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The effect of colchicine, on insulin sensitivity in individuals with type 1 diabetes and systemic low-grade inflammation (INS1GHT)
EU CTIS ID: 2025-522528-29-00
What this study is testing
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.
- 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
- 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
You likely can't join if
- Hypoglycaemia unawareness
- Immunosuppressive therapy or state of chronic immunodeficiency, including infection with human immunodeficiency virus (HIV)
- Treatment with anti-inflammatory drugs
- Treatment with colchicine within 60 days of screening visit
- Known or suspected hypersensitivity to colchicine
- Treatment with glucose lowering drugs other than insulin
See the full eligibility criteria
- 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
- Hypoglycaemia unawareness
- Immunosuppressive therapy or state of chronic immunodeficiency, including infection with human immunodeficiency virus (HIV)
- Treatment with anti-inflammatory drugs
- Treatment with colchicine within 60 days of screening visit
- Known or suspected hypersensitivity to colchicine
- Treatment with glucose lowering drugs other than insulin
- Haemodialysis or peritoneal dialysis therapy
- Treatment with a P-glycoprotein inhibitor or a strong CYP3A4 inhibitor
- Intake of grapefruit juice
- Other concomitant disease or treatment that according to the investigator's assessment makes the individual unsuitable for study participation
- Alcohol/drug abuse
- Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal
- Pregnant or nursing women
- Receipt of any investigational drug within 30 days prior to visit 1
- Simultaneous participation in any other clinical intervention trial
- Women of child bearing potential not using contraceptive
- History of cirrhosis, chronic active hepatitis, or severe hepatic disease
- Inflammatory bowel disease or chronic diarrhoea
- Pre-existing progressive neuromuscular disease or individuals with creatinine kinase levels > three times the upper limit of normal
- Cancer or lymphoproliferative disease unless in complete remission for > 5 years
- Blood dyscrasias
- Leukocyte cell count < 3.0 X 109/L
- Thrombocyte count < 110 X 109/L
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, 18-64 years, 65+ 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.