Type 2 Diabetes MellitusPhase 1NCT02366377
The PK/PD, Efficacy, Safety and Tolerability Study of SHR3824 in Combination With Metformin in Type 2 Diabetes Mellitus Patients
A Phase 1 study testing SHR3824 and Metformin in people with Type 2 Diabetes Mellitus, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- SHR3824 and Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- SHR3824, Placebo, Metformin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR3824Drug
PlaceboDrug
MetforminDrug
| Study group | Role | What they receive |
|---|---|---|
| SHR3824 Placebo | Experimental | SHR3824 Placebo , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug. Receives: Drug: Placebo; Drug: Metformin |
| SHR3824 5 mg | Experimental | SHR3824 5 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug. Receives: Drug: SHR3824; Drug: Metformin |
| SHR3824 10 mg | Experimental | SHR3824 10 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug. Receives: Drug: SHR3824; Drug: Metformin |
| SHR3824 20 mg | Experimental | SHR3824 20mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug. Receives: Drug: SHR3824; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted Mean Change in HbA1c Levels
Measured: Baseline to Week 12
The number of volunteers with adverse events as a measure of safety and tolerability
Measured: Baseline to Week 12
Secondary outcomes (2)
Adjusted Mean Change in Fasting Plasma Glucose
Measured: Baseline to Week 12
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366377
- Sponsor's protocol ID
- SHR3824-108
- Status last verified
- Feb 2015
- First submitted
- 12 Feb 2015
- Last updated
- 19 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02366377
- Acronym / sponsor ID
- SHR3824-108
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Mar 2016 (estimated)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SHR3824 Placebo | Experimental | Drug: Placebo, Drug: MetforminSHR3824 Placebo , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug. |
| SHR3824 5 mg | Experimental | Drug: SHR3824, Drug: MetforminSHR3824 5 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug. |
| SHR3824 10 mg | Experimental | Drug: SHR3824, Drug: MetforminSHR3824 10 mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug. |
| SHR3824 20 mg | Experimental | Drug: SHR3824, Drug: MetforminSHR3824 20mg , once daily, 12 weeks, Metformin, Three times daily, 500mg, background drug. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR3824 | Drug | SHR3824 10 mg, SHR3824 20 mg, SHR3824 5 mg |
| Placebo | Drug | SHR3824 Placebo |
| Metformin | Drug | SHR3824 10 mg, SHR3824 20 mg, SHR3824 5 mg, SHR3824 Placebo |
Primary outcome
Adjusted Mean Change in HbA1c Levels
Time frame: Baseline to Week 12
The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: Baseline to Week 12
2 secondary outcomes
Adjusted Mean Change in Fasting Plasma Glucose
Time frame: Baseline to Week 12
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
Time frame: Baseline to Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR3824 and Metformin in people with Type 2 Diabetes Mellitus, run by Jiangsu HengRui Medicine Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjusted Mean Change in HbA1c Levels (time frame: Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2015.