Real-world outcomes for people with Type 1 diabetes treated with teplizumab through managed access programs
A Real-World Retrospective Observational Study Characterizing Patients With Stage 2 Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
This project will look at health records to see how teplizumab is being used and how people's Type 1 diabetes progressed after receiving it through managed access programs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Drugs / interventions | teplizumab |
| Locations | 4 sites (Palermo and 3 other locations) |
| Trial ID | NCT07457580 on ClinicalTrials.gov |
What this trial studies
This multi-country, multi-center retrospective cohort study uses chart reviews and other secondary clinical data to describe patients with Type 1 diabetes who received teplizumab via managed access programs. It will capture patient characteristics, relevant comorbidities, monitoring and treatment practices, and time to disease progression after treatment. The design was chosen to provide rapid, real-world insight into current clinical use of teplizumab outside interventional trials. No investigational procedures are being administered as part of this observational data collection.
Who should consider this trial
Good fit: People with Type 1 diabetes who received at least one day of teplizumab through a managed access program and who provide informed consent (or meet local consent waiver criteria) are the intended participants.
Not a fit: People who never received teplizumab, or who were participating in an interventional clinical study at the time of treatment, are unlikely to be included or to gain direct benefit from this observational analysis.
Why it matters
Potential benefit: If successful, this could help clinicians understand real-world effects of teplizumab and identify which patients may benefit most from the treatment.
How similar studies have performed: Randomized clinical trials have shown that teplizumab can delay progression to clinical Type 1 diabetes in high‑risk individuals, but published real‑world data from managed access programs are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Palermo and 3 other locations
- Investigational Site Number: 3800003 — Palermo, Italy (Recruiting)
- Investigational Site Number: 7240001 — Madrid, Spain (Recruiting)
- Investigational Site Number: 7240002 — Madrid, Spain (Recruiting)
- Investigational Site Number: 8260002 — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: contact-us@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.