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Enrolling by invitation NCT06959784

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

Phase IV Interventional Diabetes Mellitus Cardiovascular Diseases Cerebrovascular Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: semaglutide, Metformin.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Cardiovascular Diseases, Cerebrovascular Disease. Basic parameters: 30 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Cardiovascular and cerebrovascular event risk score [Time frame: One-year follow-up]
  • Major Adverse Cardiovascular Events [Time frame: Baseline and every 12 weeks until 96 weeks]
  • Cerebrovascular disease events [Time frame: Baseline and every 12 weeks until 96 weeks]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • China-Japan Friendship hospital — Beijing

Identifiers

NCT: NCT06959784 · 2024-1-4064 · 2024-1-4064

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