The effect of colchicine, on insulin sensitivity in individuals with type 1 diabetes and systemic low-grade inflammation (INS1GHT)
Key facts
- Where
- Hellerup, DániaSee the site
- Phase
- 2. fázis
Where in Dánia
- Gentofte HospitalHellerup, DániaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gentofte Hospital
- Trial code
- EU 2025-522528-29-00
- Record updated
- 2025. szeptember 26.
- Original description
This randomised, double-blind, placebo-controlled, crossover study will investigate the effect of four weeks of colchicine adjunctive to standard care (SoC) on insulin sensitivity in persons with T1D, systemic low-grade inflammation and reduced insulin sensitivity. Colchicine is taken as a tablet of 0.5 mg once daily (OD) for two weeks followed by 0.5 mg twice daily (BID) for two weeks. Systemic low-grade inflammation is assessed by a high-sensitivity CRP (hsCRP) assay ≥2 mg/dl and insulin sensitivity is assessed by an estimated glucose disposal rate (eGDR) <8 mg/kg/min OR insulin usage of ≥1 insulin units (IU)/kg pr day. The primary aim is to evaluate the effect of colchicine on insulin sensitivity expressed as the average glucose infusion rate (M-value [mg/kg/min]) during a hyperinsulinaemic-euglycaemic (HIE) clamp as compared to placebo treatment.Read full original descriptionShow less
This randomised, double-blind, placebo-controlled, crossover study will investigate the effect of four weeks of colchicine adjunctive to standard care (SoC) on insulin sensitivity in persons with T1D, systemic low-grade inflammation and reduced insulin sensitivity. Colchicine is taken as a tablet of 0.5 mg once daily (OD) for two weeks followed by 0.5 mg twice daily (BID) for two weeks. Systemic low-grade inflammation is assessed by a high-sensitivity CRP (hsCRP) assay ≥2 mg/dl and insulin sensitivity is assessed by an estimated glucose disposal rate (eGDR) <8 mg/kg/min OR insulin usage of ≥1 insulin units (IU)/kg pr day. The primary aim is to evaluate the effect of colchicine on insulin sensitivity expressed as the average glucose infusion rate (M-value [mg/kg/min]) during a hyperinsulinaemic-euglycaemic (HIE) clamp as compared to placebo treatment.
Inclusion: T1D for more than five years and c-peptid <200 pmol/L; Age 18–80 years; User of a CGM system; HbA1c 42-75 mmol/mol; Stable insulin therapy; eGFR ≥ 60 mL/min/L/1.73 m²; hsCRP ≥ 2 mg/L.
Exclusion: Treatment with anti-inflammatory drugs; Treatment with colchicine within 60 days of screening visit; Haemodialysis or peritoneal dialysis therapy; Treatment with a P-glycoprotein inhibitor or a strong CYP3A4 inhibitor; Other concomitant disease or treatment that according to the investigator's assessment makes the individual unsuitable for study participation; Alcohol/drug abuse; Receipt of any investigational drug within 30 days prior to visit 1; Immunosuppressive therapy or state of chronic immunodeficiency, including infection with human immunodeficiency virus (HIV); Known or suspected hypersensitivity to colchicine; History of cirrhosis, chronic active hepatitis, or severe hepatic disease; Inflammatory bowel disease or chronic diarrhoea; Treatment with glucose lowering drugs other than insulin; Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal; Pre-existing progressive neuromuscular disease or individuals with creatinine kinase levels > three times the upper limit of normal; Leukocyte cell count < 3.0 X 109/L; Thrombocyte count < 110 X 109/L; Cancer or lymphoproliferative disease unless in complete remission for > 5 years; Hypoglycaemia unawareness; Intake of grapefruit juice; Pregnant or nursing women; Simultaneous participation in any other clinical intervention trial; Women of child bearing potential not using contraceptive; Blood dyscrasias.