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A Study of Teplizumab Compared to Placebo for Blood Sugar Control in Children and Young Adults Aged 1 to 25 Years with Newly Diagnosed 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 study is looking at Type 1 Diabetes that has been recently diagnosed in people between 1 and 25 years of age. Type 1 Diabetes is a condition where the body's immune system attacks the cells in the pancreas that make insulin, which is a hormone needed to control blood sugar levels. The study will test a medication called teplizumab, which is also known by the code name SAR446681. This medication will be given through a vein as an infusion, which means it is delivered directly into the bloodstream through a needle. Some participants will receive teplizumab while others will receive placebo. The purpose of this study is to see if teplizumab works better than placebo in helping control blood sugar levels or reducing the need for mealtime insulin over 52 weeks.

Participants in this study must have been diagnosed with Type 1 Diabetes within 8 weeks before starting the study medication. They must also have certain antibodies in their blood that are related to Type 1 Diabetes, such as antibodies against glutamic acid decarboxylase, insulinoma antigen-2, zinc-transporter 8, insulin, or islet cell cytoplasmic autoantibodies. Antibodies are proteins made by the immune system that can sometimes attack the body's own tissues. The study will also measure C-peptide, which is a substance that shows how much insulin the body is still making on its own. Participants need to have a certain level of C-peptide to be eligible for the study.

During the study, doctors will check several things to see how well the treatment is working. They will measure glycated hemoglobin, also called HbA1c, which shows average blood sugar levels over time. They will count how many days participants can go without needing insulin at mealtimes. They will also use a mixed meal tolerance test to measure C-peptide levels after participants eat a standard meal. The study will use continuous glucose monitoring to track blood sugar levels throughout the day and night. Doctors will watch for low blood sugar events, which are called hypoglycemic events, and will check for any side effects or unwanted reactions to the medication. They will also measure the amount of teplizumab in the blood and check if the body develops antidrug-antibodies, which are immune responses against the medication.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period

    After joining the study, treatment will begin within 8 weeks (56 days) of receiving the diagnosis of Type 1 Diabetes.

    Treatment will be assigned randomly, meaning it will be determined by chance. This is a double-blind study, which means neither the participant nor the medical team will know whether teplizumab or placebo (an inactive substance with no medication) is being administered.

    Teplizumab is administered as an intravenous infusion, which means the medication is delivered directly into a vein through a drip. The placebo is administered in the same manner.

    The medication is provided as a concentrate for solution for infusion, which is prepared before administration.

  2. Step 2

    Treatment administration phase

    The assigned treatment (either teplizumab or placebo) will be administered through intravenous infusion.

    The infusions will be given according to a specific schedule determined by the study protocol.

    During each infusion visit, vital signs and any reactions to the treatment will be monitored.

  3. Step 3

    Main study period

    The main study period lasts 52 weeks (approximately one year).

    During this time, multiple assessments will be conducted to evaluate how well blood sugar levels are controlled.

    Regular measurements of HbA1c (glycated hemoglobin) will be taken. This is a blood test that shows the average blood sugar level over the past 2 to 3 months.

    The amount of insulin needed for meals (called prandial insulin) will be tracked. The study will monitor how many days the participant can manage without needing insulin at mealtimes.

    C-peptide levels will be measured. C-peptide is a substance produced by the pancreas that indicates how much insulin the body is still able to produce naturally.

    A mixed meal tolerance test will be performed. This test involves drinking a standardized meal replacement drink, and then blood samples are taken over a 2-hour period to measure how the body responds.

    Continuous glucose monitoring may be used. This involves wearing a small sensor that tracks blood sugar levels throughout the day and night.

    The amount of time blood sugar stays within the target range (70-180 mg/dL) will be measured. This is called time-in-range.

    Any episodes of hypoglycemia (low blood sugar) will be recorded and classified according to their severity.

    All side effects, adverse events, and any serious health problems will be documented throughout the study period.

  4. Step 4

    Safety monitoring

    Throughout the study, safety will be continuously monitored.

    Blood samples will be taken to check for antidrug antibodies. These are proteins the immune system might produce in response to the medication.

    Blood samples will also be analyzed to measure the concentration of teplizumab in the bloodstream at various time points. This helps determine how the body processes the medication.

    Any health changes, side effects, or concerns will be evaluated and recorded.

    If serious side effects occur, treatment may need to be stopped.

  5. Step 5

    Follow-up period

    After completing the 52-week main study period, there will be additional follow-up.

