Looking back at people with type 1 diabetes who received teplizumab through access programs
Reviews medical records of people with early type 1 diabetes given teplizumab.
Key facts
- Who runs it
- Sanofi
- Where
- Augsburg, Frankfurt, Hanover, and Munich, GermanySee the 4 sitesAlso in 5 other countries, 12 sites
- Trial code
- Registry title
- Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 16 Mar 2026
- Expected to end
- 30 Nov 2026
- 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 study looks at people with stage 2 type 1 diabetes who got at least 1 day of teplizumab through a Managed Access Program. It reviews their past medical charts.
- Sex
- All sexes can join.
- Disease stage
- Stage 2 type 1 diabetes.
- Earlier treatment
- Must have received at least 1 day of teplizumab treatment as part of a Managed Access Program.
Main reasons for not taking part
- Taking part in an interventional clinical study on the index date
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- Patient written or electronic informed consent or assent (for patients < 18 years old) according to local regulations or appropriate informed consent waivers prior to any study related activity
- Patient received ≥ 1 day of teplizumab treatment as part of MAPs
Who cannot take part
- Participation in an interventional clinical study on the index date. Participation in an interventional clinical study is defined as initiating the product/procedure or control under investigation. An interventional clinical study is a study that requires deviation from standard clinical practice by following a study protocol; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Where in Germany
Also in 5 other countries, 12 sites
- AugsburgHospital not named in the registryTaking people
- FrankfurtHospital not named in the registryNo longer taking part
- HanoverHospital not named in the registryNo longer taking part
- MunichHospital not named in the registryTaking people
About the trial
What the trial wants to find out
This study is a multi-country, multi-center retrospective observational cohort study based on secondary data collected via chart review, with the aim of describing patient characteristics (including relevant comorbidities), monitoring and treatment practices related to Type 1 diabetes mellitus (T1D) progression, and time to T1D progression in participants who received teplizumab as part of Managed Access Programs (MAPs). This study design was chosen in order to gain rapid insight into the current use of teplizumab in clinical practice and the characteristics of patients who received the treatment.
The group in the trial
- Patients with Stage 2 Type 1 Diabetes (T1D) who received Teplizumab
Treatment: Teplizumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Real-World Retrospective Observational Study Characterizing Patients With Stage 2 Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
- Plain-language title
- Looking back at people with type 1 diabetes who received teplizumab through access programsGenerated 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