2025-522528-29-00RecruitingPhase 2
The effect of colchicine, on insulin sensitivity in individuals with type 1 diabetes and systemic low-grade inflammation (INS1GHT)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- First submitted
- 9 Jul 2025
- Start date
- 22 Dec 2025
- Lead sponsor
- Gentofte Hospital
- Diseases
- Type 1 diabetes
- EU CT number
- 2025-522528-29-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 26
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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. 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, 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
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 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
Age
- Cancer or lymphoproliferative disease unless in complete remission for > 5 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gentofte Hospital | Hellerup | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.