Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd® to Preserve Endogenous Beta Cell Function in Adolescents and Adults with Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype

This important study, called a Phase III trial, is testing a new treatment named Diamyd for people who have recently been diagnosed with Type 1 diabetes. The main goal is to see if Diamyd can help the body continue to produce its own insulin, which is often lost in Type 1 diabetes. Researchers will compare Diamyd to a dummy treatment (placebo) to understand its effects. They will closely monitor participants' blood sugar control using measurements like HbA1c and C-peptide levels, which show how much insulin the body is making. Safety is also a key focus, with researchers looking for any side effects. This study aims to find a new way to help manage Type 1 diabetes for those with a specific genetic marker (HLA DR3-DQ2).

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Diamyd Medical AB

Enrolment target

280

Start

11 Jul 2024

Type 1 diabetes mellitus

What is this study about?

This study is looking into a new treatment called Diamyd for people who have recently found out they have Type 1 diabetes. When you have Type 1 diabetes, your body's immune system mistakenly attacks and destroys the cells in your pancreas that make insulin. Insulin is a hormone that helps your body use sugar for energy. Without enough insulin, blood sugar levels can become too high.

The main idea behind this study is to see if Diamyd can help protect some of these insulin-making cells, called beta cells, that might still be working when someone is first diagnosed. If we can keep these cells working for longer, it might make managing Type 1 diabetes easier and potentially reduce some of its long-term health problems. Researchers will carefully check how well Diamyd works compared to a 'dummy' treatment (a placebo) and also keep a close eye on safety.

This is a 'Phase III' study, which means it's one of the final steps before a new treatment might become widely available. It involves a larger number of people and aims to confirm the results seen in earlier, smaller studies. The researchers are particularly interested in people who have a specific genetic marker, HLA DR3-DQ2, which is linked to Type 1 diabetes. By focusing on this group, they hope to find out if Diamyd is especially helpful for them.

Key takeaways

This study tests a new treatment (Diamyd) for recently diagnosed Type 1 diabetes.
It aims to preserve the body's natural insulin production.
Participants will receive either Diamyd or a placebo.
The study focuses on people with a specific genetic marker (HLA DR3-DQ2).
It's a large, important study to see if Diamyd is safe and effective.
Participation involves regular follow-up over 15-24 months.

Who may be eligible?

This study is for adults and teenagers. To take part, you must have been recently diagnosed with Type 1 diabetes and also have a specific genetic marker called HLA DR3-DQ2. This marker is found through a simple blood test.

If you are a man or a woman, you can take part. There's no upper age limit, meaning older adults are welcome to participate if they meet the other criteria.

The research team will need to check your medical history and do some tests to make sure the study is a good fit for you and that taking part would be safe. They will explain all the specific requirements in detail.

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.

Are you between 18 years old and any age above that?
Have you been recently diagnosed with Type 1 diabetes?
Do you know if you have the HLA DR3-DQ2 genetic marker? (A doctor can check this)
Are you able and willing to attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned by chance to receive either the Diamyd treatment or a placebo (a dummy treatment that looks just like Diamyd but has no active medicine). Neither you nor your study doctor will know which treatment you are receiving, which helps make the study fair and accurate. You will also receive Divisun 2000 IE tablets.

The study involves regular visits to the clinic over a period of about 15 to 24 months. During these visits, you will have blood tests to measure your insulin production (like C-peptide) and blood sugar control (like HbA1c). You will also have tests to monitor your overall health, including physical examinations, checking your blood pressure and heart rate, and providing urine samples. Some participants may also wear a continuous glucose monitor (CGM) to track their blood sugar levels constantly.

Researchers will also monitor any side effects or changes in your health throughout the study to make sure the treatment is safe for you. The total duration of your involvement in the study could be up to two years.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment before it's widely available, and you'll receive close medical supervision. The potential benefit of this study is that Diamyd might help your body continue to produce its own insulin, which could make managing your Type 1 diabetes easier. However, there's no guarantee it will work for everyone, or that it will work at all. As with any treatment, there are potential risks, including side effects from the medication or discomfort from blood tests and injections. These will be carefully explained to you, and the study team will monitor you closely for any issues. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (8)

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

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Unverified
Germany
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Unverified
Spain
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Unverified
Czechia
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Unverified
Netherlands
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Unverified
Hungary
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Unverified
Estonia
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Unverified
Sweden
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Unverified
Poland

Common questions

What is Type 1 diabetes?

Type 1 diabetes is a condition where your body's immune system attacks and destroys the cells that make insulin, a hormone needed to control blood sugar. This means you need to take insulin to manage your blood sugar levels.

What does 'Phase III trial' mean?

A Phase III trial is a large study that compares a new treatment to existing treatments or a placebo to confirm its effectiveness and safety before it can be approved for wider use.

What is the HLA DR3-DQ2 genetic marker?

This is a specific genetic marker that some people with Type 1 diabetes have. Researchers are studying if Diamyd is particularly helpful for those with this marker.

Will I know if I'm getting the real medicine or a dummy treatment?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know if you're receiving Diamyd or the placebo. This helps ensure fair and unbiased results.

How long will I be in the study?

Your participation in the study could last for about 15 to 24 months, with regular visits and monitoring.