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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
DiaPrecise, A Phase II Open Label Study to Evaluate the Safety and Feasibility of Intralymphatic Administration of Diamyd® in Individuals at Risk for Type 1 Diabetes Carrying the HLA DR3-DQ2 Haplotype

Clinical Trial Summary

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

Clinical Trial Description

The trial is a 2-arm, randomized, open label clinical trial in individuals aged 8 - <18 years with HLA DR3-DQ2 and multiple islet autoantibodies (Stage 1 or Stage 2) at increased risk for T1D. At baseline eligible individuals at risk of T1D will be randomized 1:1 into 2 or 3 injections of Diamyd® administered into an inguinal lymph node. Subjects will be followed for a total of 12 months post-enrollment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05683990
Study type Interventional
Source Diamyd Medical AB
Contact Chief Operating Officer
Phone +46 (0) 8 661 00 26
Email clinicaltrials@diamyd.com
Status Recruiting
Phase Phase 2
Start date November 14, 2023
Completion date February 28, 2025
View Details
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