Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

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

This study, called DiaPrecise, is investigating a new treatment called Diamyd for individuals who are at risk of developing type 1 diabetes. The main goal is to find out if giving two or three injections of Diamyd directly into a lymph node (a small gland that's part of your immune system, located in your groin) is safe and practical. Researchers are also interested in understanding how the body reacts to this treatment. This is a Phase II study, meaning it's an early step to gather information about the treatment's effects and safety before it can be tested in larger groups of people. For now, all ages and sexes may be considered.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Diamyd Medical AB

Enrolment target

Start

19 Jun 2024

Type 1 diabetes mellitus

What is this study about?

This research study, named DiaPrecise, is focused on finding new ways to help people who are at risk of developing type 1 diabetes. Type 1 diabetes happens when the body's immune system mistakenly attacks and destroys the cells in the pancreas that produce insulin. Insulin is a hormone that helps your body use sugar for energy. Without enough insulin, blood sugar levels can become too high, leading to serious health problems.

The study is investigating a new treatment called Diamyd. Researchers believe that Diamyd might help to protect the insulin-producing cells in people who are at risk. They want to see if gently injecting Diamyd directly into a lymph node, which is an important part of your immune system, can teach the immune system not to attack these cells. This is an exploratory study, meaning it's one of the first times this approach is being tested in this way.

The main purpose of this study is to carefully check if these injections are safe and if it's practical to give them in this way. Scientists will be looking closely at any side effects and how the body responds to the treatment. The findings from this study will be very important in deciding whether this treatment should be investigated further in larger studies, bringing us closer to potentially preventing type 1 diabetes.

Key takeaways

This study is for people at risk of type 1 diabetes.
It's testing a new treatment called Diamyd.
The treatment involves injections into a lymph node.
The main goal is to check for safety and feasibility.
This is an early-stage research study (Phase II).

Who may be eligible?

To be considered for this study, you would need to be at risk of developing type 1 diabetes. Researchers are specifically looking for people who have a particular genetic marker called HLA DR3-DQ2. This marker indicates a higher risk for type 1 diabetes.

There are no age or sex restrictions for this study, meaning that people of all ages and genders who fit the risk criteria mentioned above might be able to take part. The research team will need to do some tests to confirm if you meet all the specific requirements for the study.

Don't worry if these terms sound complicated; the study staff will explain everything clearly and check if you're a good fit. They will make sure you understand why certain criteria are important for the safety and success of the study.

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.

Am I at risk for type 1 diabetes?
Have I been told I have the HLA DR3-DQ2 genetic marker?
Am I comfortable with injections?
Am I able to attend regular clinic visits for monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either two or three injections of the study medicine, Diamyd. These injections would be given directly into a lymph node in your groin area. Before, during, and after these injections, you would have several visits to the study clinic. These visits would involve various assessments, such as blood tests, physical examinations, and detailed health checks, to monitor your health and how you are responding to the treatment.

The study will also involve regular follow-up appointments over a period of time to keep track of your health and any long-term effects. The total duration of your participation, including all treatments and follow-up, will be explained fully by the study team. They will ensure you know what to expect at each step.

Potential risks and benefits

Taking part in a clinical trial offers the chance to contribute to medical research and potentially receive a new treatment that might help prevent type 1 diabetes. However, like all medications and procedures, there could be risks, such as local discomfort or bruising from the injections, or other side effects from the Diamyd treatment itself. These will be carefully monitored. You will be fully informed of all known and potential risks before you decide to participate, and importantly, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What is type 1 diabetes?

Type 1 diabetes is a condition where your body's immune system mistakenly attacks and destroys the cells in your pancreas that produce insulin, a hormone vital for controlling blood sugar.

What is Diamyd?

Diamyd is a new treatment being studied, designed to help prevent the immune system from attacking the insulin-producing cells in people at risk of type 1 diabetes.

What is a Phase II study?

A Phase II study is an early stage of clinical research. It mainly focuses on checking if a new treatment is safe and if it works as expected, before testing it in larger groups.

What is a lymph node injection?

This means the study medicine will be injected directly into a lymph node, which is a small gland that's part of your immune system, often located in the groin.

Can I get type 1 diabetes from the Diamyd treatment?

No, the Diamyd treatment itself is not expected to cause type 1 diabetes. The purpose of the study is to explore if it can help reduce the risk.