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NCT06481904Recruiting

Registry for Stage 2 Type 1 Diabetes

Sanofi

Start Date

9/27/2024

Completion Date

1/15/2037

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.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: TZIELD-Exposed Cohort * Patients in the US diagnosed with Stage 2 T1D who are planned to initiate TZIELD treatment according to the currently approved label or who have initiated TZIELD treatment within 6 months prior to enrollment: * Day 1: 65 mcg/m2 * Day 2: 125 mcg/m2 * Day 3: 250 mcg/m2 * Day 4: 500 mcg/m2 * Days 5 through 14: 1,030 mcg/m2 per day * Cumulative dose is approximately 11,240 mcg/m2 * Appropriate written informed consent/assent as applicable for the age of the patient TZIELD-Unexposed Cohort * Patients in the US diagnosed with Stage 2 T1D but who are not treated with TZIELD * Appropriate written informed consent/assent as applicable for the age of the patient Exclusion Criteria: * Patients who initiated TZIELD treatment more than 6 months prior to enrollment * Patients who had participated in a previous clinical trial for TZIELD * Patients in an ongoing clinical trial of an investigational product or who had ended participation within 6 months prior to study enrollment; patients participating in other observational studies may be enrolled The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Interventions

DRUG

TZIELD (teplizumab-mzwv)

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Conditions

Type 1 Diabetes

Locations

University of California Los Angeles Health- Site Number : 8400020

Los Angeles, California 90095

United States

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

San Francisco, California 94158

United States

University of Colorado Hospital- Site Number : 8400026

Aurora, Colorado 80045

United States

Yale University School of Medicine- Site Number : 8400025

New Haven, Connecticut 06510

United States

University of Florida Health- Site Number : 8400035

Gainesville, Florida 32610

United States

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

Jacksonville, Florida 32207

United States

University of Miami Miller School of Medicine- Site Number : 8400037

Miami, Florida 33136

United States

Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400034

Miami, Florida 33155

United States

University of South Florida- Site Number : 8400022

Tampa, Florida 33612

United States

Midtown Medical Center - Columbus- Site Number : 8400013

Columbus, Georgia 31901

United States

University of Chicago Medical Center- Site Number : 8400017

Chicago, Illinois 60637

United States

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

Indianapolis, Indiana 46202

United States

Norton Brownsboro Hospital- Site Number : 8400030

Louisville, Kentucky 40241

United States

Johns Hopkins School of Medicine- Site Number : 8400031

Baltimore, Maryland 21205

United States

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

Ann Arbor, Michigan 48109

United States

Associated Endocrinologists, PC- Site Number : 8400039

Farmington Hills, Michigan 48334

United States

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

Grand Rapids, Michigan 49503

United States

Mayo Clinic- Site Number : 8400010

Rochester, Minnesota 55902

United States

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

Kansas City, Missouri 64108

United States

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

Buffalo, New York 14222

United States

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

Manhasset, New York 11030

United States

Ten's Medical PC- Site Number : 8400027

Staten Island, New York 10306

United States

SUNY Upstate Medical University - Syracuse- Site Number : 8400007

Syracuse, New York 13210

United States

UNC Children's Hospital- Site Number : 8400008

Chapel Hill, North Carolina 27514

United States

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

Cincinnati, Ohio 45229

United States

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

Cleveland, Ohio 44106

United States

The Ohio State University- Site Number : 8400032

Columbus, Ohio 43210

United States

Hospital of The University of Pennsylvania- Site Number : 8400021

Philadelphia, Pennsylvania 19104

United States

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

Philadelphia, Pennsylvania 19104

United States

AM Diabetes & Endocrinology Center- Site Number : 8400012

Bartlett, Tennessee 38133

United States

Vanderbilt University Medical Center- Site Number : 8400023

Nashville, Tennessee 37232

United States

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

Austin, Texas 78731

United States

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

Dallas, Texas 75390

United States

Cook Children's- Site Number : 8400038

Fort Worth, Texas 76104

United States

Texas Children's Hospital- Site Number : 8400002

Houston, Texas 77030

United States

University of Utah Health Hospital- Site Number : 8400019

Salt Lake City, Utah 84132

United States

United BioSource Corporation- Site Number : 8400001

Morgantown, West Virginia 26505

United States