Study of Chiglitazar Compare With Sitagliptin in Type 2 Diabetes Patients
- Registration Number
- NCT02173457
- Lead Sponsor
- Chipscreen Biosciences, Ltd.
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with Sitagliptin.
- Detailed Description
The efficacy and safety will be compared between Chiglitazar and Sitagliptin after treatment of 24 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 740
- 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 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;
- Had or is having pancreatic diseases;
- 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 2 Chiglitazar Patients administrate Chiglitazar 48mg once daily for 24 weeks Arm 1 Chiglitazar Patients administrate Chiglitazar 32mg once daily for 24 weeks Arm 3 Sitagliptin Patients administrate Sitagliptin 100mg once daily for 24 weeks
- 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 Percentage of patients that attained target HbA1c <7.0% 24 weeks Percentage of patients whose HbA1c at week 24 are \< 7.0%
Change in free fatty acid (FFA) from baseline 12 and 24 weeks The change of free fatty acid (FFA) at week 12 and 24 from baseline
Change in fasting plasma insulin from baseline 12 and 24 weeks The change of fasting plasma insulin at week 12 and 24 from baseline
Percentage of patients who discontinue the trial due to hyperglycemia 24 weeks The percentage of patients who discontinue the trial due to hyperglycemia during the 24 weeks of treatment
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 12 weeks The change of HbA1c at week 12 from baseline
Percentage of patients whose HbA1c lowered by at least 0.5% 24 weeks Percentage of patients whose change of HbA1c at week 24d from baseline are \>= 0.5%
Change in 2-h postprandial glucose (2hPPG) from baseline 12 and 24 weeks The change of 2-h postprandial glucose (2hPPG) at week 12 and 24 from baseline
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 fasting plasma glucose from baseline 12 and 24 weeks The change of fasting plasma glucose at week 12 and 24 from baseline
Change in high density lipoprotein cholesterol (HDL-C) from baseline 12 and 24 weeks The change of high density lipoprotein cholesterol (HDL-C) at week 12 and 24 from baseline
Change in low density proprotein cholesterol (LDL-C) from baseline 12 and 24 weeks The change of low density lipoprotein cholesterol (LDL-C) at week 12 and 24 from baseline
Change in total cholesterol (TC) from baseline 12 and 24 weeks The change of total cholesterol (TC) at week 12 and 24 from baseline
Change in triglyceride from baseline 12 and 24 weeks The change of triglyceride at week 12 and 24 from baseline
Insulin sensitivity assessed by the homeostatic model assessment (HOMA) at 12 and 24 weeks, compared with that of baseline 12 and 24 weeks The change of insulin sensitivity at week 12 and 24 from baseline
Change in blood pressure from baseline 24 weeks The change of blood pressure at week 24 from baseline
Trial Locations
- Locations (37)
The Second Artillery General Hospital of Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
The First People's Hospital of Yueyang
🇨🇳Yueyang, Hunan, China
The Affiliated Hospital of Inner Mongolia
🇨🇳Hohhot, Inner Mongolia, China
Huai'an First People's Hospital
🇨🇳Huai'an, Jiangsu, China
Gulou Hospital Affiliated to Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Siping Central People's Hospital
🇨🇳Siping, Jilin, China
Shanghai First People's Hospital
🇨🇳Shanghai, Shanghai, China
The Central Hospital of Minhang District of Shanghai
🇨🇳Shanghai, Shanghai, China
Shanghai 6th People's Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai 5th People's Hospital
🇨🇳Shanghai, Shanghai, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
The First Hospital Affiliated to Anhui Medical University
🇨🇳Hefei, Anhui, China
Fuwai Hospital
🇨🇳Beijing, Beijing, China
The General Hospital of the Chinese People's Armed Police Forces
🇨🇳Beijing, Beijing, China
Beijing Tiantan Hospital
🇨🇳Beijing, Beijing, China
Beijing Tongren Hospital Affiliated to Capital Medical Universtiy
🇨🇳Beijing, Beijing, China
The Third Hospital Affiliated to Guangzhou Medical College
🇨🇳Guangzhou, Guangdong, China
The Second Affiliated Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
Shenzhen Second People's Hospital
🇨🇳Shenzhen, Guangdong, China
Beijing University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Zhongshan People's Hospital
🇨🇳Zhongshan, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University (The Eastern Hospital)
🇨🇳Nanning, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University (The Western Hospital)
🇨🇳Nanning, Guangxi, China
The Second Hospital of Heibei Medical University
🇨🇳Shijiazhuang, Hebei, China
The First Hospital Affiliated to Nanhua University
🇨🇳Hengyang, Hunan, China
Tongji Hospital Affiliated to Tongji Medical College of HUST
🇨🇳Wuhan, Hubei, China
The Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
The Second Hospital Affiliated to Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
The Qingpu Branch of Zhongshan Hospital Affiliate to Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai Changzheng Hospital
🇨🇳Shanghai, Shanghai, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Tongji Hospital Affiliated to Tongji University
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China