Colchicine for preventing cardiovascular disease in adults with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, randomized, double-blind trial assigns about 300 adults with type 2 diabetes and no prior ASCVD to receive colchicine 0.5 mg daily or a matched placebo for 24 weeks, in addition to their standard care. Participants are stratified by a neutrophil inflammatory phenotype using a microfluidic organ-on-chip method to identify those at higher inflammatory risk. The primary outcome is change in carotid intima-media thickness, an early sign of subclinical atherosclerosis, measured by ultrasound. Secondary analyses will examine inflammatory markers and other vascular parameters to understand potential mechanisms. The study aims to determine whether targeting inflammation with colchicine can slow vascular changes in a high-risk diabetic population.

Why it matters

Who can join: the full rules

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

Where it's running

• Tan Tock Seng Hospital
  Singapore, Singapore, Singapore Recruiting

Study contacts

• Principal investigator: Rinkoo Dalan, MD, PhD — Tan Tock Seng Hospital
• Study coordinator: Sanchalika Acharyya, PhD, MPH
• Email: sanchalika.acharyya@nhghealth.com.sg
• Phone: 96150202

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.