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Can a cheap Anti-Inflammatory pill shield diabetic arteries?

NCT ID NCT07837934

Prevention Sponsor: Tan Tock Seng Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time

Summary

Researchers are testing whether a low-cost anti-inflammatory drug called colchicine can slow early damage to the arteries in adults with type 2 diabetes. Diabetes speeds up hardening of the arteries partly through ongoing low-grade inflammation. About 300 adults with type 2 diabetes and no history of heart disease will take colchicine or a placebo pill once daily for 24 weeks alongside their usual medications. The main measure is the change in the thickness of the neck artery wall, an early sign of blood vessel disease, seen on ultrasound.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
colchicine, an anti-inflammatory medicine
What this could lead to
If it works, a cheap daily pill could become a new way to protect blood vessels in people with type 2 diabetes before heart disease takes hold.
What could go wrong
This is a mid-stage trial of 300 people over 24 weeks, so it can only show early signs of benefit, not fewer heart attacks. Colchicine can cause stomach upset and, rarely, muscle or blood problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

atherosclerosis cardiovascular disorder Inflammation type 2 diabetes mellitus atherosclerotic cardiovascular disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerosis Cardiovascular diseases Type 2 diabetes mellitus (T2DM)

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Tan Tock Seng Hospital

    RECRUITING

    Singapore, Singapore, 308433, Singapore

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