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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: SHR3824
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR3824 Placebo<br>once daily, 24 weeks | Drug: Placebo<br>* Once daily, 24 weeks<br>|
| Experimental: SHR3824 5 mg<br>once daily, 52 weeks | Drug: SHR3824<br>* Once daily, 52 weeks<br>|
| Experimental: SHR3824 10 mg<br>once daily, 52 weeks | Drug: SHR3824<br>* Once daily, 52 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean Change in HbA1c Levels |  | Baseline to Week 24 | 
| The number of volunteers with adverse events as a measure of safety |  | Baseline to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Mean Change in Fasting Plasma Glucose |  | Baseline to Week 24 |