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Colchicine for Primary Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes

RecruitingPhase 2Ages 21 Years - 80 YearsAllTan Tock Seng Hospital
NCT07837934 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study will test whether a low-cost anti-inflammatory medicine called colchicine can help protect the blood vessels of people with type 2 diabetes. Diabetes speeds up hardening of the arteries (atherosclerosis), partly because of ongoing low-grade inflammation. Colchicine has already been shown to help prevent heart attacks and strokes in people who already have heart disease; this study looks at whether it can also help prevent early blood vessel damage before heart disease develops. Around 300 adults with type 2 diabetes will be randomly assigned to take colchicine or a placebo (dummy pill) once daily for 24 weeks, in addition to their usual diabetes and heart-risk medications. Neither participants nor the study team will know who is taking colchicine or placebo. The main measurement will be the change in the thickness of the wall of the neck (carotid) artery, measured by ultrasoun

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📋 Eligibility rules (as published)
Inclusion Criteria: * T2DM on stable diabetes medications (no change in last 3 months) * At least one other comorbidity of hypertension, dyslipidaemia and/or obesity (BMI ≥27), with no previous history of ASCVD * Able to provide informed consent Exclusion Criteria: 1. Recent hospitalization or acute infections within last 2 weeks. 2. Current Treatment with corticosteroids or immunosuppressive agents 3. Pre-existing malignancies or other terminal conditions with limited prognosis 4. Pregnancy 5. Breastfeeding 6. Inability to provide written consent 7. Renal impairment (eGFR\< 60ml/min) 8. Liver cirrhosis or ALT/AST \>3x ULN 9. Pharmacogenomics indicative of adverse effects 10. Hypersensitivity to the active substance or to the following excipients: Lactose, Maize starch, Sodium laurilsulfate, Magnesium stearate 11. Known blood dyscrasia 12. Women of childbearing age who are keen to conceive in the next 1 year 13. Taking a strong P-glycoprotein inhibitor (e.g. cyclosporine, ranolazine) or a strong CYP3A4 inhibitor 14. Known myositis with raised creatine kinase with statins (statin myopathy). 15. Gout attack within the last 1 year 16. Currently taking Aspirin 17. Taking any oral contraceptives
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What it tests

  • Colchicine 0.5 MG Oral Tablet Once Daily
  • Placebo
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Where

1 site
Tan Tock Seng Hospital
Singapore, Singapore
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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