Tests colchicine for insulin sensitivity in type 1 diabetes with inflammation
Tests colchicine against placebo in adults with type 1 diabetes and inflammation.
Key facts
- Who runs it
- Gentofte Hospital
- Where
- Hellerup, DenmarkSee the site
- Trial code
- Registry title
- The effect of colchicine, on insulin sensitivity in individuals with type 1 diabetes and systemic low-grade inflammation (INS1GHT)
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 26 people, planned
- Started
- 22 Dec 2025
- Expected to end
- 3 Nov 2027
- Type of study
- Interventional
- Record updated
- 26 September 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 1 diabetes for more than five years, with signs of low-grade inflammation, to test whether colchicine improves insulin sensitivity.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Type 1 diabetes for more than five years, with c-peptid <200 pmol/L and hsCRP ≥ 2 mg/L. HbA1c 42-75 mmol/mol (6–9%). eGFR ≥ 60 mL/min/L/1.73 m².
- Earlier treatment
- Must use a CGM system and be on stable insulin therapy. Must not have taken colchicine within 60 days of screening.
- Biomarker or test result
- hsCRP ≥ 2 mg/L, c-peptid <200 pmol/L, HbA1c 42-75 mmol/mol (6–9%), eGFR ≥ 60 mL/min/L/1.73 m².
Main reasons for not taking part
- Hypoglycaemia unawareness
- Immunosuppressive therapy or chronic immunodeficiency, including HIV
- Treatment with anti-inflammatory drugs or glucose lowering drugs other than insulin
- Haemodialysis or peritoneal dialysis
- Pregnant or nursing women
The registry criteria, word for word
Show all 30 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Denmark
- Gentofte HospitalHellerup, DenmarkTaking people
About the trial
What the trial wants to find out
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.
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- The effect of colchicine, on insulin sensitivity in individuals with type 1 diabetes and systemic low-grade inflammation (INS1GHT)
- Plain-language title
- Tests colchicine for insulin sensitivity in type 1 diabetes with inflammationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 26 September 2025