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

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

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

Study 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 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.

Eligibility

Primary outcome measure(s)

• Cardiovascular and cerebrovascular event risk score — 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 — 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 — Baseline and every 12 weeks until 96 weeks
  Cerebrovascular diseases include ischemic stroke, hemorrhagic stroke, transient ischemic attack, cerebral vascular malformation, etc.

Trial sites (1)

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