COLCHICINE; OPIUM, STANDARDIZED POWDERED; TIEMONIUM METHYLSULPHATE for Type 1 diabetes

Inclusion criteria

• {"criterion_text":"- T1D for more than five years and c-peptid <200 pmol/L\n- Age 18–80 years\n- User of a CGM system\n- HbA1c 42-75 mmol/mol\n- Stable insulin therapy\n- eGFR ≥ 60 mL/min/L/1.73 m²\n- hsCRP ≥ 2 mg/L"}

Exclusion criteria

• {"criterion_text":"- Hypoglycaemia unawareness\n- Immunosuppressive therapy or state of chronic immunodeficiency, including infection with human immunodeficiency virus (HIV)\n- Treatment with anti-inflammatory drugs\n- Treatment with colchicine within 60 days of screening visit\n- Known or suspected hypersensitivity to colchicine\n- Treatment with glucose lowering drugs other than insulin\n- Haemodialysis or peritoneal dialysis therapy\n- Treatment with a P-glycoprotein inhibitor or a strong CYP3A4 inhibitor\n- Intake of grapefruit juice\n- Other concomitant disease or treatment that according to the investigator's assessment makes the individual unsuitable for study participation\n- Alcohol/drug abuse\n- Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal\n- Pregnant or nursing women\n- Receipt of any investigational drug within 30 days prior to visit 1\n- Simultaneous participation in any other clinical intervention trial\n- Women of child bearing potential not using contraceptive\n- History of cirrhosis, chronic active hepatitis, or severe hepatic disease\n- Inflammatory bowel disease or chronic diarrhoea\n- Pre-existing progressive neuromuscular disease or individuals with creatinine kinase levels > three times the upper limit of normal\n- Cancer or lymphoproliferative disease unless in complete remission for > 5 years\n- Blood dyscrasias\n- Leukocyte cell count < 3.0 X 109/L\n- Thrombocyte count < 110 X 109/L"}

Primary endpoints

• {"endpoint_text":"- Change in M-value after four weeks of placebo/colchicine","definition_or_measurement_approach":"M-value = average glucose infusion rate (mg/kg/min) measured during a hyperinsulinaemic-euglycaemic (HIE) clamp; measured after four weeks of treatment and compared versus placebo."}

Secondary endpoints

• {"endpoint_text":"- Mean difference in M-value (adjusted to body surface area (BSA)","definition_or_measurement_approach":"M-value measured during HIE clamp and adjusted to body surface area (BSA)."}
• {"endpoint_text":"- Mean difference in M-value (adjusted to fat free mass)","definition_or_measurement_approach":"M-value measured during HIE clamp and adjusted to fat free mass."}
• {"endpoint_text":"- Mean difference in Insulin Sensitivity Index (ISI)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Mean difference in average daily insulin dosage","definition_or_measurement_approach":""}
• {"endpoint_text":"- Fold difference in Insulin sensitivity by estimated glucose disposal rate (eGDR)","definition_or_measurement_approach":"Insulin sensitivity also assessed by estimated glucose disposal rate (eGDR); study defines reduced insulin sensitivity as eGDR < 8 mg/kg/min."}
• {"endpoint_text":"- Fold difference in in fasting serum/plasma concentrations of inflammation markers \thsCRP, IL-6, Tumour necrosis factor α","definition_or_measurement_approach":"Fasting serum/plasma concentrations of inflammation markers measured (hsCRP, IL-6, TNF-α)."}

Denmark

Earliest CTIS Part Ii Submission Date

19-09-2025

Latest Decision Or Authorization Date

26-09-2025

Processing Time Days

7

Number Of Sites

1

Number Of Participants

26

Primary sponsor

Full Name

Gentofte Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Region Hovedstaden","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}