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

NCT05949281 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-01-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Colchicine 0.5 MG Oral Tablet

Colchicine 0.5 mg once-daily

DRUG

Placebo

Placebo tablet once-daily

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Asger Lund, MD

    lead OTHER

Principal Investigators

  • Asger B. Lund, MD, PhD · Center for Clinical Metabolic Research, Gentofte Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-29
Primary Completion
2031-01-15
Completion
2031-01-15

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05949281 on ClinicalTrials.gov