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RECRUITING
NCT06481904

Registry for Stage 2 Type 1 Diabetes

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin. TZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 T1D, by the United States (US) Food and Drug Administration (FDA) for adults and children aged 8 years and older with Stage 2 T1D. The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.

Official title: An Observational, Long-term Safety Study of TZIELD® (Teplizumab-mzwv) in Patients With Stage 2 Type 1 Diabetes

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2024-09-27

Completion Date

2037-01-15

Last Updated

2026-02-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

TZIELD (teplizumab-mzwv)

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

Locations (34)

University of California Los Angeles Health- Site Number : 8400020

Los Angeles, California, United States

University of California San Francisco - Mission Bay- Site Number : 8400005

San Francisco, California, United States

University of Colorado Hospital- Site Number : 8400026

Aurora, Colorado, United States

Yale University School of Medicine- Site Number : 8400025

New Haven, Connecticut, United States

University of Florida Health- Site Number : 8400035

Gainesville, Florida, United States

Nemours Children's Speciality Care- Jacksonville- Site Number : 8400006

Jacksonville, Florida, United States

University of South Florida- Site Number : 8400022

Tampa, Florida, United States

Midtown Medical Center - Columbus- Site Number : 8400013

Columbus, Georgia, United States

University of Chicago Medical Center- Site Number : 8400017

Chicago, Illinois, United States

Indiana University Health Riley Hospital for Children- Site Number : 8400004

Indianapolis, Indiana, United States

Norton Brownsboro Hospital- Site Number : 8400030

Louisville, Kentucky, United States

Johns Hopkins School of Medicine- Site Number : 8400031

Baltimore, Maryland, United States

University of Michigan Health System - Ann Arbor- Site Number : 8400028

Ann Arbor, Michigan, United States

Associated Endocrinologists, PC- Site Number : 8400039

Farmington Hills, Michigan, United States

Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400009

Grand Rapids, Michigan, United States

Mayo Clinic- Site Number : 8400010

Rochester, Minnesota, United States

Children's Mercy Adelle Hall Campus- Site Number : 8400014

Kansas City, Missouri, United States

Women & Children's Hospital of Buffalo- Site Number : 8400018

Buffalo, New York, United States

Feinstein Institute for Medical Research (Northwell)- Site Number : 8400016

Manhasset, New York, United States

Ten's Medical PC- Site Number : 8400027

Staten Island, New York, United States

SUNY Upstate Medical University - Syracuse- Site Number : 8400007

Syracuse, New York, United States

UNC Children's Hospital- Site Number : 8400008

Chapel Hill, North Carolina, United States

Cincinnati Children's Hospital Medical Center- Site Number : 8400024

Cincinnati, Ohio, United States

Rainbow Babies And Children's Hospital- Site Number : 8400011

Cleveland, Ohio, United States

The Ohio State University- Site Number : 8400032

Columbus, Ohio, United States

Hospital of The University of Pennsylvania- Site Number : 8400021

Philadelphia, Pennsylvania, United States

The Children's Hospital of Philadelphia- Site Number : 8400029

Philadelphia, Pennsylvania, United States

AM Diabetes & Endocrinology Center- Site Number : 8400012

Bartlett, Tennessee, United States

Vanderbilt University Medical Center- Site Number : 8400023

Nashville, Tennessee, United States

Texas Diabetes & Endocrinology - Austin - North Mopac Expressway- Site Number : 8400040

Austin, Texas, United States

University of Texas - Southwestern Medical Center- Site Number : 8400003

Dallas, Texas, United States

Texas Children's Hospital- Site Number : 8400002

Houston, Texas, United States

University of Utah Health Hospital- Site Number : 8400019

Salt Lake City, Utah, United States

United BioSource Corporation- Site Number : 8400001

Morgantown, West Virginia, United States