Back to resultsEfficacy and Safety of SHR3824 as Monotherapy in Subjects With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SHR3824
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
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).
Sites / Locations
- Chinese PLA General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
SHR3824 Placebo
SHR3824 5 mg
SHR3824 10 mg
Arm Description
once daily, 24 weeks
once daily, 52 weeks
once daily, 52 weeks
Outcomes
Primary Outcome Measures
Adjusted Mean Change in HbA1c Levels
The number of volunteers with adverse events as a measure of safety
Secondary Outcome Measures
Adjusted Mean Change in Fasting Plasma Glucose
Full Information
NCT ID
NCT03159052
First Posted
May 17, 2017
Last Updated
May 17, 2017
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03159052
Brief Title
Efficacy and Safety of SHR3824 as Monotherapy in Subjects With Type 2 Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR3824 Placebo
Arm Type
Experimental
Arm Description
once daily, 24 weeks
Arm Title
SHR3824 5 mg
Arm Type
Experimental
Arm Description
once daily, 52 weeks
Arm Title
SHR3824 10 mg
Arm Type
Experimental
Arm Description
once daily, 52 weeks
Intervention Type
Drug
Intervention Name(s)
SHR3824
Intervention Description
Once daily, 52 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily, 24 weeks
Primary Outcome Measure Information:
Title
Adjusted Mean Change in HbA1c Levels
Time Frame
Baseline to Week 24
Title
The number of volunteers with adverse events as a measure of safety
Time Frame
Baseline to Week 52
Secondary Outcome Measure Information:
Title
Adjusted Mean Change in Fasting Plasma Glucose
Time Frame
Baseline to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juming Lu, PhD
Phone
010-66937166
Email
lujuming301@126.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of SHR3824 as Monotherapy in Subjects With Type 2 Diabetes
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