In plain English
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Official title
An Observational, Long-term Safety Study of TZIELD® (Teplizumab-mzwv) in Patients With Stage 2 Type 1 Diabetes
About this study
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
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.
Study design
Enrollment target: 200 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2024-09-27
Estimated completion: 2037-01-15
Last updated: 2026-04-13
Interventions
Drug: TZIELD (teplizumab-mzwv)
Primary outcomes
- • Number of adverse events of special interests (AESI) (Throughout the study, approximately 10 years)
- • Number of serious adverse events (SAE) (Throughout the study, approximately 10 years)
- • Number of adverse events (AE) in mothers, fetuses, and infants exposed to TZIELD during pregnancy (From start of pregnancy to 12 months post-partum)
Sponsor
Sanofi · industry
Contacts & investigators
ContactTrial Transparency email recommended (Toll free for US & Canada) · contact · Contact-US@sanofi.com · 800-633-1610
InvestigatorClinical Sciences & Operations · study_director, Sanofi
All locations (37)
University of California Los Angeles Health- Site Number : 8400020Recruiting
Los Angeles, California, United States
University of California San Francisco - Mission Bay- Site Number : 8400005Recruiting
San Francisco, California, United States
University of Colorado Hospital- Site Number : 8400026Recruiting
Aurora, Colorado, United States
Yale University School of Medicine- Site Number : 8400025Recruiting
New Haven, Connecticut, United States
University of Florida Health- Site Number : 8400035Recruiting
Gainesville, Florida, United States
Nemours Children's Speciality Care- Jacksonville- Site Number : 8400006Recruiting
Jacksonville, Florida, United States
University of Miami Miller School of Medicine- Site Number : 8400037Recruiting
Miami, Florida, United States
Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400034Recruiting
Miami, Florida, United States
University of South Florida- Site Number : 8400022Recruiting
Tampa, Florida, United States
Midtown Medical Center - Columbus- Site Number : 8400013Recruiting
Columbus, Georgia, United States
University of Chicago Medical Center- Site Number : 8400017Recruiting
Chicago, Illinois, United States
Indiana University Health Riley Hospital for Children- Site Number : 8400004Recruiting
Indianapolis, Indiana, United States
Norton Brownsboro Hospital- Site Number : 8400030Recruiting
Louisville, Kentucky, United States
Johns Hopkins School of Medicine- Site Number : 8400031Recruiting
Baltimore, Maryland, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400028Recruiting
Ann Arbor, Michigan, United States
Associated Endocrinologists, PC- Site Number : 8400039Recruiting
Farmington Hills, Michigan, United States
Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400009Recruiting
Grand Rapids, Michigan, United States
Mayo Clinic- Site Number : 8400010Recruiting
Rochester, Minnesota, United States
Children's Mercy Adelle Hall Campus- Site Number : 8400014Recruiting
Kansas City, Missouri, United States
Women & Children's Hospital of Buffalo- Site Number : 8400018Recruiting
Buffalo, New York, United States
Feinstein Institute for Medical Research (Northwell)- Site Number : 8400016Recruiting
Manhasset, New York, United States
Ten's Medical PC- Site Number : 8400027Recruiting
Staten Island, New York, United States
SUNY Upstate Medical University - Syracuse- Site Number : 8400007Recruiting
Syracuse, New York, United States
UNC Children's Hospital- Site Number : 8400008Recruiting
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center- Site Number : 8400024Recruiting
Cincinnati, Ohio, United States
Rainbow Babies And Children's Hospital- Site Number : 8400011Recruiting
Cleveland, Ohio, United States
The Ohio State University- Site Number : 8400032Recruiting
Columbus, Ohio, United States
Hospital of The University of Pennsylvania- Site Number : 8400021Recruiting
Philadelphia, Pennsylvania, United States
The Children's Hospital of Philadelphia- Site Number : 8400029Recruiting
Philadelphia, Pennsylvania, United States
AM Diabetes & Endocrinology Center- Site Number : 8400012Recruiting
Bartlett, Tennessee, United States
Vanderbilt University Medical Center- Site Number : 8400023Recruiting
Nashville, Tennessee, United States
Texas Diabetes & Endocrinology - Austin - North Mopac Expressway- Site Number : 8400040Recruiting
Austin, Texas, United States
University of Texas - Southwestern Medical Center- Site Number : 8400003Recruiting
Dallas, Texas, United States
Cook Children's- Site Number : 8400038Recruiting
Fort Worth, Texas, United States
Texas Children's Hospital- Site Number : 8400002Recruiting
Houston, Texas, United States
University of Utah Health Hospital- Site Number : 8400019Recruiting
Salt Lake City, Utah, United States
United BioSource Corporation- Site Number : 8400001Recruiting
Morgantown, West Virginia, United States