Assessing Incretin Therapy for Cardiovascular Risk Reduction and Diabetes Remission( ITCRDR Study)
- Status
- Enrolling by invitationResults none
- Why it is watched
- non-weight indication: cardiovascular, cerebrovascular
- Who it enrolls
- age 30 Years to 70 Years; no BMI minimum stated; conditions: Diabetes Mellitus; Cardiovascular Diseases; Cerebrovascular Disease
- Interventions
- semaglutide; Metformin
- Conditions
- Diabetes Mellitus; Cardiovascular Diseases; Cerebrovascular Disease
- Phase and size
- Phase 4 · 142 participants
- Dates
- Start 2024-01-01
Primary completion 2026-12-31 - Sponsor
- China-Japan Friendship Hospital (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Cardiovascular and cerebrovascular event risk scoreOne-year follow-up
- Major Adverse Cardiovascular EventsBaseline and every 12 weeks until 96 weeks
- Cerebrovascular disease eventsBaseline and every 12 weeks until 96 weeks
02Eligibility
Who can take part
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).
03Change log
Registry changes
No changes recorded since the trial was added.