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

NCT06959784 | Enrolling By Invitation Phase 4 DMC

• 1 other identifier: 2024-1-4064
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Cardiovascular and cerebrovascular event risk score

  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.

  One-year follow-up

• Major Adverse Cardiovascular Events

  The Mace event includes cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.

  Baseline and every 12 weeks until 96 weeks

• Cerebrovascular disease events

  Cerebrovascular diseases include ischemic stroke, hemorrhagic stroke, transient ischemic attack, cerebral vascular malformation, etc.

  Baseline and every 12 weeks until 96 weeks

Secondary Outcomes (14)

• The remission rate of diabetes

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

• Glycated hemoglobin

  Baseline and every 12 weeks until 96 weeks

• Fasting and postprandial blood glucose levels

  at 2 year and 8 year of follow-up

• pancreatic islet function

  Baseline, 48 weeks and 96 weeks

• Heart rate

  Baseline, 48 weeks and 96 weeks

Study Arms (2)

Metformin control group

PLACEBO COMPARATOR

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

Drug: Metformin

semaglutide group

EXPERIMENTAL

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).

Drug: semaglutide

Interventions

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).

semaglutide group

Metformin DRUG

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

Metformin control group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship hospital

Beijing, 100029, China

Location

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Cerebrovascular Disorders

Interventions

semaglutide; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 7, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-04

Locations

CN (1)