Real-world outcomes for people with Type 1 diabetes treated with teplizumab through managed access programs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Investigational Site Number: 2760003
  Augsburg, Germany Recruiting
• Investigational Site Number: 2760004
  Munich, Germany Recruiting
• 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

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: contact-us@sanofi.com
• Phone: 800-633-1610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term outcomes of teplizumab in routine care

  This project will see if teplizumab given to people with Stage 2 Type 1 Diabetes delays the start of Stage 3 diabetes and how it affects their quality of life over time.

  Recruiting at 12 sites Sanofi · Washington D.C., District of Columbia and 11 other locations · NCT07360080

• Real-world comparison of experiences for people with stage 2 type 1 diabetes who did or did not receive teplizumab

  This study will compare real-world experiences, quality of life, and disease progression for people aged 8 and older with stage 2 type 1 diabetes who received teplizumab versus similar people who did not.

  Recruiting Sanofi · San Francisco, California · NCT07260110

• Registry for patients with Stage 2 Type 1 Diabetes

  This study is looking to see how well the treatment TZIELD can help people with Stage 2 Type 1 Diabetes by tracking their health over time compared to those who aren't using the treatment.

  Recruiting at 37 sites Sanofi · Los Angeles, California and 36 other locations · NCT06481904

• Impact of GLP-1Ra on Metabolic Outcomes in Early Stage Type 1 Diabetes

  This study is testing if a new diabetes drug can help people with early stage Type 1 Diabetes improve their blood sugar control and heart health while they are also getting another treatment.

  Recruiting Early Phase 1 Vanderbilt University Medical Center · Nashville, Tennessee · NCT06338553

• Semaglutide on body composition in adults with type 1 diabetes and overweight/obesity

  This study tests whether weekly semaglutide changes body composition in adults with type 1 diabetes who are overweight or obese, compared with a placebo over 24 weeks.

  Recruiting Phase 2/3 McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT07891156

• Next Generation Extended Wear Sensors in Type 1 and Type 2 Diabetes

  This study tests a new extended wear sensor and algorithm in people with type 1 or type 2 diabetes to see how well it works across adults and children.

  Recruiting at 11 sites Medtronic MiniMed, Inc. · Chula Vista, California and 17 other locations · NCT07864168

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.