Long-Term Outcomes of Teplizumab for Type 1 Diabetes

This study is observing the long-term effects of teplizumab in people with Stage 2 Type 1 Diabetes (T1D). Teplizumab is a drug already being used in regular medical care. Researchers want to see how well it delays the progression to Stage 3 T1D. You could be eligible if you have Stage 2 T1D and have received at least one teplizumab infusion within the last six weeks. The study will also look at how teplizumab affects your quality of life, including emotional and social aspects. This will help us understand how the treatment works over time for many different people. The study aims to enroll 1000 participants, but its current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will watch how teplizumab is used in real-world settings. It plans to include 1000 participants.
What's involved
You will be followed for up to 10 years after starting teplizumab treatment. The study will not administer any treatment, only observe the treatment as prescribed.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years after starting teplizumab treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07360080

Long-Term Outcomes of Teplizumab in Routine Clinical Care

Recruiting
Not specifiedAll AgesObservational
Sanofi
~1,000 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Teplizumab

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time from teplizumab infusion start to the onset of Stage 3 T1D
Measured over From start of infusion to maximum of 10 years
Type 1 Diabetes
10 sites across 5 states
Israel3
Georgia2
New York2
United Arab Emirates2
Utah1
Trial Transparency email recommended (Toll free for US & Canada)
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Eligibility criteria

Inclusion

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.

Exclusion

Participants who had participated in a previous clinical trial for teplizumab.
Participants enrolled in a clinical trial within 6 months prior to study enrollment.
  • Time from teplizumab infusion start to the onset of Stage 3 T1DFrom start of infusion to maximum of 10 years