Old gout drug could help hearts of people with type 1 diabetes
NCT ID NCT05949281
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 Hide 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
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Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, Capital Region, 2900, Denmark
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