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Recruiting No phase listed Observational

Registry for Stage 2 Type 1 Diabetes

ClinicalTrials.gov ID: NCT06481904

Public ClinicalTrials.gov record NCT06481904. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 12:31 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06481904
Recruitment status
Recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
Sanofi
Industry
Enrollment
200 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 26, 2024
Primary completion
Jan 14, 2037
Completion
Jan 14, 2037
Last update posted
Apr 12, 2026

2024 – 2037

United States locations

U.S. sites
37
U.S. states
20
U.S. cities
35
Facility City State ZIP Site status
University of California Los Angeles Health- Site Number : 8400020 Los Angeles California 90095 Recruiting
University of California San Francisco - Mission Bay- Site Number : 8400005 San Francisco California 94158 Recruiting
University of Colorado Hospital- Site Number : 8400026 Aurora Colorado 80045 Recruiting
Yale University School of Medicine- Site Number : 8400025 New Haven Connecticut 06510 Recruiting
University of Florida Health- Site Number : 8400035 Gainesville Florida 32610 Recruiting
Nemours Children's Speciality Care- Jacksonville- Site Number : 8400006 Jacksonville Florida 32207 Recruiting
University of Miami Miller School of Medicine- Site Number : 8400037 Miami Florida 33136 Recruiting
Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400034 Miami Florida 33155 Recruiting
University of South Florida- Site Number : 8400022 Tampa Florida 33612 Recruiting
Midtown Medical Center - Columbus- Site Number : 8400013 Columbus Georgia 31901 Recruiting
University of Chicago Medical Center- Site Number : 8400017 Chicago Illinois 60637 Recruiting
Indiana University Health Riley Hospital for Children- Site Number : 8400004 Indianapolis Indiana 46202 Recruiting
Norton Brownsboro Hospital- Site Number : 8400030 Louisville Kentucky 40241 Recruiting
Johns Hopkins School of Medicine- Site Number : 8400031 Baltimore Maryland 21205 Recruiting
University of Michigan Health System - Ann Arbor- Site Number : 8400028 Ann Arbor Michigan 48109 Recruiting
Associated Endocrinologists, PC- Site Number : 8400039 Farmington Hills Michigan 48334 Recruiting
Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400009 Grand Rapids Michigan 49503 Recruiting
Mayo Clinic- Site Number : 8400010 Rochester Minnesota 55902 Recruiting
Children's Mercy Adelle Hall Campus- Site Number : 8400014 Kansas City Missouri 64108 Recruiting
Women & Children's Hospital of Buffalo- Site Number : 8400018 Buffalo New York 14222 Recruiting
Feinstein Institute for Medical Research (Northwell)- Site Number : 8400016 Manhasset New York 11030 Recruiting
Ten's Medical PC- Site Number : 8400027 Staten Island New York 10306 Recruiting
SUNY Upstate Medical University - Syracuse- Site Number : 8400007 Syracuse New York 13210 Recruiting
UNC Children's Hospital- Site Number : 8400008 Chapel Hill North Carolina 27514 Recruiting
Cincinnati Children's Hospital Medical Center- Site Number : 8400024 Cincinnati Ohio 45229 Recruiting
Rainbow Babies And Children's Hospital- Site Number : 8400011 Cleveland Ohio 44106 Recruiting
The Ohio State University- Site Number : 8400032 Columbus Ohio 43210 Recruiting
Hospital of The University of Pennsylvania- Site Number : 8400021 Philadelphia Pennsylvania 19104 Recruiting
The Children's Hospital of Philadelphia- Site Number : 8400029 Philadelphia Pennsylvania 19104 Recruiting
AM Diabetes & Endocrinology Center- Site Number : 8400012 Bartlett Tennessee 38133 Recruiting
Vanderbilt University Medical Center- Site Number : 8400023 Nashville Tennessee 37232 Recruiting
Texas Diabetes & Endocrinology - Austin - North Mopac Expressway- Site Number : 8400040 Austin Texas 78731 Recruiting
University of Texas - Southwestern Medical Center- Site Number : 8400003 Dallas Texas 75390 Recruiting
Cook Children's- Site Number : 8400038 Fort Worth Texas 76104 Recruiting
Texas Children's Hospital- Site Number : 8400002 Houston Texas 77030 Recruiting
University of Utah Health Hospital- Site Number : 8400019 Salt Lake City Utah 84132 Recruiting
United BioSource Corporation- Site Number : 8400001 Morgantown West Virginia 26505 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06481904, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 12, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06481904 live on ClinicalTrials.gov.

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