RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Tan Tock Seng Hospital • ClinicalTrials.gov ID: NCT07837934

Registry updated: 2026-09-24

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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 ultrasound, which is an early sign of blood vessel disease. The study will also look at markers of inflammation in the blood, blood vessel stiffness and function, and changes in the gut bacteria.

Interventions

Colchicine 0.5 MG Oral Tablet Once Daily (Drug)
For 24 weeks
Placebo (Drug)
Matched placebo tablets (identical in size, shape, taste, and packaging to colchicine), once daily, for 24 weeks

Eligibility criteria

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

Conditions

Type 2 Diabetes Mellitus (T2DM) Atherosclerosis Cardiovascular Diseases

Locations

Tan Tock Seng Hospital — Singapore, Singapore, Singapore

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment