DBPR108 Tablets in Type 2 Diabetes Mellitus Patients

Exclusion Criteria

• •FPG \> 15 mmol/L;
• •Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg during screening period;
• •Those who are known to be positive for HIV and syphilis;
• •known active hepatitis B virus infection, hepatitis C virus infection;
• •For patients with obvious liver diseases and chronic liver diseases, AST or ALT in screening stage was twice the normal upper limit.
• •In patients with renal insufficiency, serum creatinine at screening stage was 1.5 times higher than the upper limit of normal value;
• •Leukocyte and hemoglobin \< lower limit of normal value, triglyceride \> 5.7 mmol/L in screening stage;
• •With diabetic acute complications (including diabetic ketoacidosis, hypertonic non-ketoacid diabetic coma, lactic acidosis and hypoglycemic coma), chronic complications (proliferative diabetic retinopathy, diabetic nephropathy);
• •Use of insulin, pioglitazone, DPP-4 inhibitor, GLP-1 receptor agonist or any combination of two or more oral hypoglycemic drugs within 8 weeks before screening time.
• •Those who need insulin therapy;
• •Using and Used of glucocorticoids within 2 weeks before screening time.
• •without a pacemaker, the 12-lead ECG showed II or III degree atrioventricular block, long QT syndrome or corrected QT interval （QTc）\>500ms or atrial fibrillation during 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;
• •Inflammatory bowel disease, colon ulcer, partial intestinal obstruction or chronic intestinal diseases associated with digestive and absorption diseases;
• •Active pancreatitis, cholecystitis, gallstones and other digestive diseases;
• •History of severe hypoglycemia;
• •History of allergies with similar drugs (DPP-4 inhibitors) or those who are judged by the investigator to be allergic to the test drug;
• •Pregnancy, lactating women;
• •Subjects who are participating in other clinical trials or who have participated in other drug trials within 3 months prior to screening;
• •Not suitable for this clinical trial judged by the investigator.