Anti-inflammatory drug to prevent complications in type 1 diabetes

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Radboud universitair medisch centrum Stichting

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

15 Dec 2025 → ongoing

Decision date (initial)

2025-10-13

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The main objective of this trial is to determine whether colchicine can affect markers of microvascular complications (diabetic retinopathy and nephropathy) in people with type 1 diabetes and high glycemic variability.

Secondary objectives 1

1. The secondary objectives of this trial are to determine whether colchicine reduces inflammation and glycemic variability in people with type 1 diabetes and high glycemic variability.

Conditions and MedDRA coding

Type 1 Diabetes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Type 1 diabetes for at least 5 years
2. Age 18-65 years
3. HbA1c lower or equal to 100 mmol/mol
4. High glycemic variability: coefficent of variation of at least 30%
5. Use of continuous glucose monitor for at least 3 months prior to start of the study
6. Refractive error between -6 and +6 Diopters (calculated as spherical equivalent and before any treatments)

Exclusion criteria 16

1. Presence of other auto-inflammatory/-immune disease, except for celiac disease, vitiligo, or well-treated thyroid disease
2. Colchicine or other anti-inflammatory drug use
3. Active infection or illness in the past 14 days before blood collection (timing of blood collection can be adjusted)
4. Any vaccination in the past 4 weeks before blood collection (timing of blood collection can be adjusted)
5. Habitual smoking, i.e. one or more cigarettes per day (in the last half year)
6. Current or history of alcohol and/or drugs abuse (i.e. >14 units per week)
7. Proliferative diabetic retinopathy or presence of (diabetic) macula edema
8. Ophthalmological treatments in the past: retinal surgery, panretinal or focal laser photocoagulation, intravitreal injections with steroids or intravascular endothelial growth factor inhibitors
9. Any other ophthalmological treatments in the past 3 months prior to the start of the study or planned during the study period
10. Any other ophthalmological condition that can interfere with the diagnosis or progression of diabetic retinopathy (vascular occlusions, age-related macular degeneration, intra- or subretinal fluid, severe glaucoma, significant media opacities that hinder visualisation of the retina (e.g. mature cataract))
11. Women who are pregnant, breastfeeding, or trying to conceive in the period between the screening and until 3 months after the last study visit (self-reported)
12. Male partners of women trying to conceive in the period between the screening and until 6 months after the last study visit (self-reported)
13. Known blood dyscrasias
14. Regular use of CYP3A4 inhibitors, P-glycoprotein inhibitors, fibrates, ciclosporin, and digoxin, as a contraindication for colchicine
15. Nephropathy (G3aA2 or worse)
16. Having moderate to severe hepatic disease

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 4

1. Changes in markers for (subclinical) diabetic retinopathy (e.g. micro-aneurysms, thinning of retinal layers, foveal avascular zone) during the study period
2. Changes in markers for (subclinical) diabetic nephropathy (plasma creatinine and urea, urinary microalbuminuria) during the study period
3. 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
4. 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

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Radboud universitair medisch centrum Stichting

Sponsor organisation

Radboud universitair medisch centrum Stichting

Address

Geert Grooteplein Zuid 10

City

Nijmegen

Postcode

6525 GA

Country

Netherlands

Scientific contact point

Organisation

Radboud universitair medisch centrum Stichting

Contact name

Rick Meijer

Public contact point

Organisation

Radboud universitair medisch centrum Stichting

Contact name

Rick Meijer

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 5 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