Repurposing colchicine for reduction of residual inflammatory risk in type 1 diabetes (REC1TE): a randomized, double-blind, placebo-controlled, investigator-initiated trial

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Type 1 diabetes for more than five years according to World Health Organization criteria, Age 18–80 years, HbA1c < 80 mmol/mol, Stable insulin therapy (defined as no change in insulin brand and not newly initiated continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI) therapy) and, if applicable, stable usage of glucose monitoring technology (e.g., continuous glucose monitoring CGM or intermittently scanned CGM) = 3 months with either MDI or CSII, C-reactive protein = 2 mg/l (measured by high-sensitivity assay), Estimated glomerular filtration rate > 50 ml/min/l/1.73 m^2, Either stable atherosclerotic cardiovascular (CV) disease (as defined by ischaemic heart disease including previous acute myocardial infarction, acute coronary syndrome and coronary revascularization; other arterial revascularization procedures; stroke and transient ischaemic attack; aortic aneurysm; peripheral arterial disease, including carotid atherosclerosis) or high risk thereof ((i.e., high or very high CV risk) as defined by the European Society of Cardiology (Eur Heart J 2020; 41: 255–323) 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, On permanent treatment with colchicine that is not discontinued within 30 days of visit 0, Known or suspected hypersensitivity to colchicine, Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within seven days , and the last measured value as being conclusive), Receipt of any investigational drug within 30 days prior to visit 0, Simultaneous participation in any other clinical intervention trial, 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 visit 0 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), Thrombocyte count < 110 X 10^9/L, Blood dyscrasias (e.g., myelodysplastic syndromes or related hematological disorders), Leukocyte cell count < 3.0 X 10^9/L, Intake of grape fruit juice during trial participation, 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, 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 chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives, Pregnant or nursing women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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