Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)

NCT07457580 · tracked via the Priya Life Science Spain tracker

Sponsor

Sanofi

Phase

Observational

Started

2026-03-16

Last updated

2026-08-26

Condition(s) studied

Type 1 Diabetes

Investigational drug(s) / intervention(s)

Teplizumab →

Teplizumab: This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: • 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.

Primary outcome measure(s)

Participant demographics at teplizumab initiation — At Day 1 (first dose of teplizumab)
Age, sex at birth, height, weight, Body mass index (BMI), body surface area
Participants' family history of T1D and autoimmune diseases — At Day 1 (first dose of teplizumab)
First- and second-degree relatives with T1D
Presence of T1D susceptibility genes — At Day 1 (first dose of teplizumab)
Genetic risk score
Presence of T1D susceptibility genes — At Day 1 (first dose of teplizumab)
Human Leukocyte Antigen (HLA)-haplotype
Participants' medical history — From 6 months prior to the first dose of teplizumab (teplizumab initiation) (or the earliest date of all data contributing to Stage 2 T1D diagnosis, whichever is earlier) up to medical records abstraction date, approximately 3-4 years
Date of stage 1 confirmation, date of dysglycemia confirmation

Trial sites (14)

Facility	City	Region	Status
Investigational Site Number: 0560001	Leuven	Belgium	Recruiting
Investigational Site Number: 2500001	Bron	France	Recruiting
Investigational Site Number: 2500003	Paris	France	Recruiting
Investigational Site Number: 2500002	Paris	France	Recruiting
Investigational Site Number: 2760002	Frankfurt	Germany	Recruiting
Investigational Site Number: 2760001	Hanover	Germany	Recruiting
Investigational Site Number: 3800001	Ancona	Italy	Recruiting
Investigational Site Number: 3800003	Palermo	Italy	Recruiting
Investigational Site Number: 3800002	Verona	Italy	Recruiting
Investigational Site Number: 7240001	Madrid	Spain	Recruiting
Investigational Site Number: 7240002	Madrid	Spain	Recruiting
Investigational Site Number: 7240003	Zaragoza	Spain	Recruiting
Investigational Site Number: 8260001	Birmingham	United Kingdom	Recruiting
Investigational Site Number: 8260002	London	United Kingdom	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07457580 on ClinicalTrials.gov ↗ ← All trials in Spain