Type 2 Diabetes MellitusPhase 3NCT04390295
Efficacy and Safety of SHR3824 in Combination With Metformin in Subjects With Type 2 Diabetes
A Phase 3 study testing SHR3824 and metformin in people with Type 2 Diabetes Mellitus, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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 Diabetes. 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
- 450 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2017to May 2020
- Phase
- Phase 3
- 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;
- 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;
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).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Third Affiliated Hospital of Sun Yat - sen University
Guangzhou, Guangdong
Weng Jianping, professor, 86-(20)85253239, wjianp@mail.sysu.edu.cn
Chen Jianwen, 18036611985, chenjianwen@hrglobe.cn
About this study
Official title: Clinical Trial to Evaluate the Efficacy and Safety of SHR3824 Combined With Metformin in Metformin Monotherapy Poorly Glycemic Controlled Chinese Type 2 Diabetic Patients
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 Diabetes. Efficacy and safety will be evaluated by comparing the effect of SHR3824 with metformin to placebo with metformin when given in oral doses.
Read the 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, placebo-parallel control). The 450 subjects received at least eight weeks of metformin monotherapy at a steady dose of 1500 mg or more before screening.
Evaluation of efficacy: compared with the group of placebo combined with metformin, HbA1c, fasting plasma glucose, postprandial plasma glucose, fasting body weight and blood pressure changes in the SHR3824 with metformin group
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Placebo, SHR3824, 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.
PlaceboDrug
Once daily, 24 weeks
SHR3824Drug
Once daily, 52 weeks
metforminDrug
Three times daily, 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| SHR3824+Metformin, Placebo+Metformin | Experimental | once daily for SHR3824 and placebo, three times daily for metformin, 24 weeks Receives: Drug: Placebo |
| SHR3824 5 mg+Metformin | Experimental | once daily for SHR3824, three times daily for metformin, 52 weeks Receives: Drug: SHR3824; Drug: metformin |
| SHR3824 10 mg+Metformin | Experimental | once daily for SHR3824, three times daily for metformin, 52 weeks 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
Compared with the placebo with metformin group, mean change in HbA1c Levels in SHR3824 with metformin group
Measured: Baseline to Week 24
Secondary outcomes (2)
Adjusted Mean Change in Fasting Plasma Glucose
Compared with the placebo with metformin group, mean change in Fasting Plasma Glucose Levels in SHR3824 with metformin group
Measured: Baseline to Week 24
The number of volunteers with adverse events as a measurement of safety
Compared with the placebo with metformin group, the incidence of adverse events in SHR3824 with metformin group
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start2 Nov 2017
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 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
- NCT04390295
- Sponsor's protocol ID
- SHR3824-302
- Status last verified
- May 2020
- First submitted
- 18 Sep 2018
- Last updated
- 15 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Efficacy and Safety of SHR3824 Combined With Metformin in Metformin Monotherapy Poorly Glycemic Controlled Chinese Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT04390295
- Acronym / sponsor ID
- SHR3824-302
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 15 May 2020 (actual)
- 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 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 Diabetes. Efficacy and safety will be evaluated by comparing the effect of SHR3824 with metformin to placebo with metformin when given in oral doses.
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, placebo-parallel control). The 450 subjects received at least eight weeks of metformin monotherapy at a steady dose of 1500 mg or more before screening.
Evaluation of efficacy: compared with the group of placebo combined with metformin, HbA1c, fasting plasma glucose, postprandial plasma glucose, fasting body weight and blood pressure changes in the SHR3824 with metformin group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SHR3824+Metformin, Placebo+Metformin | Experimental | Drug: Placeboonce daily for SHR3824 and placebo, three times daily for metformin, 24 weeks |
| SHR3824 5 mg+Metformin | Experimental | Drug: SHR3824, Drug: metforminonce daily for SHR3824, three times daily for metformin, 52 weeks |
| SHR3824 10 mg+Metformin | Experimental | Drug: SHR3824, Drug: metforminonce daily for SHR3824, three times daily for metformin, 52 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
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 |
|---|---|---|
| PlaceboOnce daily, 24 weeks | Drug | SHR3824+Metformin, Placebo+Metformin |
| SHR3824Once daily, 52 weeks | Drug | SHR3824 10 mg+Metformin, SHR3824 5 mg+Metformin |
| metforminThree times daily, 52 weeks | Drug | SHR3824 10 mg+Metformin, SHR3824 5 mg+Metformin |
Primary outcome
Adjusted Mean Change in HbA1c Levels
Time frame: Baseline to Week 24
Compared with the placebo with metformin group, mean change in HbA1c Levels in SHR3824 with metformin group
2 secondary outcomes
Adjusted Mean Change in Fasting Plasma Glucose
Time frame: Baseline to Week 24
The number of volunteers with adverse events as a measurement of safety
Time frame: Baseline to Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR3824 and metformin in people with Type 2 Diabetes Mellitus, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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 5 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 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact WENG Jianping, professor (86-020-85250217, wjianp@mail.sysu.edu.cn), or a site near the patient. 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 24). 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 15 May 2020.