Efficacy and Safety of SHR3824 as Monotherapy in Subjects With Type 2 Diabetes

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Clinical Trial to Evaluate the Efficacy and Safety of SHR3824 as Monotherapy in in Chinese Type 2 Diabetic Patients With Inadequate Glycemic Control by Diet and Exercise

The purpose of this study is to obtain information on efficacy and safety of SHR3824 over 24 weeks and 52 weeks in Chinese patients with Type 2 Diabetes. This will be done by comparing the effect of SHR3824 to placebo when given in oral doses.

Inclusion Criteria:

• Patients must have a diagnosis of type 2 diabetes mellitus;
• Patient either has not been previously treated with antihyperglycemic medication or has not been treated with antihyperglycemic in the last 8 weeks;
• FPG<=15mmol/L;
• Hemoglobin A1c levels >=7.0% and <=10.5%;
• Body mass index (BMI) 19 to 35 kg/m2;

Exclusion Criteria:

• Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);
• Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
• Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;
• History of myocardial infarction, unstable angina, or cerebrovascular disorder within 6 months before the start of the run-in period;
• Past or current history of malignant tumor;
• Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
• Pregnant women, lactating mothers, or women of childbearing potential;
• Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).