NCT07247734

The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation

The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation: A Randomized, Double-Blind, Placebo-Controlled, Investigator-Initiated Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Asger Lund, MD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim for this clinical trial is to evaluate if colchicine in addition to standard of care improves insulin sensitivity in individuals with type 1 diabetes, systemic low-grade inflammaiton and reduced insulin sensitivity. The insulin sensitivity will be evaluated by a hyperinsulinemic, euglycemic clamp.

Conditions

• Type 1 Diabetes
• Chronic Inflammation
• Insulin Sensitivity

Interventions

Type	Name	Description
DRUG	Colchicin 0.5 mg once daily for two weeks, then twice daily for two weeks	Colchicine treatment in the first period
DRUG	Placebo once daily for two weeks, then twice daily for two weeks	Placebo treatment in the first period
DRUG	Colchicine tablet 0.5 mg once-daily for two weeks, then twice daily for two weeks	Colchicine treatment in the second period
DRUG	Placebo once daily for two weeks, then twice daily for two weeks	Placebo treatment in the second period

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-22
• Completion: 2027-06-22
• First posted: 2025-11-25
• Last updated: 2025-12-23

Locations

1 site across 1 country: Denmark