Study on Latent Autoimmune Diabetes in Adults (LADA) Patients: Evaluating Diabetes Status 3 Years After Treatment with Glutamate Decarboxylase 2

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What is this study about?

This clinical trial is focused on studying a type of diabetes known as Latent Autoimmune Diabetes in Adults (LADA). LADA is a form of diabetes that shares characteristics with both Type 1 and Type 2 diabetes. The treatment being investigated in this study is called GAD-alum, which is a suspension for injection containing a substance known as glutamate decarboxylase 2, human, recombinant. This treatment is administered through a method called intralymphatic use, which involves injecting the treatment into the lymph nodes.

The purpose of this study is to examine the long-term effects of GAD-alum on diabetes status and immune system parameters in individuals who have previously participated in a related study. Specifically, the study aims to determine if there are differences in diabetes status between individuals who carry a specific genetic marker, known as HLA-DR3DQ2, and those who do not. This will be assessed three years after the initial treatment with GAD-alum.

Participants in this study will undergo assessments to evaluate their diabetes status, focusing on their body’s ability to produce insulin and maintain metabolic control. These assessments will help researchers understand the potential long-term benefits of GAD-alum treatment for people with LADA. The study is a follow-up to a previous trial, and it will provide valuable insights into the effectiveness of this treatment over an extended period.

1 joining the study

Participation requires a signed informed consent.

Eligibility is limited to former participants of the GADinLADA study.

2 treatment administration

The treatment involves the use of Diamyd, which is a suspension for injection.

The active substance is glutamate decarboxylase 2, human, recombinant.

The administration route is intralymphatic use.

3 monitoring and assessment

The main objective is to assess differences in diabetes status, focusing on beta cell function and metabolic control.

The assessment occurs 3 years after the initial treatment with GAD-alum.

4 end of study

The study is estimated to conclude by March 31, 2025.

Primary endpoints include changes in diabetes status variables compared to baseline and 12 months after baseline in the previous GADinLADA study.

Who Can Join the Study?

You must have signed an informed consent form. This means you agree to participate in the study and understand what it involves.
You must have been a participant in the previous GADinLADA study. This is a specific study identified by the code EudraCT 2019-002692-34.
Both men and women can participate in this study.
The study is not open to vulnerable populations, which generally means groups that might need special protection or care.

Who Cannot Join the Study?

Individuals who have a different type of diabetes other than Latent Autoimmune Diabetes in Adults (LADA) cannot participate. LADA is a form of diabetes that occurs in adults and has some features of both type 1 and type 2 diabetes.
Participants who have not been part of the previous study called GADinLADA are excluded. This study involved treatment with a substance called GAD-alum.
People who are not within the specified age range for the study cannot join. The study is looking for participants within certain age groups.
Individuals who are not carriers of a specific genetic marker called HLA-DR3DQ2 are excluded. This marker is related to the immune system.
Participants who are considered part of a vulnerable population are not eligible. A vulnerable population includes groups who may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Karolinska Institutet	Solna	Sweden

Other Sites

Site Name	City	Country	Status
Ntwtgmlwh Uvvhberrry Oj Svmzlfy Asb Tsiwqjxjtved	Trondheim	Norway

Trial status

Country	Status	Recruitment Start
Norway	Not recruiting	01.05.2024
Sweden	Not recruiting	01.05.2024

Trial locations

Investigated drugs:

Glutamate Decarboxylase 2, Human, Recombinant

GAD-alum is a treatment used in the study to see if it can affect diabetes status and immune system parameters. It was previously used in the GADinLADA study, and this follow-up trial aims to observe its long-term effects, particularly in individuals with specific genetic markers (HLA-DR3DQ2). The treatment involves administering a protein called GAD (glutamic acid decarboxylase) combined with alum, which is a substance that helps the body respond to the protein. The goal is to see if this combination can help maintain or improve the function of insulin-producing cells in the pancreas, which are important for controlling blood sugar levels.

Latent Autoimmune Diabetes in Adults (LADA) – LADA is a form of diabetes that shares characteristics with both type 1 and type 2 diabetes. It typically occurs in adults and is characterized by the gradual onset of autoimmune destruction of insulin-producing beta cells in the pancreas. Unlike type 1 diabetes, which usually develops rapidly in children or young adults, LADA progresses more slowly and may initially be misdiagnosed as type 2 diabetes. Over time, individuals with LADA may experience a decrease in insulin production, leading to increased blood sugar levels. This condition often requires insulin therapy as the disease progresses. The autoimmune nature of LADA distinguishes it from type 2 diabetes, which is primarily related to insulin resistance.

Trial ID:

2023-509021-53-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Latent Autoimmune Diabetes in Adults (LADA) Patients: Evaluating Diabetes Status 3 Years After Treatment with Glutamate Decarboxylase 2

What is this study about?

Who Can Join the Study?

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