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Study on the Effects of Siplizumab in Adults with New Onset Type 1 Diabetes

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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 new onset type 1 diabetes, a condition where the body's immune system attacks the cells in the pancreas that produce insulin. The study will explore the effects of a treatment called siplizumab, also known by its code name TCD601. Siplizumab is a type of medication given through an injection or infusion, which means it is delivered directly into the bloodstream. The purpose of the study is to understand how siplizumab affects the function of the insulin-producing cells in people who have recently been diagnosed with type 1 diabetes.

Participants in the study will be randomly assigned to receive either siplizumab or a placebo, which is a substance with no active medication. The study will last for 12 months, during which time the effects of the treatment on the participants' diabetes will be closely monitored. The main focus will be on how well the insulin-producing cells are working after 12 weeks of treatment, with assessments continuing until the end of the study at week 52.

Throughout the study, participants will undergo various tests to measure changes in their diabetes management, including blood sugar levels and insulin use. The study will also track any side effects or health issues that may arise during the treatment period. This research aims to provide valuable insights into the potential benefits of siplizumab for 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

    Joining the study

    Upon joining the study, the participant will be randomly assigned to receive either the study drug, siplizumab, or a placebo. This process is single-blind, meaning the participant will not know which treatment they are receiving.

  2. Step 2

    Initial treatment phase

    The participant will begin a 12-week treatment phase. During this time, siplizumab will be administered through an injection. The specific route of administration may be intravenous, subcutaneous, or intramuscular, depending on the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, regular monitoring and assessments will be conducted. This includes measuring the function of beta cells in the pancreas, which are responsible for insulin production. The primary goal is to observe any changes in beta-cell function at week 52 compared to the baseline.

  4. Step 4

    Use of additional medications

    Participants may be required to take additional medications such as paracetamol (500 mg film-coated tablets) and cetirizine dihydrochloride (10 mg film-coated tablets) as needed, following the study guidelines.

  5. Step 5

    Completion of the study

    The study will conclude after 12 months. At this point, the participant's data will be analyzed to determine the effect of siplizumab on their condition compared to the placebo group.

Who can join the trial?

12 criteria

  • Must be able to understand what the study involves and agree to participate by signing a consent form.
  • Must be a male or female between the ages of 18 and 45.
  • Must have been diagnosed with **Type 1 Diabetes (T1D)** by a healthcare provider following specific guidelines within 100 days before starting the study.
  • Must test positive for at least one **diabetes-related autoantibody**. These are proteins made by the immune system that mistakenly target parts of the body, such as:
    • **Glutamate decarboxylase (GAD-65)**
    • **Insulin**, if tested before and up to 10 days after starting insulin treatment
    • **Insulinoma antigen-2 (IA-2)**
    • **Zinc transporter-8 (ZnT8)**
    • **Islet cell autoantibodies (ICA)**, which target proteins in the insulin-producing cells
    • Must have a **C-peptide level** greater than 0.2 pmol/mL after a special meal test. This test checks how well the body is producing insulin.
    • Must agree to follow guidelines for keeping blood sugar levels under control, aiming for an **HbA1c** level of 7.0% or lower. **HbA1c** is a measure of average blood sugar over a few months.
    • Must agree to use a **Continuous Glucose Monitor (CGM)** from the start of the study until it ends at Week 52. A CGM is a device that tracks blood sugar levels throughout the day and night.
    • Must have up-to-date vaccinations or agree to get routine vaccinations according to local or national guidelines. This includes following guidelines for people with weakened immune systems or chronic diseases before starting the study treatment.

Who cannot join the trial?

8 criteria

  • Individuals who have not been recently diagnosed with **type I diabetes**. This means the study is only for those who have just found out they have this condition.
  • People who are not within the specified age range for the study. The study has a specific age group it is focusing on.
  • Participants who are not able to follow the study procedures or take the study medication as required.
  • Individuals with other medical conditions that might interfere with the study or make participation unsafe.
  • Women who are pregnant or breastfeeding, as the study may not be safe for them or their babies.
  • People who are currently participating in another clinical trial, as this could affect the results of the study.
  • Individuals who have a history of allergic reactions to the study medication or similar medications.
  • Anyone who has a condition that affects their immune system, as this could interfere with the study's focus on the immune response.
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Investigated drugs

Siplizumab is a medication being studied for its potential to help people with newly diagnosed type 1 diabetes. The trial aims to see if siplizumab can improve the function of beta cells in the pancreas, which are responsible for producing insulin. The study involves treating patients with siplizumab for 12 weeks and then observing the effects on their beta-cell function over a year.

What is already known about the treatment

Siplizumab – Siplizumab is administered through an injection, typically under the skin. It is currently being studied in clinical trials for its potential use in treating new onset type 1 diabetes. The main therapeutic indication is to help preserve the function of beta cells in the pancreas, which are responsible for producing insulin. At the molecular level, siplizumab works by targeting specific immune cells that may attack the pancreas, thereby reducing inflammation and preserving beta-cell function. It is classified as a monoclonal antibody, which is a type of medication designed to interact with specific proteins in the immune system.

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. It typically appears in adolescence or early adulthood but can develop at any age. The disease progresses as the immune system mistakenly attacks and destroys insulin-producing beta 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 condition advances, it requires careful management of blood sugar levels through lifestyle changes and insulin therapy.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506837-31-00Protocol codeTCD601F201Estimated enrolment143 patientsSponsorItb-Med AB

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