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Repurposing colchicine for reduction of residual inflammatory risk in type 1 diabetes (REC1TE): a randomized, double-blind, placebo-controlled, investigator-initiated trial
EU CTIS ID: 2022-502038-23-00
What this study is testing
The primary aim is to determine the effect of colchicine on levels of high-sensitivity C-reactive protein (mg/l) as compared with placebo following 26 weeks of treatment
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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/)
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.