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Taking people in IsraelNo phase

Long-term outcomes of teplizumab for type 1 diabetes in routine care

Follows people with early type 1 diabetes who receive teplizumab in routine care.

Key facts

Who runs it
Sanofi
Where
Petah Tikva and Ramat Gan, IsraelSee the 3 sitesAlso in 3 other countries, 9 sites
Trial code
Registry title
Long-Term Outcomes of Teplizumab in Routine Clinical Care
Status
Recruiting
People taking part
1,000 people, planned
Started
19 Mar 2026
Expected to end
29 Oct 2035
Type of study
Observational
Treatments tested
  • Teplizumab
Record updated
9 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with Stage 2 type 1 diabetes who have already received teplizumab in routine care. It follows how they do over time.

Sex
All sexes can join.
Disease stage
Stage 2 type 1 diabetes, confirmed by the treating doctor at the first teplizumab infusion. People who reach Stage 3 by Week 6 can still join.
Earlier treatment
Must have had at least 1 teplizumab infusion within 6 weeks before enrolling. Must not have been in an earlier teplizumab trial.

Main reasons for not taking part

  • Took part in an earlier clinical trial of teplizumab
  • Joined another clinical trial within 6 months before enrolling (observational studies are fine)

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Israel

Also in 3 other countries, 9 sites

  • Petah TikvaHospital not named in the registryTaking people
  • Ramat GanHospital not named in the registryTaking people
  • Ramat GanHospital not named in the registryTaking people

About the trial

What the trial wants to find out

This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.

The group in the trial

  • Patients with Stage 2 Type 1 Diabetes (T1D) who received Teplizumab

    Treatment: Teplizumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care
Plain-language title
Long-term outcomes of teplizumab for type 1 diabetes in routine careGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 10 November 2026.
Record updated
9 November 2026