Not a traditional drug phase: testing Teplizumab for Type 1 Diabetes
This study is a multi-country, multi-center retrospective watch-and-measure (no experimental treatment required) 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 registry: https://clinicaltrials.gov/study/NCT07457580 · Sanofi · enrollment listed as 60
What this phase means
This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.
They plan to enroll about 60 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Real-World Retrospective Observational Study Characterizing Patients With Stage 2 Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
Interventions: Teplizumab
Primary outcome (registry wording): Participant demographics at teplizumab initiation
Who it is for (from inclusion criteria)
- Patient received ≥ 1 day of teplizumab treatment as part of MAPs
Who the registry excludes
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Public study contact (from the registry)
Trial Transparency email recommended (Toll free for US & Canada)
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
16 listed- Investigational Site Number: 0560001 — Leuven, Belgium (completed)
- Investigational Site Number: 2500001 — Bron, France (completed)
- Investigational Site Number: 2500003 — Paris, France (completed)
- Investigational Site Number: 2500002 — Paris, France (completed)
- Investigational Site Number: 2760003 — Augsburg, Germany (recruiting)
- Investigational Site Number: 2760002 — Frankfurt, Germany (completed)
- Investigational Site Number: 2760001 — Hanover, Germany (completed)
- Investigational Site Number: 2760004 — Munich, Germany (recruiting)
- Investigational Site Number: 3800001 — Ancona, Italy (completed)
- Investigational Site Number: 3800003 — Palermo, Italy (completed)
- Investigational Site Number: 3800002 — Verona, Italy (completed)
- Investigational Site Number: 7240001 — Madrid, Spain (completed)
FAQ about this NCT record
Is NCT07457580 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07457580?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07457580?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary