Colchicine for Primary Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes
The Role of Colchicine in Preventing Atherosclerotic Cardiovascular Disease in Type 2 Diabetes (Col-DM Study)
- Type 2 Diabetes Mellitus (T2DM)
- Atherosclerosis
- Cardiovascular Diseases
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Tan Tock Seng Hospital
- Enrolment target
- 300
- Started
- 24 July 2025
- Main results due
- 31 July 2027
- Study sites
- 1
- Registry updated
- 24 September 2026
Can you take part?
- Ages 21 years to 80 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Tan Tock Seng Hospital
Singapore, Singapore, Singapore
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07837934. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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