Latent autoimmune diabetes in adults Trials in Disease

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

This clinical trial is being conducted in Sweden and Norway and focuses on understanding the long-term effects of a treatment called GAD-alum in people with Latent Autoimmune Diabetes in Adults. LADA is a unique form of diabetes that develops in adults and involves the gradual loss of the body's ability to produce insulin due to an autoimmune process.

Who can participate:

• You must have previously participated in a related study called GADinLADA
• You need to sign an informed consent form, showing you understand and agree to take part in the study
• Both men and women are eligible to participate
• You must have LADA, not other types of diabetes

Who cannot participate:

• People with other types of diabetes besides LADA
• Those who did not participate in the previous GADinLADA study
• Individuals outside the specified age range for the study
• People who do not carry a specific genetic marker called HLA-DR3DQ2, which is related to the immune system
• Members of vulnerable populations who may need special protection

What the trial focuses on:

The main goal of this study is to examine whether GAD-alum treatment has lasting benefits three years after it was first given. Researchers want to understand if this treatment can help preserve the body's ability to produce insulin and maintain better blood sugar control over time. They are particularly interested in comparing results between people who carry the HLA-DR3DQ2 genetic marker and those who do not.

The investigational treatment:

The treatment being studied is GAD-alum, also known as Diamyd. This is an injection containing glutamate decarboxylase 2, a protein that works with the immune system. The treatment is injected directly into the lymph nodes, a technique called intralymphatic administration. GAD-alum is designed to reduce the autoimmune attack on the insulin-producing cells in the pancreas, potentially helping to preserve their function and slow the progression of diabetes.

Participants will undergo assessments to measure their diabetes status, including how well their bodies produce insulin and control blood sugar levels. The study is expected to conclude by March 31, 2025, and will provide valuable information about whether this immunomodulatory approach offers long-term benefits for people living with LADA.