Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Safety and Effectiveness of Diamyd and Colecalciferol for Adolescents and Adults with Recently Diagnosed Type 1 Diabetes

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Type 1 Diabetes, a condition where the body's immune system attacks the cells in the pancreas that produce insulin. The study aims to evaluate the safety and effectiveness of a treatment called Diamyd, which is a suspension for injection containing a substance known as glutamate decarboxylase 2, human, recombinant. This treatment is being tested to see if it can help preserve the function of the insulin-producing cells in people who have recently been diagnosed with Type 1 Diabetes and carry a specific genetic marker known as the HLA DR3-DQ2 haplotype. Some participants in the study may receive a placebo instead of the actual treatment.

The study will involve participants receiving three doses of Diamyd over a period of time, with the goal of assessing its impact on the body's ability to produce insulin and maintain blood sugar levels. Participants will be monitored for changes in their insulin production and blood sugar control over the course of the study. The study will also look at the safety of the treatment by tracking any side effects or reactions that occur during the trial.

In addition to Diamyd, the study will also involve the use of Divisun 2000 IE tabletter, which contains colecalciferol, commonly known as Vitamin D3. This is a vitamin supplement taken orally in tablet form. The study will last for a period of up to 24 months, during which participants will undergo regular assessments to monitor their health and the effects of the treatment. The overall aim is to determine if Diamyd can help preserve the body's natural insulin production in people with newly diagnosed Type 1 Diabetes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, recent diagnosis of type 1 diabetes, and specific genetic markers.

    Blood tests are performed to check for the presence of certain antibodies and to measure C-peptide and HbA1c levels.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the investigational drug Diamyd or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  3. Step 3

    Treatment administration

    The investigational drug Diamyd is administered as a suspension for injection through intralymphatic use. The treatment consists of three doses.

    Participants also receive Divisun tablets, containing colecalciferol, taken orally. The dosage is 2000 IE per tablet.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor health and response to treatment. This includes physical examinations, blood tests, and continuous glucose monitoring.

    Participants are observed for any adverse effects, including injection site reactions and changes in vital signs.

  5. Step 5

    Final evaluation

    At the end of the 24-month period, a final evaluation is conducted to assess changes in C-peptide levels and HbA1c, as well as overall health outcomes.

    The study aims to determine the efficacy of Diamyd in preserving insulin production and secretion.

Who can join the trial?

10 criteria

  • Must be able to provide written, signed, and dated informed consent. For minors, age-appropriate agreement and parent or caregiver consent are required.
  • Must be between 12 and 28 years old at the time of screening. In Germany, only those aged 18 to 28 will be enrolled.
  • Must have been diagnosed with **Type 1 diabetes (T1D)** within the last 6 months. T1D is a condition where the body does not produce insulin.
  • Must have a specific genetic marker called **HLA DR3-DQ2 haplotype**. This will be tested during the study.
  • Must have a **fasting C-peptide** level of at least 0.12 nmol/L. C-peptide is a substance made in the pancreas, and its level helps to understand how much insulin the body is producing.
  • Must have detectable **GAD65 antibodies**. These are proteins made by the immune system that can attack the body's own cells.
  • Must have **HbA1c** levels between 35 to 80 mmol/mol (5.4 to 9.5%). HbA1c is a measure of blood sugar levels over the past 2 to 3 months.
  • Must be on a stable insulin basal dose for one month before joining the study. This means the daily insulin dose should not change much.
  • Females who can have children must agree to avoid pregnancy and have a negative pregnancy test during the study. They must use highly effective birth control methods during treatment and for 90 days after the last dose.
  • Males must agree to avoid fathering a child during treatment and for 90 days after. If sexually active, they must use two effective birth control methods.

Who cannot join the trial?

6 criteria

  • Individuals who do not have **Type 1 diabetes mellitus**. This is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels.
  • Individuals who do not carry the **HLA DR3-DQ2 haplotype**. This is a specific genetic marker that some people with Type 1 diabetes have.
  • Individuals who do not have **antibodies against GAD65**. These are proteins made by the immune system that mistakenly attack parts of the body, in this case, related to diabetes.
  • Individuals who carry the **HLA DR4-DQ8 haplotype**. This is another genetic marker that is not included in this study.
  • Individuals who are not adolescents or adults. The study is focused on these age groups.
  • Individuals who are not recently diagnosed with Type 1 diabetes. The study is for those who have been diagnosed recently.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Diamyd is a medication being studied to see if it can help preserve the function of beta cells in the pancreas. Beta cells are important because they produce insulin, which helps control blood sugar levels. This medication is being tested in people who have recently been diagnosed with Type 1 Diabetes and have a specific genetic marker called HLA DR3-DQ2. The goal is to see if Diamyd can help maintain the body's ability to produce insulin naturally and improve blood sugar control.

What is already known about the treatment

Diamyd – Diamyd is administered as an injection and is currently being studied in clinical trials for its potential to preserve the function of insulin-producing beta cells in individuals with recently diagnosed Type 1 diabetes. The medication is in the experimental phase and is not yet widely recognized in medical literature as a standard treatment. It is primarily indicated for adolescents and adults with Type 1 diabetes who have specific genetic markers. Diamyd works by targeting the immune system to prevent it from attacking the body's own insulin-producing cells, specifically through its action on the GAD65 enzyme. It is classified as an immunomodulatory agent.

Investigated diseases

Type 1 diabetes mellitus – This is an autoimmune disease where the body's immune system mistakenly attacks and destroys insulin-producing beta cells in the pancreas. As a result, the body produces little or no insulin, a hormone necessary for glucose to enter cells and produce energy. The disease often begins in childhood or adolescence but can develop in adults. Symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. Over time, if not managed, it can lead to complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The progression involves a gradual decline in insulin production, requiring lifelong management to maintain normal blood sugar levels.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513304-33-00Protocol codeDIAGNODE-3Estimated enrolment330 patientsSponsorDiamyd Medical AB

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).