RecruitingPhase 2NCT05683990

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


Sponsor

Diamyd Medical AB

Enrollment

16 participants

Start Date

Jul 9, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 8 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called Diamyd® (GAD-alum) can safely slow or prevent the development of type 1 diabetes in children and teenagers who carry certain genetic risk factors and show early signs that their immune system may be attacking their pancreas. **You may be eligible if...** - You are between 8 and 17 years old - You carry the HLA DR3-DQ2 genetic marker (a gene linked to higher type 1 diabetes risk) - You have tested positive for GADA antibodies and at least one other diabetes-related autoantibody - You do not yet have a diagnosis of type 1 diabetes - Your blood sugar and HbA1c levels are in the normal range **You may NOT be eligible if...** - You have already been diagnosed with type 1 diabetes - You are currently taking insulin or any anti-diabetic medication - You have used immune-suppressing medications in the past year - You are enrolled in another clinical drug trial - You have a history of epilepsy, serious head trauma, or hyperparathyroidism Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDiamyd

4 μg (0.1 mL) of Diamyd administered 1 month apart.


Locations(1)

Lund University/CRC, Skåne University Hospital,

Malmo, Sweden

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NCT05683990


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