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Clinical Trials in the EU / 2025-521397-34-00
Authorised, recruiting Phase III

Colchicine to reduce microvascular complications in people with type 1 diabetes and high glycemic variability

2025-521397-34-00 · tracked via the Priya Life Science EU tracker
Sponsor
Radboud universitair medisch centrum Stichting
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Nutritional and Metabolic Diseases
Decision date
13/10/2025
Enrollment target
80
Sites
Netherlands

Condition studied

Type 1 Diabetes

Investigational medicinal product(s)

Colchicine Teva 0,5 mgtablettenCapsules with microcrystalline cellulose

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

Changes in marker for (subclinical) diabetic retinopathy (vessel density on OCTA) during the study period

Endpoint detail

Changes in markers for (subclinical) diabetic retinopathy (e.g. micro-aneurysms, thinning of retinal layers, foveal avascular zone) during the study period, Changes in markers for (subclinical) diabetic nephropathy (plasma creatinine and urea, urinary microalbuminuria) during the study period, Changes in inflammatory parameters (e.g. circulating immune cell numbers and phenotypes, immune cell function, circulating inflammatory proteins including various pro-inflammatory cytokines, endothelial markers) during the study period, Changes in glycemic variability markers (e.g. coefficient of variation, time in range, standard deviation) as measured by the glucose sensor during the study period

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-521397-34-00 on CTIS ↗ ← All trials in the EU