Diabetes MellitusPhase 4NCT06959784
Assessing Incretin Therapy for Cardiovascular Risk Reduction and Diabetes Remission( ITCRDR Study)
A Phase 4 study testing semaglutide and Metformin in people with Diabetes Mellitus and Cardiovascular Diseases, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
This study used the diabetes prevention and follow-up research queue in Daqing and the public database of UKbiobank to evaluate the risk factors of cardiovascular and cerebrovascular events in diabetes patients, and built the first risk prediction model of cardiovascular and cerebrovascular events in diabetes patients… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Cardiovascular Diseases, Cerebrovascular Disease
- What is being tested?
- semaglutide and Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed diabetes, with no previous use of hypoglycemic medications or having discontinued such medications for more than 3 months.
- Blood glucose elevation detected within one year (fasting blood glucose exceeding 7 mmol/L, postprandial blood glucose or random blood glucose exceeding 11.1 mmol/L).
- Age between 30 and 70 years (inclusive of boundary values).
- Hemoglobin A1c between 7% and 10% (inclusive of boundary values).
- BMI between 24 and 32.5 kg/m² (inclusive of boundary values).
Who cannot join
- History of coronary heart disease or cerebral infarction.
- Severe liver or kidney disease: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN); glomerular filtration rate less than 30 ml/min/1.73 m².
- History of malignant tumors.
- Use of systemic glucocorticoids (excluding local applications or inhalants) for one week or more within the three months prior to screening.
- Positive urine pregnancy test in women of childbearing age.
- History of pancreatitis, or amylase and/or lipase > 3 times the ULN.
- Personal history or family history of medullary thyroid carcinoma (MTC) in first-degree relatives, or genetic predisposition to MTC (such as multiple endocrine neoplasia syndrome).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evidence Based Evaluation of Incretin Drugs in Reducing the Risk of Cardiovascular and Cerebrovascular Events and Promoting the Remission of Diabetes
This study used the diabetes prevention and follow-up research queue in Daqing and the public database of UKbiobank to evaluate the risk factors of cardiovascular and cerebrovascular events in diabetes patients, and built the first risk prediction model of cardiovascular and cerebrovascular events in diabetes patients based on the Chinese population follow-up queue and externally verified, so as to identify high-risk groups and guide the early prevention of cardiovascular and cerebrovascular diseases in diabetes patients. To evaluate the effect of incretin drugs on reducing the risk of cardiovascular and cerebrovascular events, and the impact on the remission rate of diabetes in people with initial diabetes, a randomized, multicenter, controlled clinical study was conducted. The long-term follow-up of 2 years was conducted to evaluate whether the cardiovascular and cerebrovascular risks of those who stopped drug treatment after remission of diabetes compared with those who continued drug treatment were reduced, as well as the long-term impact of incretin on cardiovascular and cerebrovascular risks and the role of long-term mitigation of diabetes.
- Being tested
- semaglutide, Metformin
- Medical subject headings
- Diabetes Mellitus, Cardiovascular Diseases, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideDrug
The semaglutide intervention group received semaglutide (0.25 mg qw initially, increased to 0.5 mg qw after four weeks) for 24 weeks (6 months).
MetforminDrug
The metformin control group was treated with metformin (gradually increasing to 1g bid) for 24 weeks (6 months)
| Study group | Role | What they receive |
|---|---|---|
| Metformin control group | Placebo comparator | The metformin control group received metformin (gradually increased to 1 g bid) for 24 weeks (6 months) Receives: Drug: Metformin |
| semaglutide group | Experimental | The Semaglutide intervention group received semaglutide (starting at 0.25mg qw and increasing to 0.5mg qw after four weeks) for 24 weeks (6 months). Receives: Drug: semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular and cerebrovascular event risk score
The cardiovascular and cerebrovascular event score (0-100%)is based on the cardiovascular and cerebrovascular event risk prediction model for diabetic patients established in Objective 1. In this prediction model, age, gender, smoking status, body mass index, waist circumference, glycated hemoglobin, blood sugar, blood pressure, and blood lipids correspond to certain scores. Higher scores indicate a higher risk of cardiovascular and cerebrovascular events and a worse outcome.
