The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Type 2 Diabetes Mellitus Patients
- Registration Number
- NCT02366351
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
The purpose of this study is to obtain information on PK/PD, efficacy and safety of SHR3824 over 12 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
- 168
Inclusion Criteria
- Patients must have a diagnosis of type 2 diabetes mellitus;
- Hemoglobin A1c levels >=7.5% and <=10.5%;
- Body mass index (BMI) 25 to 45 kg/m2;
- Patient either has not been previously treated with antihyperglycemic medication or has not been treated with antihyperglycemic in the last 10 weeks.
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 Placebo Placebo once daily, 12 weeks SHR3824 5 mg SHR3824 once daily, 12 weeks SHR3824 10 mg SHR3824 once daily, 12 weeks SHR3824 20 mg SHR3824 once daily, 12 weeks
- Primary Outcome Measures
Name Time Method Adjusted Mean Change in HbA1c Levels Baseline to Week 12 The number of volunteers with adverse events as a measure of safety and tolerability Baseline to Week 12
- Secondary Outcome Measures
Name Time Method Adjusted Mean Change in Fasting Plasma Glucose Baseline to Week 12 Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7% Baseline to Week 12
Trial Locations
- Locations (1)
Chinese PLA General Hospital
🇨🇳Beijing, China