The effect of colchicine, on insulin sensitivity in individuals with type 1 diabetes and systemic low-grade inflammation (INS1GHT)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Gentofte Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19], Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

22 Dec 2025 → ongoing

Decision date (initial)

2025-09-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Herlev and Gentofte Hospital

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Conditions and MedDRA coding

Type 1 diabetes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. T1D for more than five years and c-peptid <200 pmol/L
2. Age 18–80 years
3. User of a CGM system
4. HbA1c 42-75 mmol/mol
5. Stable insulin therapy
6. eGFR ≥ 60 mL/min/L/1.73 m²
7. hsCRP ≥ 2 mg/L

Exclusion criteria 23

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in M-value after four weeks of placebo/colchicine

Secondary endpoints 6

1. Mean difference in M-value (adjusted to body surface area (BSA)
2. Mean difference in M-value (adjusted to fat free mass)
3. Mean difference in Insulin Sensitivity Index (ISI)
4. Mean difference in average daily insulin dosage
5. Fold difference in Insulin sensitivity by estimated glucose disposal rate (eGDR)
6. Fold difference in in fasting serum/plasma concentrations of inflammation markers hsCRP, IL-6, Tumour necrosis factor α

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gentofte Hospital

Sponsor organisation

Gentofte Hospital

Address

Gentofte Hospitalsvej 1

City

Hellerup

Postcode

2900

Country

Denmark

Scientific contact point

Organisation

Gentofte Hospital

Contact name

Center for Clinical Metabolic Research

Public contact point

Organisation

Gentofte Hospital

Contact name

Center for Clinical Metabolic Research

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications