Status:
UNKNOWN
Efficacy and Safety of SHR3824 in Combination With Metformin in Subjects With Type 2 Diabetes
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to obtain information on efficacy and safety of SHR3824 with metformin over 24 weeks and 52 weeks in metformin monotherapy poorly glycemic controlled chinese Type 2 Diabet...
Detailed Description
A phase III clinical study on efficacy and safety of SHR3824 combined with metformin for type 2 diabetes with poor glucose control in metformin monotherapy (multicenter, randomized, double-blind, plac...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of type 2 diabetes mellitus;
- Patients with type 2 diabetes mellitus treated with metformin monotherapy for ≥ 8 weeks and poor glycemic control, metformin dose stabilized ≥1500mg / day;
- FPG\<=15mmol/L;
- Hemoglobin A1c levels \>=7.0% and \<=10.5%;
- Body mass index (BMI) 19 to 35 kg/m2;
Exclusion
- 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).
Key Trial Info
Start Date :
November 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04390295
Start Date
November 2 2017
End Date
May 1 2020
Last Update
May 15 2020
Active Locations (1)
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1
Third Affiliated Hospital of Sun Yat - sen University
Guangzhou, Guangdong, China