Repurposing Colchicine for Reduction of Residual Inflammatory Risk in Type 1 Diabetes (REC1TE)

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