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Study on Anti-T Lymphocyte Immunoglobulin for Children and Young Adults with Recent Type 1 Diabetes to Preserve Beta Cell Function

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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 trial aims to explore the effectiveness and safety of a treatment called Grafalon, which contains an active substance known as anti-T lymphocyte immunoglobulin for human use, rabbit. This treatment is given as a solution through an infusion, which means it is administered directly into the bloodstream.

The purpose of the study is to see if Grafalon can help prevent the loss of remaining insulin-producing cells in children and young adults who have been recently diagnosed with Type 1 diabetes. Participants in the study will receive either the Grafalon treatment or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will be monitored over a period of time to assess how their bodies respond to the treatment. This includes regular check-ups and tests to measure the function of their insulin-producing cells and other health indicators. The study will help determine the best dosage of Grafalon for treating Type 1 diabetes in young patients and aims to provide valuable insights into managing this condition more effectively.

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 visit

    Upon joining the study, you will attend an initial visit. During this visit, medical staff will review your medical history and perform necessary health assessments to ensure you meet the study criteria.

    You will receive detailed information about the study, including the purpose, procedures, and potential risks and benefits. You will have the opportunity to ask questions and provide informed consent to participate.

  2. Step 2

    Randomization

    After the initial visit, you will be randomly assigned to one of the study groups. This means you will either receive the study medication, Grafalon, or a placebo, which is a substance with no active medication.

    The study is double-blind, meaning neither you nor the medical staff will know which group you are in. This helps ensure the study results are unbiased.

  3. Step 3

    Treatment phase

    During the treatment phase, you will receive the study medication, Grafalon, as an infusion. An infusion is a way of delivering medication directly into your bloodstream through a vein.

    The dosage and frequency of the infusion will be determined by the study protocol. You will be monitored closely by medical staff during and after each infusion to ensure your safety.

  4. Step 4

    Follow-up visits

    You will have regular follow-up visits with the study team. These visits will include health assessments, blood tests, and other evaluations to monitor your response to the treatment.

    The study team will assess the effectiveness of the treatment by measuring specific markers in your blood, such as C-peptide levels, which indicate how well your body is producing insulin.

  5. Step 5

    End of study

    At the end of the study, you will have a final visit with the study team. This visit will include a comprehensive health assessment and a discussion of your overall experience during the study.

    The study team will provide information on any next steps or additional follow-up that may be necessary based on your participation in the study.

Who can join the trial?

4 criteria

  • You must have been diagnosed with Type 1 diabetes.
  • You should be within the age range of children and teenagers.
  • Both males and females can participate.
  • You should not belong to a vulnerable population group.

Who cannot join the trial?

3 criteria

  • Patients who do not have Type 1 diabetes cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

Grafalon is a medication used in this clinical trial to help manage Type 1 Diabetes in children and young adults. It is designed to prevent the loss of the body's ability to produce insulin by protecting the cells in the pancreas that make insulin. This medication is being tested to see if it can help maintain the function of these cells, which are often damaged in people with Type 1 Diabetes. The trial aims to find out how effective and safe Grafalon is for people who have recently been diagnosed with this condition.

What is already known about the treatment

Grafalon – Grafalon is administered as an injection and is currently being studied in clinical trials for its potential use in treating Type 1 diabetes, particularly in children and young adults. The main goal of this medication is to help preserve the function of beta cells in the pancreas, which are responsible for producing insulin. Grafalon works by modulating the immune system to prevent it from attacking these beta cells, which is a key issue in Type 1 diabetes. It is classified as an immunosuppressive agent, meaning it helps to reduce the activity of the immune system to protect the body's own cells.

Investigated diseases

Type 1 diabetes – Type 1 diabetes is a chronic condition where the pancreas produces little or no insulin, a hormone needed to allow sugar (glucose) to enter cells to produce energy. The disease typically begins in childhood or young adulthood, but it can develop at any age. It progresses as the immune system mistakenly attacks and destroys insulin-producing cells in the pancreas. Over time, this leads to high blood sugar levels, which can cause various symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. As the disease advances, it requires careful management of blood sugar levels through lifestyle adjustments and monitoring. Without insulin, the body cannot properly use glucose for energy, leading to potential complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508514-42-00Protocol codeGIRO T1DEstimated enrolment98 patientsSponsorInstitute For Clinical And Experimental Medicine

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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).