Efficacy and Safety of SHR3824 as Monotherapy in Subjects With Type 2 Diabetes
- Registration Number
- NCT03159052
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 450
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SHR3824 10 mg SHR3824 once daily, 52 weeks SHR3824 Placebo Placebo once daily, 24 weeks SHR3824 5 mg SHR3824 once daily, 52 weeks
- Primary Outcome Measures
Name Time Method 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
Name Time Method Adjusted Mean Change in Fasting Plasma Glucose Baseline to Week 24
Trial Locations
- Locations (1)
Chinese PLA General Hospital
🇨🇳Beijing, China