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Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
Sponsor: Sanofi
Summary
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.
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)
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2026-03-16
Completion Date
2026-11-30
Last Updated
2026-03-23
Healthy Volunteers
No
Conditions
Interventions
Teplizumab
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Locations (2)
Investigational Site Number: 3800003
Palermo, Italy
Investigational Site Number: 7240002
Madrid, Spain