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Teplizumab's Real-World impact on type 1 diabetes under scrutiny

NCT ID NCT07360080

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times

Summary

This study follows 1,000 people with Stage 2 Type 1 Diabetes who have received teplizumab in routine care. Researchers will track how long it takes for the disease to progress to Stage 3 and assess quality of life. The goal is to see if teplizumab delays the need for insulin therapy in everyday medical practice.

What this could mean

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

Active substance
teplizumab
What this could lead to
If successful, this study could confirm that teplizumab effectively delays the onset of full-blown Type 1 Diabetes in real-world settings, improving long-term disease management.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by factors like patient selection. Teplizumab may not work for everyone, and side effects are possible.

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.

Participants

About 1,000 people

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

Started

Mar 2026

Expected to finish

Oct 2035

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.

Who is studied

Patients diagnosed with Stage 2 T1D who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment. Approximately 1000 participants, in 85 sites across 19 countries will be enrolled over 5 years.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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 - * Participants who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment. * Participants must have a confirmed diagnosis of Stage 2 T1D according to the treating physician at the time of the first infusion of teplizumab. (Note: Participants who progress to Stage 3 T1D by Week 6 will still be eligible, provided they were in Stage 2 at the time of the first teplizumab infusion.) • Participants (or their legal guardians, as applicable) who provide appropriate written or electronic informed consent/assent as applicable for the age of the participant and as per local regulations. Exclusion Criteria - * Participants who had participated in a previous clinical trial for teplizumab. * Participants enrolled in a clinical trial within 6 months prior to study enrollment. (Note: Participants enrolled in other observational studies may be included.) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

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

Type 1 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Investigational Site Number: 3760001

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Investigational Site Number: 3760002

    RECRUITING

    Ramat Gan, 52621, Israel

  • Investigational Site Number: 3760003

    RECRUITING

    Petah Tikva, 4920235, Israel

  • Investigational Site Number: 7840001

    RECRUITING

    Abu Dhabi, United Arab Emirates

  • Investigational Site Number: 7840002

    RECRUITING

    Abu Dhabi, United Arab Emirates

  • Investigational Site Number: 8400001

    RECRUITING

    New York, New York, 10016, United States

  • Investigational Site Number: 8400002

    RECRUITING

    Syosset, New York, 11791, United States

  • Investigational Site Number: 8400003

    RECRUITING

    Atlanta, Georgia, 30318-2538, United States

  • Investigational Site Number: 8400004

    RECRUITING

    Atlanta, Georgia, 30329-3102, United States

  • Investigational Site Number: 8400005

    RECRUITING

    Sandy City, Utah, 84093, United States

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