Repurposing Colchicine for Reduction of Residual Inflammatory Risk in Type 1 Diabetes

• Status: Recruiting
• Trial end date: 2026-06-15
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this clinical trial is to evaluate if colchicine in addition to standard of care improves markers of inflammation and cardiovascular disease in persons with type 1 diabetes. Participants will be assigned to either 0,5 mg colchicine daily or placebo in a 1:1 ratio for 26 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Filip Krag Knop
• Collaborators: Juvenile Diabetes Research Foundation; University of Copenhagen
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• Type 1 diabetes for more than five years according to World Health Organization criteria

• Age 35-80 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