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ACTIVE NOT RECRUITING
NCT05949281
PHASE2

Repurposing Colchicine for Reduction of Residual Inflammatory Risk in Type 1 Diabetes

Sponsor: Asger Lund, MD

View on ClinicalTrials.gov

Summary

The aim of this clinical trial is to evaluate if colchicine in addition to standard of care improves markers of inflammation and cardiovascular disease in persons with type 1 diabetes. Participants will be assigned to either 0,5 mg colchicine daily or placebo in a 1:1 ratio for 26 weeks with the possibility of an additional 26 week extension of the intervention period. After the treatment period, there will a 5-year follow-up on all available outcome measures via electronic patient records for those who took part in the extension.

Official title: Repurposing Colchicine for Reduction of Residual Inflammatory Risk in Type 1 Diabetes: A Randomized, Double-blind, Placebo-controlled, Investigator-initiated Trial

Key Details

Gender

All

Age Range

35 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2023-08-29

Completion Date

2031-01-15

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

DRUG

Colchicine 0.5 MG Oral Tablet

Colchicine 0.5 mg once-daily

DRUG

Placebo

Placebo tablet once-daily

Locations (1)

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, Capital Region, Denmark