- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02366377
The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Combination With Metformin in Type 2 Diabetes Mellitus Patients
February 18, 2015 updated by: Jiangsu HengRui Medicine Co., Ltd.
An Efficacy, Safety, and Tolerability Study of SHR3824 in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
The purpose of this study is to evaluate the efficacy and safety of 3 different doses of SHR3824 compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
168
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 been treated with metformin for more than 8 weeks with dose more than 1500mg/day.
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SHR3824 Placebo
SHR3824 Placebo , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
|
|
Experimental: SHR3824 5 mg
SHR3824 5 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
|
|
Experimental: SHR3824 10 mg
SHR3824 10 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
|
|
Experimental: SHR3824 20 mg
SHR3824 20mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adjusted Mean Change in HbA1c Levels
Time Frame: Baseline to Week 12
|
Baseline to Week 12
|
The number of volunteers with adverse events as a measure of safety and tolerability
Time Frame: Baseline to Week 12
|
Baseline to Week 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adjusted Mean Change in Fasting Plasma Glucose
Time Frame: Baseline to Week 12
|
Baseline to Week 12
|
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
Time Frame: Baseline to Week 12
|
Baseline to Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Anticipated)
March 1, 2016
Study Registration Dates
First Submitted
February 12, 2015
First Submitted That Met QC Criteria
February 18, 2015
First Posted (Estimate)
February 19, 2015
Study Record Updates
Last Update Posted (Estimate)
February 19, 2015
Last Update Submitted That Met QC Criteria
February 18, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR3824-108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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