Overview
Study of Chiglitazar Compare With Sitagliptin in Type 2 Diabetes Patients
Status:
Completed
Completed
Trial end date:
2017-01-01
2017-01-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with Sitagliptin.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Chipscreen Biosciences, Ltd.Treatments:
Sitagliptin Phosphate
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 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.