Description of Patients With Type 1 Diabetes Treated With Teplizumab

Completed

Conditions studied: Type 1 Diabetes

In brief

Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease caused by the destruction of pancreatic β cells. T1D pathogenesis progresses through several stages: Stage 1 T1D includes the presence of β cell autoimmunity and thus presence of islet autoantibodies, without the presence of dysglycemia and symptoms. Stage 2 T1D includes the presence of islet autoantibodies and dysglycemia, also with no symptoms. Stage 3 T1D includes presence of islet autoantibodies, overt hyperglycemia, and symptoms; most patients with Stage 3 T1D meet standard diagnostic criteria for diabetes and require insulin treatment. Teplizumab has been shown to delay progression to Stage 3 in participants at Stage 2 in a Phase 2 clinical trial, leading to subsequent approval in the United States of America (USA). Patients outside of the USA are able to receive the treatment through Pre-Registration Import Licenses and Managed Access Programs. The current study will collect data on the use of teplizumab in routine care, to better understand which patients received teplizumab and how these patients were managed after they received the treatment.

Key facts

Study ID

NCT06892002

Run by

Sanofi

People needed

110

Starts

2025-02-11

Expected to finish

2025-08-05

Last updated by the study team

2025-08-15

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient 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.

You may not qualify if…

• 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.

Where it is running

• Arkansas Children's Hospital Research Institute — Little Rock, Arkansas, United States
• University of California, San Francisco — San Francisco, California, United States
• Barbara Davis Center For Childhood Diabetes — Aurora, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• University of Miami Medical Center — Miami, Florida, United States
• USF Diabetes Center — Tampa, Florida, United States
• Doctor's Clinic — Vero Beach, Florida, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• Childrens Healthcare of Atlanta — Atlanta, Georgia, United States
• Riley Hospital for Children — Carmel, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Boston Children's Hospital Division of Endocrinology — Boston, Massachusetts, United States
• Atlantic Health — Morristown, New Jersey, United States
• Hassenfeld Children's Hospital at NYU Langone — New York, New York, United States
• Morgan Stanley Children's Hospital — New York, New York, United States
• Ten's Medical PC — Staten Island, New York, United States
• SUNY Upstate Medical University PARENT — Syracuse, New York, United States
• Sanford Research/USD — Fargo, North Dakota, United States
• AM Diabetes & Endocrinology Center — Bartlett, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• El Paso Medical Research Institute — El Paso, Texas, United States
• University of Utah Hospitals & Clinics — Salt Lake City, Utah, United States
• Diabetes and Endocrine Treatment Specialists — Sandy City, Utah, United States
• Schneider Children's Medical Center — Petah Tikva, Israel

Full record on ClinicalTrials.gov

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