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

China-Japan Friendship Hospital

Status and phase

Invitation-only

Phase 4

Conditions

Cerebrovascular Disease

Diabetes Mellitus

Cardiovascular Diseases

Treatments

Drug: semaglutide

Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT06959784

2024-1-4064 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

142 estimated patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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).