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Could a 14-Day drug delay diabetes in toddlers?

NCT ID NCT05757713

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a drug called teplizumab in 20 children under 8 who have early signs of type 1 diabetes (Stage 2). The goal is to check if the drug is safe and how the body handles it. Teplizumab works by calming the immune system to protect insulin-making cells. If successful, it might delay or prevent the need for insulin shots.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
teplizumab (a drug that calms the immune system)
What this could lead to
If it works, this could help delay or prevent full-blown type 1 diabetes in very young children.
What could go wrong
This is a small, early-phase study with only 20 kids, so results may not apply to everyone. Teplizumab can cause side effects like infections or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 7 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant is a male or female 0 to \< 8 years of age, inclusive, at Day 1 2. Participant has Stage 2 T1D (two T1D-related autoantibodies and dysglycemia) Exclusion Criteria: 1. Participant has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease 2. Has an active infection and/or fever 3. Has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). 4. Has any condition that, in the opinion of the Investigator, would interfere with the study conduct or the safety of the participant.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Barbara Davis Center for Diabetes Site Number : 102

    Aurora, Colorado, 80045, United States

  • Centricity Research Site Number : 104

    Columbus, Georgia, 31904, United States

  • Children's Hospital of Philadelphia Site Number : 108

    Philadelphia, Pennsylvania, 19104, United States

  • Indianapolis University Health Riley Hospital for Children Site Number : 110

    Indianapolis, Indiana, 46202, United States

  • MulitCare Institute for Research & Innovation Site Number : 103

    Tacoma, Washington, 98405, United States

  • Sanford Diabetes and Thyroid Clinic Site Number : 106

    Sioux Falls, South Dakota, 57105, United States

  • UBMD Pediactrics Site Number : 105

    Buffalo, New York, 14203, United States

  • UCSF Medical Center Site Number : 107

    San Francisco, California, 94143, United States

  • Vanderbilt Univerity Medical Center Site Number : 109

    Nashville, Tennessee, 37232, United States

  • Yale University School of Medicine Site Number : 101

    New Haven, Connecticut, 06511, United States

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