Study on the Safety and Feasibility of Diamyd (Glutamate Decarboxylase 2) for Individuals Aged 8-17 at Risk for Type 1 Diabetes with HLA DR3-DQ2 Haplotype

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What is this study about?

This clinical trial is focused on studying Type 1 diabetes, a condition where the body’s immune system attacks insulin-producing cells in the pancreas. The study will use a treatment called Diamyd, which is a suspension for injection containing a substance known as glutamate decarboxylase 2, human, recombinant. This treatment is being tested to see if it is safe and practical for people who are at risk of developing Type 1 diabetes.

The purpose of the study is to evaluate the safety and feasibility of administering Diamyd through injections into a lymph node in the groin area. Participants in the study will receive either two or three injections, spaced one month apart. The study is open to individuals aged 8 to under 18 years who have a specific genetic marker known as the HLA DR3-DQ2 haplotype and have multiple antibodies associated with Type 1 diabetes, indicating they are at increased risk for developing the disease.

The study aims to determine if this method of administering Diamyd is a viable option for preventing or delaying the onset of Type 1 diabetes in those at risk. Participants will be monitored to assess the safety of the treatment and to gather information on how well the treatment can be administered in this way. The study is expected to continue until September 2026.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age (between 8 and 18 years), possession of the HLA DR3-DQ2 haplotype, and the presence of specific autoantibodies associated with Type 1 diabetes.

2 first injection

The first administration of Diamyd occurs. This is a suspension for injection containing a substance called glutamate decarboxylase 2, human, recombinant. The injection is given intralymphatically, meaning it is administered directly into a lymph node located in the groin area.

3 second injection

One month after the first injection, a second intralymphatic injection of Diamyd is administered. This step is crucial for evaluating the safety and feasibility of the treatment.

4 third injection (if applicable)

In some cases, a third injection may be administered one month after the second injection. This is determined based on the study’s requirements and the participant’s response to the previous injections.

5 monitoring and follow-up

Throughout the study, regular monitoring is conducted to assess the participant’s health and the treatment’s effects. This includes evaluating the safety and feasibility of the injections.

6 study completion

The study is expected to conclude by September 30, 2026. At this point, a final assessment is conducted to gather data on the long-term effects and safety of the treatment.

Who Can Join the Study?

Must have written permission from both the individual and their parents or guardians to participate.
Must be a boy or girl who is at least 8 years old but younger than 18 years old at the time of the initial screening.
Must have a specific genetic marker called HLA DR3-DQ2 haplotype.
Must test positive for GADA (an antibody related to diabetes) and at least one other antibody linked to Type 1 Diabetes, such as IA-2A, ZnT8A, or IAA.

Who Cannot Join the Study?

Individuals who do not have the specific genetic marker called HLA haplotype DR3-DQ2 cannot participate. This is a specific genetic pattern that some people have.
Individuals who do not have multiple islet autoantibodies cannot participate. These are proteins made by the immune system that mistakenly target the insulin-producing cells in the pancreas.
Individuals who are not at increased risk for Type 1 Diabetes (T1D) cannot participate. This means they do not have a higher chance of developing this type of diabetes.
Individuals who are not between the ages of 8 and less than 18 years old cannot participate. This means the study is only for people who are at least 8 years old but not yet 18.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Region Skane Skanes Universitetssjukhus	Lund	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	04.10.2024

Trial locations

Investigated drugs:

Glutamate Decarboxylase 2, Human, Recombinant

Diamyd is a medication being studied for its potential to prevent or delay the onset of Type 1 diabetes in individuals who are at increased risk. In this trial, Diamyd is administered through injections directly into the lymph nodes. The study aims to assess how safe and feasible it is to give these injections to young individuals who have specific genetic markers and are at risk of developing Type 1 diabetes.

Investigated diseases:

Type 1 diabetes mellitus

Type 1 diabetes mellitus – This is a chronic condition where the pancreas produces little or no insulin, a hormone needed to allow sugar (glucose) to enter cells to produce energy. It typically appears in children and young adults, although it can develop at any age. The disease progresses as the immune system mistakenly attacks and destroys insulin-producing cells in the pancreas. Over time, this leads to high blood sugar levels, which can cause various symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors. Managing blood sugar levels is crucial to prevent complications associated with the disease.

Trial ID:

2024-513350-30-00

Protocol code:

D/P2/22/8

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Feasibility of Diamyd (Glutamate Decarboxylase 2) for Individuals Aged 8-17 at Risk for Type 1 Diabetes with HLA DR3-DQ2 Haplotype

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?