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Old gout drug could help hearts of people with type 1 diabetes

NCT ID NCT05949281

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This phase 2 trial tests whether a daily low dose of colchicine, an anti-inflammatory drug used for gout, can reduce inflammation and heart disease risk in adults with type 1 diabetes. 102 participants aged 35–80 will take either colchicine or a placebo for 26 weeks, with an optional 26-week extension and 5-year follow-up. The main goal is to see if colchicine lowers a key blood marker of inflammation (hsCRP).

What this could mean

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

Active substance
colchicine (0.5 mg oral tablet daily)
What this could lead to
If it works, this could point toward a way to lower heart disease risk in people with type 1 diabetes by reducing chronic inflammation.
What could go wrong
This is a small, early-phase trial testing only a marker of inflammation, not actual heart attacks or strokes. The drug may not show meaningful benefit or could cause side effects like stomach upset.

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

102 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Jan 2031

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

18 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: * Type 1 diabetes for more than five years according to World Health Organization criteria * Age 18-80 years * Hemoglobin A1c \< 80 mmol/mol * Stable insulin therapy (defined as no change in insulin brand and no newly initiated continous subcutaneus insulin infusion (CSII) or multiple-daily injection (MDI) therapy) and, if applicable, stable usage of glucose monitoring technology (e.g., continous glucose monitor (CGM) or intermittently scanned CGM) ≥ 3 months with either MDI or CSII * CRP ≥ 2 mg/L (measured by high-sensitivity assay) * eGFR \> 50 mL/min/L/1.73 m\^2 * Either stable arteriosclerotic cardiovascular disease (ASCVD) (as defined by ischemic heart disease including previous acute myocardial infarction, acute coronary syndrome and coronary revascularization; other arterial revascularization procedures; stroke and transient ischemic attack; aortic aneurysm; peripheral arterial disease, including carotid atherosclerosis) * and/or risk of cardiovascular (CV) death \> 5 % within 10 years (i.e., high or very high CV risk) as defined by the European Society of Cardiology or 10-year CV risk ≥ 20 % (i.e., high CV risk) as according to 'Steno Type 1 Diabetes Risk Engine' (https://steno.shinyapps.io/T1RiskEngine/) Exclusion Criteria: * Hypoglycemia unawareness (inability to register low blood glucose) am modum Pedersen-Bjergaard, unless usage of CGM with alarm function * Liver disease with elevated plasma alanine aminotransferase (ALT) \> three times the upper limit of normal (measured at screening with the possibility of one repeat analysis within seven days, and the last measured value as being conclusive) * History of cirrhosis, chronic active hepatitis or severe hepatic disease * Inflammatory bowel disease or chronic diarrhea * Pre-existing progressive neuromuscular disease or persons with creatinine kinase levels \> three times the upper limit of normal (measured at screening with the possibility of one repeat analysis within a week, and the last measured value as being conclusive) * Cancer or lymphoproliferative disease unless in complete remission for \> 5 years * Immunosuppressive therapy or state of chronic immunodeficiency, including infection with human immunodeficiency virus (HIV) * Blood dyscrasias (e.g., myelodysplastic syndromes or related hematological disorders) * Leukocyte cell count \< 3.0 X 10\^9/L * Thrombocyte count \< 110 X 10\^9/L * Systemic (oral or intravenous), long-term steroid therapy (topical or inhaled steroids are allowed) * Hemodialysis or peritoneal dialysis therapy (since colchicine cannot be removed by dialysis or exchange transfusion) * Renal or hepatic impairment treated with a P-gp inhibitor or a strong CYP3A4 inhibitor * Intake of grapefruit juice during trial participation * Other concomitant disease or treatment that according to the investigator's assessment makes the person unsuitable for study participation * Alcohol/drug abuse * Fertile women not using hormonal (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormone intrauterine devices (IUD), hormonal vaginal ring or transdermal hormonal patch), chemical (copper IUD) or mechanical (condom, femidom, sterilization) contraceptives * Pregnant or nursing women * On permanent treatment with colchicine that is not discontinued within 30 days of screening visit * Known or suspected hypersensitivity to colchicine * Receipt of any investigational drug within 30 days prior to screening visit * Simultaneous participation in any other clinical intervention trial

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Center for Clinical Metabolic Research, Gentofte Hospital

    Hellerup, Capital Region, 2900, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.