A follow-up project on the GADinLADA trial to test for the continued impact of HLA-DR3DQ2 on diabetes status and immune parameters 3 years after treatment with intranodal GAD-alum.
This clinical study is a long-term follow-up for adults with Latent Autoimmune Diabetes in Adults (LADA). LADA is a form of diabetes where the body's immune system slowly damages the cells that produce insulin. Participants in an earlier trial received an experimental immunotherapy called Diamyd, which was injected into a lymph node to help protect these insulin-making cells. Researchers are now checking in on participants three years after their treatment. The main aim is to find out if the treatment continues to protect natural insulin production and keep blood sugar stable over the long term. Scientists are also studying how a specific gene type (HLA-DR3DQ2) affects how well the immune system responds to the treatment. This research could help doctors understand who might benefit most from similar therapies in the future.
At a glance
What is this study about?
Latent Autoimmune Diabetes in Adults (often called LADA or type 1.5 diabetes) is a condition where the body's immune system mistakenly attacks the beta cells in the pancreas. These cells are vital because they produce insulin, the hormone that controls your blood sugar. Over time, as these cells are lost, people with LADA gradually lose the ability to make their own insulin and need to start daily insulin injections.
In an earlier study called GADinLADA, participants received an experimental injection called Diamyd (GAD-alum) directly into a lymph node. Diamyd is designed to act like a vaccine for the immune system, training it to stop attacking the pancreas so that the remaining insulin-making cells can survive. This current project is a three-year follow-up designed to see how those participants are doing today.
The researchers want to measure how much natural insulin participants can still produce compared to when they first started the original trial and at their one-year check-up. They are also looking closely at a common immune gene called HLA-DR3DQ2. Previous evidence suggests that people with this particular gene pattern might respond better to the treatment, and this study aims to see if that advantage lasts over time.
By following participants for three years, researchers hope to learn whether this approach provides long-lasting protection. Even though this study does not test a new medicine, the findings could help scientists develop targeted, long-term treatments that preserve natural insulin and delay the need for insulin therapy in adults diagnosed with LADA.
Key takeaways
- This study tracks the long-term health of adults with LADA three years after receiving the Diamyd treatment.
- It checks whether the experimental therapy continues to protect the body's natural insulin production.
- Researchers are testing how a specific immune gene (HLA-DR3DQ2) influences long-term treatment success.
- Participation involves monitoring visits and blood tests rather than receiving new doses of the medicine.
- Joining is voluntary, and you can withdraw at any time without impacting your regular diabetes care.
Who may be eligible?
This study is designed specifically for people who previously took part in the main GADinLADA clinical trial. Because it is a long-term follow-up project, new volunteers who did not receive the initial treatment in that earlier trial cannot take part.
Eligible participants must be aged 18 or older and have a confirmed diagnosis of Latent Autoimmune Diabetes in Adults (LADA). Both men and women are welcome to participate, provided they completed the earlier trial stages.
If you are unsure whether you were part of the original GADinLADA study, your diabetes specialist or the research team who managed your previous trial visits can confirm your eligibility.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with Latent Autoimmune Diabetes in Adults (LADA).
- I previously took part in the GADinLADA clinical trial.
- I am willing to attend clinic visits for blood tests and health assessments three years after my treatment.
What does participation involve?
Taking part in this follow-up study mainly involves attending clinic appointments for health checks and monitoring. Because this is an observational follow-up to the original study, you will not receive any new injections of the trial medicine.
During your visits, the research team will carry out standard health checks and blood tests. These tests measure your blood sugar control (such as HbA1c) and check your C-peptide levels, which show how much insulin your pancreas is still making on its own. The team will also take blood samples to examine your immune system and genetic markers.
You will be asked about your general health, your current diabetes medicines, and any daily insulin you might be taking. The follow-up is designed to assess your health three years after your original treatment, and your study doctor will explain exactly how many visits are needed and how long each appointment will take.
Potential risks and benefits
Locations (2)
- —UnverifiedNorway
- —UnverifiedSweden
Common questions
What is Latent Autoimmune Diabetes in Adults (LADA)?
LADA is a form of diabetes that begins in adulthood and shares features of both type 1 and type 2 diabetes. Like type 1, it is caused by the immune system attacking insulin-producing cells, but this process happens much more slowly.
Will I receive a new injection of the study drug?
No. This project is a follow-up study to check your health three years after your original treatment in the GADinLADA trial. You will not be given any new trial medication.
What is the HLA-DR3DQ2 gene mentioned in the title?
It is a common genetic marker linked to the immune system. Researchers believe people with this specific gene pattern may respond particularly well to the Diamyd treatment, and this study aims to see if that benefit lasts.
Do I have to change my current diabetes medication to take part?
No. You should continue taking your usual diabetes medicines, including insulin or tablets, exactly as prescribed by your doctor.
Can I leave the study if I change my mind?
Yes. You can withdraw from the study at any point without giving a reason. Your standard medical treatment and relationship with your doctors will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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