Measured: One-year follow-up
Major Adverse Cardiovascular Events
The Mace event includes cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.
Measured: Baseline and every 12 weeks until 96 weeks
Cerebrovascular disease events
Cerebrovascular diseases include ischemic stroke, hemorrhagic stroke, transient ischemic attack, cerebral vascular malformation, etc.
Measured: Baseline and every 12 weeks until 96 weeks
Secondary outcomes (14)
The remission rate of diabetes
Measured: at 9 months, 1 year and 2 years of follow-up
Glycated hemoglobin
Reduced levels of glycated hemoglobin
Measured: Baseline and every 12 weeks until 96 weeks
Fasting and postprandial blood glucose levels
Measured: at 2 year and 8 year of follow-up
pancreatic islet function
The study evaluated pancreatic islet cell function by testing fasting insulin, insulin one hour after a steamed bread meal, and insulin two hours after a steamed bread meal.
Measured: Baseline, 48 weeks and 96 weeks
Heart rate
The heart rate of the subjects were measured by electrocardiogram when they were at rest.
Measured: Baseline, 48 weeks and 96 weeks
Carotid artery peak systolic velocity
Evaluate the systolic peak blood flow velocity through carotid artery ultrasound.
Measured: Baseline, 48 weeks and 96 weeks
Routine urine examination
Evaluate the levels of red blood cells, white blood cells, urine glucose, urine ketones, and urine protein in urine through urine routine testing.
Measured: Baseline, 48 weeks and 96 weeks
Urine microalbumin
Urine microalbuminuria for early assessment of renal damage.
Measured: Baseline, 48 weeks and 96 weeks
Heart rhythm
The heart rhythm of the subjects were measured by electrocardiogram when they were at rest.
Measured: Baseline, 48 weeks and 96 weeks
Carotid artery peak diastolic velocity
Evaluate the diastolic peak blood flow velocity through carotid artery ultrasound.
Measured: Baseline, 48 weeks and 96 weeks
Carotid resistance index
Evaluate resistance index through carotid artery ultrasound. Carotid resistance index = (peak systolic velocity - end diastolic velocity) / peak systolic velocity
Measured: Baseline, 48 weeks and 96 weeks
common carotid artery diameter
Evaluate the common carotid artery diameter through carotid artery ultrasound.
Measured: Baseline, 48 weeks and 96 weeks
Carotid artery wall thickness
Evaluate the wall thickness through carotid artery ultrasound.
Measured: Baseline, 48 weeks and 96 weeks
Carotid Intima-media Thickness
Evaluate the intimal thickness through carotid artery ultrasound.
Measured: Baseline, 48 weeks and 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Zhang, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959784
- Sponsor's protocol ID
- 2024-1-4064
- Other IDs
- 2024-1-4064
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence Based Evaluation of Incretin Drugs in Reducing the Risk of Cardiovascular and Cerebrovascular Events and Promoting the Remission of Diabetes
- ClinicalTrials.gov ID
- NCT06959784
- Acronym / sponsor ID
- 2024-1-4064
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 May 2025 (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.
This study used the diabetes prevention and follow-up research queue in Daqing and the public database of UKbiobank to evaluate the risk factors of cardiovascular and cerebrovascular events in diabetes patients, and built the first risk prediction model of cardiovascular and cerebrovascular events in diabetes patients based on the Chinese population follow-up queue and externally verified, so as to identify high-risk groups and guide the early prevention of cardiovascular and cerebrovascular diseases in diabetes patients. To evaluate the effect of incretin drugs on reducing the risk of cardiovascular and cerebrovascular events, and the impact on the remission rate of diabetes in people with initial diabetes, a randomized, multicenter, controlled clinical study was conducted. The long-term follow-up of 2 years was conducted to evaluate whether the cardiovascular and cerebrovascular risks of those who stopped drug treatment after remission of diabetes compared with those who continued drug treatment were reduced, as well as the long-term impact of incretin on cardiovascular and cerebrovascular risks and the role of long-term mitigation of diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin control group | Placebo comparator | Drug: MetforminThe metformin control group received metformin (gradually increased to 1 g bid) for 24 weeks (6 months) |
| semaglutide group | Experimental | Drug: semaglutideThe Semaglutide intervention group received semaglutide (starting at 0.25mg qw and increasing to 0.5mg qw after four weeks) for 24 weeks (6 months). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed diabetes, with no previous use of hypoglycemic medications or having discontinued such medications for more than 3 months.
