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NCT05683990 · ClinicalTrials.gov record · last posted 2026-04-20

Study to Evaluate the Safety and Feasibility of Diamyd® in Individuals at Risk for Type 1 Diabetes

Name: Study to Evaluate the Safety and Feasibility of Diamyd® in Individuals at Risk for Type 1 Diabetes — clinical trial record (NCT05683990)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusActive, Not Recruiting

PhasePhase 2

SponsorDiamyd Medical AB

Started2024-07-09

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

A 2-arm randomized Phase II Open Label Study to evaluate the safety and feasibility of intralymphatic administration of Diamyd® (Diamyd) also known as retogatein in individuals at risk of Type 1 diabetes carrying the HLA DR3-DQ2 haplotype.

Protocol amendment history 2 changes detected by DataLookout

2026-04-21

Trial status changed: Recruiting → Active, Not Recruiting

2026-04-21

Enrollment reduced: 16 → 5 participants

Trial Details

NCT Number	NCT05683990
Lead Sponsor	Diamyd Medical AB
Conditions	Diabetes Mellitus, Type 1, Autoimmune Diseases, Prevention
Enrollment	5 participants
Start Date	2024-07-09
Primary Completion	2028-03-31 (estimated)
Study Completion	2028-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-20