Efficacy and Safety of SP2086 as Monotherapy in Patients With Type 2 Diabetes

Exclusion Criteria

• •Patient has history of type 1 diabetes mellitus
• •Patient has history of ketoacidosis
• •Patient has history of severe unconscious hypoglycemosis
• •Patient has history of acute and chronic pancreatitis or pancreatic injury that may lead to high risk of pancreatitis
• •Patient has history of decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistence and clinical
• •Patient has history of a history of hypertension, and after antihypertensive treatment, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg
• •Patient has severe liver or kidney disease,alanine aminotransferase \>2×UNL, Aspartate Aminotransferase \>2×upper normal limit(UNL)；total bilirubin \>2×UNL； creatinine\>1.5 mg/dL (Male,132.6μmol/L) ，\>1.4 mg/dL(Female，123.8μmol/L)
• •Patient has severe chronic gastrointestinal disease or therapy that may affect drug absorption, such as gastrointestinal surgery
• •Patient has severe haematological diseases or other diseases leading to hemolyze and red blood cell unstable (malaria、haemolytic anaemia eg. )
• •Patient has other endocrine diseases, for example hyperthyroidism、hypothyroidism、hypercortisolism、multiple endocrine neoplasia and so on
• •Patient has history of malignancy
• •Patient has history of alcohol or drug abuse