Could a 14-Day drug delay diabetes in toddlers?
NCT ID NCT05757713
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
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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
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Jul 2023
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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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
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0 to 7 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Barbara Davis Center for Diabetes Site Number : 102
Aurora, Colorado, 80045, United States
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Centricity Research Site Number : 104
Columbus, Georgia, 31904, United States
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Children's Hospital of Philadelphia Site Number : 108
Philadelphia, Pennsylvania, 19104, United States
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Indianapolis University Health Riley Hospital for Children Site Number : 110
Indianapolis, Indiana, 46202, United States
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MulitCare Institute for Research & Innovation Site Number : 103
Tacoma, Washington, 98405, United States
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Sanford Diabetes and Thyroid Clinic Site Number : 106
Sioux Falls, South Dakota, 57105, United States
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UBMD Pediactrics Site Number : 105
Buffalo, New York, 14203, United States
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UCSF Medical Center Site Number : 107
San Francisco, California, 94143, United States
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Vanderbilt Univerity Medical Center Site Number : 109
Nashville, Tennessee, 37232, United States
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Yale University School of Medicine Site Number : 101
New Haven, Connecticut, 06511, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could type 1 diabetes hide liver problems in children?
- Can a Weight-Loss drug slow stomach emptying in type 1 diabetes?
- Can pressurized oxygen tame blood sugar spikes?
- Could a virtual life-coach program help young adults tame type 1 diabetes?
- Can Real-World data improve diabetes care in pregnancy?