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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

NCT ID: NCT07457580

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Teplizumab (drug)
How long the study runs
Study runs about 8 months (dates as stated)
About the drug or intervention
Teplizumab — drug: This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at real-world information from people with type 1 diabetes who were treated with a medicine called teplizumab through Managed Access Programs (MAPs), which are ways for patients to get a medicine outside of normal approval routes. The study is funded by Sanofi. It uses data from people who have already received the treatment, rather than testing it on new patients.

Who can take part

  • The patient (or parent, if under 18) gave written or electronic permission (consent) before any study activity, following local rules or an approved waiver.
  • The patient received at least one day of teplizumab treatment as part of a Managed Access Program (MAP).

Who may not be able to

  • The patient was taking part in another study that tests a treatment or procedure, starting that treatment or control on the index date. This means a study that asks patients to follow a plan that differs from normal care.

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
Not specified
Who
All
Number of participants
60
Started
2026-03-16
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for type 1 diabetes
  • • Clinical study - 60 participants
  • • 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)

Who can take part?

  • • Adults
  • • Diagnosed with type 1 diabetes

Where?

  • • Birmingham - Investigational Site Number: 8260001
  • • London - Investigational Site Number: 8260002

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Type 1 Diabetes

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: Not specified
  • Who can join: All genders

What the study is looking for

  • ✓Patient written or electronic agreement to take part or assent (for patients \< 18 years old) according to local...
  • ✓Patient received ≥ 1 day of teplizumab treatment as part of MAPs.

Who cannot take part

  • ✗The above information is not intended to contain all considerations relevant to a patient's potential participation...
See the full 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 Is This Study? (2 UK sites)

Investigational Site Number: 8260001

Birmingham B4 6NH, United Kingdom

Recruiting

Investigational Site Number: 8260002

London E1 1BB, United Kingdom

Recruiting

How to Get in Touch

Trial Transparency email recommended (Toll free for US & Canada)

Sponsor contact

CONTACT

800-633-1610 contact-us@sanofi.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08