NCT07837934RecruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 6 Sept 2026
- Start date
- 24 Jul 2025
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Tan Tock Seng Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT07837934
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 300
- From 24 Jul 2025 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current Treatment with corticosteroids or immunosuppressive agents
- Taking a strong P-glycoprotein inhibitor (e.g. cyclosporine, ranolazine) or a strong CYP3A4 inhibitor
- Currently taking Aspirin
Other illness
- Recent hospitalization or acute infections within last 2 weeks.
- Pre-existing malignancies or other terminal conditions with limited prognosis
Lab values
- Renal impairment (eGFR\< 60ml/min)
- Liver cirrhosis or ALT/AST \>3x ULN
- Hypersensitivity to the active substance or to the following excipients: Lactose, Maize starch, Sodium laurilsulfate, Magnesium stearate
Age
- Women of childbearing age who are keen to conceive in the next 1 year
Other
- Pregnancy
- Breastfeeding
- Inability to provide written consent
- Pharmacogenomics indicative of adverse effects
- Known blood dyscrasia
- Known myositis with raised creatine kinase with statins (statin myopathy).
- Gout attack within the last 1 year
- Taking any oral contraceptives
Who the study is looking for
- 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
Age in the registry: 21 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tan Tock Seng Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.