspartate aminotransferase or alanine aminotransferase > 2.5 fold of the upper limit of the normal range;
- Kidney diseases or serum creatinine exceed the normal range: male > 133 μmol/L or female >108 μmol/L;
- Had malignancy in the past 5 years, not including basal cell carcinoma;
- Had or is currently receiving treatment that can alter blood glucose metabolism, including but not limited to diuretic,hormone (corticotropin or steroids),beta blockers;
- Have the diseases that can alter blood glucose metabolism, including but not limited to active hepatitis, hyperthyroidism,or adrenal tumors;
- Edema with unknown reason;
- Alcohol or drug addiction;
- Had participated other drugs' clinical trials in the 3 months before screening;
- Pregnant or lactic women; or women of childbearing age who are not able to or is not willing to conduct contraception;
- Any condition that make investigator consider the subject is not suitable to participate the trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Chiglitazar Patients administrate Chiglitazar 32mg once daily for 52 weeks Arm 2 Chiglitazar Patients administrate Chiglitazar 48mg once daily for 52 weeks Arm 3 Chiglitazar Patients administrate placebo for 24 weeks.From week 25 to 52, patients are randomly switched to Arm 1 and Arm 2, and receive the treatment accordingly. Arm 3 Placebo Patients administrate placebo for 24 weeks.From week 25 to 52, patients are randomly switched to Arm 1 and Arm 2, and receive the treatment accordingly.
- Primary Outcome Measures
Name Time Method Change in HbA1c from baseline after 24 weeks of treatment 24 weeks The change of HbA1c at week 24 from baseline
- Secondary Outcome Measures
Name Time Method Change in HbA1c from baseline for patients with a baseline HbA1c >=8.5% 24 weeks The change of HbA1c at week 24 from baseline for patients with a HbA1c \>=8.5% at baseline
Change in HbA1c from baseline in patients with a baseline HbA1c < 8.5% 24 weeks The change of HbA1c at week 24 from baseline for patients with a HbA1c \< 8.5% at baseline
Change in HbA1c from baseline 52 weeks The change of HbA1c at week 52 from baseline
Percentage of patients that attained target HbA1c <7.0% 24 weeks Percentage of patients whose HbA1c at week 24 are \< 7.0%
Percentage of patients whose HbA1c lowered by at least 0.5% 24 weeks Percentage of patients whose change of HbA1c at week 24 from baseline are \>= 0.5%
Change in fasting plasma glucose from baseline 12,24 and 52 weeks The change of fasting plasma glucose at week 12 and 24 from baseline
Change in 2-h postprandial glucose (2hPPG) from baseline 12, 24 and 52 weeks The change of 2-h postprandial glucose (2hPPG) at week 12, 24 and 52 from baseline
Change in total cholesterol (TC) from baseline 12, 24 and 52 weeks The change of total cholesterol (TC) at week 12, 24 and 52 from baseline
Change in triglyceride from baseline 12,24 and 52 weeks The change of triglyceride at week 12, 24 and 52 from baseline
Change in high density lipoprotein cholesterol (HDL-C)from baseline 12, 24 and 52 weeks The change of high density lipoprotein cholesterol (HDL-C) at week week 12, 24 and 52 from baseline
Change in low density proprotein cholesterol (LDL-C) from baseline 12, 24 and 52 weeks The change of low density lipoprotein cholesterol (LDL-C) at week 12, 24 and 52 from baseline
Change in free fatty acid (FFA) from baseline 12, 24 and 52 weeks The change of free fatty acid (FFA) at week 12, 24 and 52 from baseline
Change in fasting plasma insulin from baseline 12, 24 and 52 weeks The change of fasting plasma insulin at week 12, 24 and 52 from baseline
Insulin sensitivity assessed by the homeostatic model assessment (HOMA) at 12,24 and 52 weeks, compared with that of baseline 12, 24 and 52 weeks The change of insulin sensitivity at week 12, 24 and 52 from baseline
Change in blood pressure from baseline 24 weeks The change of blood pressure at week 24 from baseline
Percentage of patients who use rescue therapy 52 weeks The percentage of patients who use rescue therapy during the 52 weeks of treatment
Trial Locations
- Locations (26)
Peking University Shougang Hospital
🇨🇳Beijing, Beijing, China
China Meitan General Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Tangshan Gongren Hospital
🇨🇳Tangshan, Hebei, China
Cangzhou's Central Hospital
🇨🇳Cangzhou, Hebei, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Chenzhou First People's Hospital
🇨🇳Chenzhou, Hunan, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
Huaxi Hopsital of Sichuan University
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital of Ha'erbin Medical University
🇨🇳Ha'erbin, Heilongjiang, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The Affiliated Hospital of Qingdao Medical University
🇨🇳Qingdao, Shandong, China
The Affiliated Hospital of Xuzhou Medical College
🇨🇳Xuzhou, Jiangsu, China
The Central Hospital of Yangpu District of Shanghai
🇨🇳Shanghai, Shanghai, China
The Third Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The General Hospital of Tianjin Medical University
🇨🇳Tianjin, Tianjin, China
The people's Hospital of Jiangsu Province
🇨🇳Nanjing, Jiangsu, China
Baogang Hospital of Inner Mongilia
🇨🇳Baotou, Inner Mongolia, China
The First Affiliated Hospital of The 4th Military Medical University
🇨🇳Xi'an, Shanxi, China
Chongqing Three Gorges Central Hospital
🇨🇳Chongqing, Chongqing, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Harrison International Peace Hospital
🇨🇳Hengshui, Hebei, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
The 306th Hospital of PLA
🇨🇳Beijing, Beijing, China