Study of Chiglitazar Compare With Sitagliptin in Type 2 Diabetes Patients
NCT ID: NCT02173457
Last Updated: 2019-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
740 participants
INTERVENTIONAL
2014-09-30
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
Patients administrate Chiglitazar 32mg once daily for 24 weeks
Chiglitazar
Take orally
Arm 2
Patients administrate Chiglitazar 48mg once daily for 24 weeks
Chiglitazar
Take orally
Arm 3
Patients administrate Sitagliptin 100mg once daily for 24 weeks
Sitagliptin
Take orally
Interventions
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Chiglitazar
Take orally
Sitagliptin
Take orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. HbA1c≥ 7.5% and ≤ 10.0% after control of diet and exercises;
3. Male and female,age between 18 and 70 years;
4. BMI between 18.5-35kg/m2;
5. Willing to be assigned to any treatment arm and sign inform consent.
Exclusion Criteria
2. Treated by oral or injective antidiabetic drug before screening, including insulin and herb;
3. Fasting plasma glucose \> 13.3 mmol/L (240 mg/dL);
4. Resistant hypertension \[blood pressure above the goal despite adherence to at least 3 optimally dosed antihypertensive medications (including diuretic) of different classes,or blood pressure is controlled to below the goal by at least different classes of drugs\];
5. Plasma triglyceride \> 500 mg/dL (5.65 mmol/L);
6. Is treating by fibrates;
7. History of diabetic ketoacidosis,diabetic hyperglycemic hyperosmolar syndrome,lactic acidosis, diabetic hypoglycemia; or is currently combined with retinopathy, diabetic nephropathy and diabetic neuropathy;
8. Had transient ischemic attack,cerebrovascular accident or unstable angina in the past 6 months;
9. History of myocardial infarction or had conducted coronary angioplasty or coronary artery bypass graft surgery;
10. Had or is having pancreatic diseases;
11. Heart failure (NYHA classification Stage III or IV), or left ventricular hypertrophy indicated by ECG;
12. Hepatic diseases such as hepatocirrhosis, active hepatitis,aspartate aminotransferase or alanine aminotransferase \> 2.5 fold of the upper limit of the normal range;
13. Kidney diseases or serum creatinine exceed the normal range: male \> 133 μmol/L or female \>108 μmol/L;
14. Had malignancy in the past 5 years, not including basal cell carcinoma;
15. Had or is currently receiving treatment that can alter blood glucose metabolism, including but not limited to diuretic,hormone (corticotropin or steroids),beta blockers;
16. Have the diseases that can alter blood glucose metabolism, including but not limited to active hepatitis, hyperthyroidism,or adrenal tumors;
17. Edema with unknown reason;
18. Alcohol or drug addiction;
19. Had participated other drugs' clinical trials in the 3 months before screening;
20. Pregnant or lactic women; or women of childbearing age who are not able to or is not willing to conduct contraception;
21. Any condition that make investigator consider the subject is not suitable to participate the trial.
18 Years
70 Years
ALL
No
Sponsors
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Chipscreen Biosciences, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Weiping Jia, Dr.
Role: PRINCIPAL_INVESTIGATOR
Shanghai 6th People's Hospital
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
The First Hospital Affiliated to Anhui Medical University
Hefei, Anhui, China
Fuwai Hospital
Beijing, Beijing Municipality, China
The General Hospital of the Chinese People's Armed Police Forces
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
The Second Artillery General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Beijing Tongren Hospital Affiliated to Capital Medical Universtiy
Beijing, Beijing Municipality, 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
Tongji Hospital Affiliated to Tongji Medical College of HUST
Wuhan, Hubei, China
The First Hospital Affiliated to Nanhua University
Hengyang, Hunan, 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 Second Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Siping Central People's Hospital
Siping, Jilin, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shan'xi, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
The Qingpu Branch of Zhongshan Hospital Affiliate to Fudan University
Shanghai, Shanghai Municipality, China
Tongji Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai 5th People's Hospital
Shanghai, Shanghai Municipality, China
The Central Hospital of Minhang District of Shanghai
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Countries
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References
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Wang Y, Zhou Y, Zhou X, Su X, Xu X, Li H, Ma J. Effect of Chiglitazar and Sitagliptin on Bone Mineral Density and Body Composition in Untreated Patients with Type 2 Diabetes. Diabetes Metab Syndr Obes. 2023 Dec 27;16:4205-4214. doi: 10.2147/DMSO.S439479. eCollection 2023.
Zhou Y, Wang H, Wang Y, Xu X, Li F, Zhou J, Shan T, Huang R, Cai T, Liu X, Su X, Li H, Ma J. Comparative Evaluation of Chiglitazar and Sitagliptin on the Levels of Retinol-Binding Protein 4 and Its Correlation With Insulin Resistance in Patients With Type 2 Diabetes. Front Endocrinol (Lausanne). 2022 Apr 25;13:801271. doi: 10.3389/fendo.2022.801271. eCollection 2022.
Other Identifiers
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CGZ302
Identifier Type: -
Identifier Source: org_study_id
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