Description of Patients With Type 1 Diabetes Treated With Teplizumab

NCT ID: NCT06892002

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-11

Study Completion Date

2025-08-05

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Teplizumab treated participants

Participants who received teplizumab as part of their routine clinical care

Teplizumab

Intervention Type DRUG

This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Interventions

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Teplizumab

This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Barbara Davis Center For Childhood Diabetes

Aurora, Colorado, United States

Site Status

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

University of Miami Medical Center

Miami, Florida, United States

Site Status

USF Diabetes Center

Tampa, Florida, United States

Site Status

Doctor's Clinic

Vero Beach, Florida, United States

Site Status

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Site Status

Childrens Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status

Riley Hospital for Children

Carmel, Indiana, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

Boston Children's Hospital Division of Endocrinology

Boston, Massachusetts, United States

Site Status

Atlantic Health

Morristown, New Jersey, United States

Site Status

Hassenfeld Children's Hospital at NYU Langone

New York, New York, United States

Site Status

Morgan Stanley Children's Hospital

New York, New York, United States

Site Status

Ten's Medical PC

Staten Island, New York, United States

Site Status

SUNY Upstate Medical University PARENT

Syracuse, New York, United States

Site Status

Sanford Research/USD

Fargo, North Dakota, United States

Site Status

AM Diabetes & Endocrinology Center

Bartlett, Tennessee, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

El Paso Medical Research Institute

El Paso, Texas, United States

Site Status

University of Utah Hospitals & Clinics

Salt Lake City, Utah, United States

Site Status

Diabetes and Endocrine Treatment Specialists

Sandy City, Utah, United States

Site Status

Schneider Children's Medical Center

Petah Tikva, , Israel

Site Status

Sheba Medical Center

Ramat Gan, , Israel

Site Status

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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United States Israel

Other Identifiers

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U1111-1315-4417

Identifier Type: REGISTRY

Identifier Source: secondary_id

PDE0109

Identifier Type: -

Identifier Source: org_study_id

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