Clinical trial NCT02173457 (phase 3, status: completed)
Conditions: type 2 diabetes
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: chiglitazar, sitagliptin
SMILES: N[C@@H](CC(=O)N1CCN2C(C1)=NN=C2C(F)(F)F)CC1=CC(F)=C(F)C=C1F
Eligibility 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.