    The total study duration extends until approximately December 2028.

    Follow-up visits will continue to assess long-term effects and safety.

    Diabetes management and insulin requirements will continue to be monitored.

    The ability of the pancreas to produce insulin naturally will be assessed through continued C-peptide measurements.

  6. Step 6

    Special considerations for female participants

    Female participants of childbearing potential must use highly effective contraception (with less than 1% failure rate) during the treatment period and for at least 30 days after the last dose of study medication.

    Pregnancy tests will be performed at screening and within 24 hours before the first treatment administration.

    If breastfeeding, the participant must stop breastfeeding during treatment and for 20 days after the last dose. Breast milk must be pumped and discarded during this time.

Who can join the trial?

10 criteria

  • You must be between 1 and 25 years old at the time of signing the consent form
  • If you are breastfeeding, you must stop breastfeeding and pump and throw away breast milk during the study and for 20 days after the last dose of the study medicine
  • You must be able to sign a consent form and follow the study rules. If you are under 18 years old, a parent or legal guardian must also sign the consent form
  • You must have been diagnosed with Type 1 Diabetes Stage 3, which means your body has started having problems controlling blood sugar levels
  • You must be able to start the study medicine within 8 weeks (56 days) of being diagnosed with Type 1 Diabetes Stage 3
  • You must test positive for at least one diabetes-related antibody at the screening visit. These are special proteins in your blood that show your immune system is attacking the cells that make insulin. The antibodies tested are: GAD-65, IA-2, ZnT8, insulin antibodies (if tested within 14 days of starting insulin treatment), or islet cell antibodies
  • Your blood test must show a C-peptide level of at least 0.2 nmol/L. C-peptide is a substance that shows how much insulin your body is still making on its own
  • Both males and females can participate in this study
  • If you are a woman who can become pregnant, you must use a highly effective birth control method that has less than 1% chance of failure during the study and for at least 30 days after the last dose of study medicine
  • If you are a woman who can become pregnant, you must have a negative pregnancy test at the screening visit and within 24 hours before receiving the first dose of study medicine

Who cannot join the trial?

3 criteria

  • No specific exclusion criteria have been provided in the available study information. This means the detailed list of reasons why someone cannot participate in this study is not included in the current data.
  • Generally, clinical trials have exclusion criteria to protect participant safety and ensure accurate results, but these specific details are not available in the information provided.
  • If you are interested in participating, you would need to review the complete study documentation to understand all the reasons that might prevent participation.
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Investigated drugs

  • Teplizumab

    is a medication being tested in this study for people with newly diagnosed Type 1 Diabetes. It is designed to help preserve the body's ability to produce insulin by affecting the immune system. The study will compare teplizumab with placebo to see if it can help improve blood sugar control or reduce the need for mealtime insulin injections.

  • Placebo

    is an inactive treatment that looks like the real medication but contains no active medicine. It is used in the study to compare against teplizumab to help determine if teplizumab truly works.

What is already known about the treatment

Teplizumab – Teplizumab is an investigational medication given by intravenous infusion (directly into a vein) that is being studied for the treatment of recently diagnosed Type 1 Diabetes in young people aged 1 to 25 years. This drug works by targeting and modifying certain immune system cells called T-cells, which are responsible for attacking the insulin-producing cells in the pancreas, thereby helping to preserve the body's ability to produce its own insulin. It belongs to a class of medications known as immunomodulators or monoclonal antibodies, which means it adjusts how the immune system functions. The goal of treatment with teplizumab is to help patients maintain better blood sugar control and reduce their dependence on insulin injections after being newly diagnosed with Type 1 Diabetes.

Investigated diseases

Nutritional and Metabolic Diseases – This is a broad group of disorders that affect how the body processes nutrients and maintains its chemical balance. These conditions occur when the body cannot properly break down food, absorb nutrients, or regulate substances like sugars, fats, and proteins. Some of these diseases are inherited and present from birth, while others develop later in life due to factors like diet, lifestyle, or other health conditions. The diseases in this category can affect various body systems and organs, including the liver, pancreas, and endocrine glands. Symptoms vary widely depending on the specific condition but may include problems with growth, energy levels, weight, and blood sugar control. The progression of these diseases depends on the specific disorder, with some remaining stable with proper management while others may worsen over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519494-19-00Protocol codeEFC18241Estimated enrolment1 070 patientsSponsorSanofi-Aventis Recherche & Developpement

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