NCT05683990

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Diamyd Medical AB · Industry
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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® also known as retogatein administered into an inguinal lymph node. Subjects will be followed for a total of 12 months post-enrollment.

Conditions

• Diabetes Mellitus, Type 1
• Autoimmune Diseases
• Prevention

Interventions

Type	Name	Description
DRUG	Diamyd	4 μg (0.1 mL) of Diamyd administered 1 month apart.

Timeline

• Start date: 2024-07-09
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2023-01-13
• Last updated: 2026-03-05

Locations

1 site across 1 country: Sweden