Study of Chiglitazar Compare With Placebo in Type 2 Diabetes Patients

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chipscreen Biosciences, Ltd.

Criteria

Inclusion Criteria:

1. Meet the WHO Diagnostic Criteria for Type 2 Diabetes (published on 1999);

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:

1. Type 1 diabetes;

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 4 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. Heart failure (NYHA classification Stage III or IV), or left ventricular hypertrophy indicated by ECG;

11. Hepatic diseases such as hepatocirrhosis, active hepatitis,aspartate aminotransferase or alanine aminotransferase > 2.5 fold of the upper limit of the normal range;

12. Kidney diseases or serum creatinine exceed the normal range: male > 133 μmol/L or female >108 μmol/L;

13. Had malignancy in the past 5 years, not including basal cell carcinoma;

14. Had or is currently receiving treatment that can alter blood glucose metabolism, including but not limited to diuretic,hormone (corticotropin or steroids),beta blockers;

15. Have the diseases that can alter blood glucose metabolism, including but not limited to active hepatitis, hyperthyroidism,or adrenal tumors;

16. Edema with unknown reason;

17. Alcohol or drug addiction;

18. Had participated other drugs' clinical trials in the 3 months before screening;

19. Pregnant or lactic women; or women of childbearing age who are not able to or is not willing to conduct contraception;

20. Any condition that make investigator consider the subject is not suitable to participate the trial.