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NCT Number: NCT06959784

Assessing Incretin Therapy for Cardiovascular Risk Reduction and Diabetes Remission( ITCRDR Study)

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.

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Key information

Conditions

Diabetes Mellitus Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disease Cerebrovascular Disorders Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

China-Japan Friendship hospital

Beijing, 100029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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).

Treatment and study plan

semaglutide

Drug

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).

metformin

Drug

The metformin control group was treated with metformin (gradually increasing to 1g bid) for 24 weeks (6 months)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. The remission rate of diabetes

    Time frame: at 9 months, 1 year and 2 years of follow-up

  2. Glycated hemoglobin

    Time frame: Baseline and every 12 weeks until 96 weeks

    Reduced levels of glycated hemoglobin

  3. Fasting and postprandial blood glucose levels

    Time frame: at 2 year and 8 year of follow-up

  4. pancreatic islet function

    Time frame: Baseline, 48 weeks and 96 weeks

    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.

  5. Heart rate

    Time frame: Baseline, 48 weeks and 96 weeks

    The heart rate of the subjects were measured by electrocardiogram when they were at rest.

  6. Carotid artery peak systolic velocity

    Time frame: Baseline, 48 weeks and 96 weeks

    Evaluate the systolic peak blood flow velocity through carotid artery ultrasound.

  7. Routine urine examination

    Time frame: Baseline, 48 weeks and 96 weeks

    Evaluate the levels of red blood cells, white blood cells, urine glucose, urine ketones, and urine protein in urine through urine routine testing.

  8. Urine microalbumin

    Time frame: Baseline, 48 weeks and 96 weeks

    Urine microalbuminuria for early assessment of renal damage.

  9. Heart rhythm

    Time frame: Baseline, 48 weeks and 96 weeks

    The heart rhythm of the subjects were measured by electrocardiogram when they were at rest.

  10. Carotid artery peak diastolic velocity

    Time frame: Baseline, 48 weeks and 96 weeks

    Evaluate the diastolic peak blood flow velocity through carotid artery ultrasound.

  11. Carotid resistance index

    Time frame: Baseline, 48 weeks and 96 weeks

    Evaluate resistance index through carotid artery ultrasound. Carotid resistance index = (peak systolic velocity - end diastolic velocity) / peak systolic velocity

  12. common carotid artery diameter

    Time frame: Baseline, 48 weeks and 96 weeks

    Evaluate the common carotid artery diameter through carotid artery ultrasound.

  13. Carotid artery wall thickness

    Time frame: Baseline, 48 weeks and 96 weeks

    Evaluate the wall thickness through carotid artery ultrasound.

  14. Carotid Intima-media Thickness

    Time frame: Baseline, 48 weeks and 96 weeks

    Evaluate the intimal thickness through carotid artery ultrasound.

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

Evidence Based Evaluation of Incretin Drugs in Reducing the Risk of Cardiovascular and Cerebrovascular Events and Promoting the Remission of Diabetes

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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