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

NCT ID: NCT06959784

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Cerebrovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin control group

The metformin control group received metformin (gradually increased to 1 g bid) for 24 weeks (6 months)

Group Type: PLACEBO_COMPARATOR

Metformin

Intervention Type: DRUG

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

semaglutide group

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).

Group Type: EXPERIMENTAL

semaglutide

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

Metformin

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

Intervention Type: DRUG

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).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bo Zhang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

China-Japan Friendship hospital

Beijing, , China

Countries

China

Other Identifiers

2024-1-4064

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024-1-4064

Identifier Type: -

Identifier Source: org_study_id