- Blood glucose elevation detected within one year (fasting blood glucose exceeding 7 mmol/L, postprandial blood glucose or random blood glucose exceeding 11.1 mmol/L).
- Age between 30 and 70 years (inclusive of boundary values).
- Hemoglobin A1c between 7% and 10% (inclusive of boundary values).
- BMI between 24 and 32.5 kg/m² (inclusive of boundary values).
Key exclusion criteria (7 listed)
- History of coronary heart disease or cerebral infarction.
- Severe liver or kidney disease: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN); glomerular filtration rate less than 30 ml/min/1.73 m².
- History of malignant tumors.
- Use of systemic glucocorticoids (excluding local applications or inhalants) for one week or more within the three months prior to screening.
- Positive urine pregnancy test in women of childbearing age.
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 |
|---|---|---|
| semaglutideThe semaglutide intervention group received semaglutide (0.25 mg qw initially, increased to 0.5 mg qw after four weeks) for 24 weeks (6 months). | Drug | semaglutide group |
| MetforminThe metformin control group was treated with metformin (gradually increasing to 1g bid) for 24 weeks (6 months) | Drug | Metformin control group |
Primary outcome
Cardiovascular and cerebrovascular event risk score
Time frame: One-year follow-up
The cardiovascular and cerebrovascular event score (0-100%)is based on the cardiovascular and cerebrovascular event risk prediction model for diabetic patients established in Objective 1. In this prediction model, age, gender, smoking status, body mass index, waist circumference, glycated hemoglobin, blood sugar, blood pressure, and blood lipids correspond to certain scores. Higher scores indicate a higher risk of cardiovascular and cerebrovascular events and a worse outcome.
Major Adverse Cardiovascular Events
Time frame: Baseline and every 12 weeks until 96 weeks
The Mace event includes cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.
Cerebrovascular disease events
Time frame: Baseline and every 12 weeks until 96 weeks
Cerebrovascular diseases include ischemic stroke, hemorrhagic stroke, transient ischemic attack, cerebral vascular malformation, etc.
14 secondary outcomes
The remission rate of diabetes
Time frame: at 9 months, 1 year and 2 years of follow-up
Glycated hemoglobin
Time frame: Baseline and every 12 weeks until 96 weeks
Fasting and postprandial blood glucose levels
Time frame: at 2 year and 8 year of follow-up
pancreatic islet function
Time frame: Baseline, 48 weeks and 96 weeks
Heart rate
Time frame: Baseline, 48 weeks and 96 weeks
Carotid artery peak systolic velocity
Time frame: Baseline, 48 weeks and 96 weeks
Routine urine examination
Time frame: Baseline, 48 weeks and 96 weeks
Urine microalbumin
Time frame: Baseline, 48 weeks and 96 weeks
Heart rhythm
Time frame: Baseline, 48 weeks and 96 weeks
Carotid artery peak diastolic velocity
Time frame: Baseline, 48 weeks and 96 weeks
Carotid resistance index
Time frame: Baseline, 48 weeks and 96 weeks
common carotid artery diameter
Time frame: Baseline, 48 weeks and 96 weeks
Carotid artery wall thickness
Time frame: Baseline, 48 weeks and 96 weeks
Carotid Intima-media Thickness
Time frame: Baseline, 48 weeks and 96 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing semaglutide and Metformin in people with Diabetes Mellitus and Cardiovascular Diseases, run by China-Japan Friendship Hospital 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 7 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: enrolling by invitation, as of the sponsor's last update on 7 May 2025. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Cardiovascular and cerebrovascular event risk score (time frame: One-year follow-up). The study lists 3 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 7 May 2025.