Clinical Trial of Trelagliptin Succinate Tablets in the Treatment of Type 2 Diabetes

Exclusion Criteria

• •Fasting plasma glucose≥13.9mmol/L or a history of severe hypoglycemia (blood sugar below 2.8mmol/L);
• •Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg during screening;
• •Positive for Acquired Immure Deficiency Syndrome（AIDS）or syphilis testing;
• •Active hepatitis B virus infection or hepatitis C virus infection;
• •History of acute or chronic liver disease, and Aspartate aminotransferase(AST) or Alanine minotransferase(ALT)\> 2.5 times of reference range or total bilirubin\> 1.5 times of reference range during the screening period;
• •Renal insufficiency subjects, the serum creatinine above 1.5 times of reference range during the screening period;
• •The white blood cells are outside of the reference range, hemoglobin below the reference range, triglyceride\>5.7mmol/L during the screening period;
• •Acute complications of diabetes (including diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis and hypoglycemia coma) ,or severe chronic complications (proliferative diabetic retinopathy, diabetic nephropathy);
• •Oral or intravenous use of glucocorticoids or regular application (ie continuous use more than one week within 4 weeks before screening time) with large doses of thiazide diuretics (hydrochlorothiazide, chlorothiazide, etc.);
• •Subjects without a pacemaker, the 12-lead ECG showed II or III degree atrioventricular block, long QT syndrome or corrected QT interval （QTc）\>450ms or atrial fibrillation during the screening period;
• •Active heart disease (including acute myocardial infarction, unstable angina) , moderate to severe congestive heart failure (NYHA class III or IV), or planned for coronary artery bypass grafting or transmyocardial laser revascularization half year before the screening period.
• •History of epilepsy, mental illness, major depression,or previous thyroid function abnormal and still being treated, or those with organ transplants, severe chronic lung disease, and other serious heart disease, cerebrovascular disease, blood disease;
• •Endocrine diseases such as hypercortisolism or polycystic ovary syndrome that may affect blood glucose levels;
• •Inflammatory bowel disease, colon ulcer, partial intestinal obstruction or obvious digestive and dysfunction chronic bowel disease;
• •Active pancreatitis, cholecystitis, gallstones and other digestive diseases;
• •Using weight loss surgery within 3 months before screening period or using weight-loss drugs (including traditional Chinese medicine diet pills) within2 months before screening period;
• •History of drug or drug abuse or alcoholics;
• •Blood donation within 2 months before screening includes blood components or massive blood loss (≥400mL),or receiving blood transfusion or using blood products;
• •History of allergies with similar drugs (DPP-4 inhibitors) or those who are judged by the investigator to be allergic to the test drug;
• •Subjects who are participating in other clinical trials or who have participated in other drug trials within 3 months prior to screening;
• •Pregnancy (defined as positive in pregnancy test), lactating women;
• •Not suitable for this clinical trial judged by the investigator.