The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Combination With Metformin in Type 2 Diabetes Mellitus Patients
NCT ID: NCT02366377
Last Updated: 2015-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
168 participants
INTERVENTIONAL
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SHR3824 Placebo
SHR3824 Placebo , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
Placebo
Metformin
SHR3824 5 mg
SHR3824 5 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
SHR3824
Metformin
SHR3824 10 mg
SHR3824 10 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
SHR3824
Metformin
SHR3824 20 mg
SHR3824 20mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
SHR3824
Metformin
Interventions
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SHR3824
Placebo
Metformin
Eligibility Criteria
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Inclusion Criteria
* Hemoglobin A1c levels \>=7.5% and \<=10.5%;
* Body mass index (BMI) 25 to 45 kg/m2;
* Patient either has been treated with metformin for more than 8 weeks with dose more than 1500mg/day.
Exclusion Criteria
* 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).
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Other Identifiers
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SHR3824-108
Identifier Type: -
Identifier Source: org_study_id
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