Registry for Stage 2 Type 1 Diabetes
An Observational, Long-term Safety Study of TZIELD® (Teplizumab-mzwv) in Patients With Stage 2 Type 1 Diabetes
2 other identifiers
observational
200
1 country
37
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2024
Longer than P75 for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2024
CompletedFirst Posted
Study publicly available on registry
July 1, 2024
CompletedStudy Start
First participant enrolled
September 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2037
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 15, 2037
April 13, 2026
April 1, 2026
12.3 years
June 26, 2024
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Number of adverse events of special interests (AESI)
Presence of AESIs including cytokine release syndrome (CRS), serious infections, hypersensitivity reactions, lymphoproliferative disorders, and malignancies
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
Number of maternal pregnancy-related events
From start of pregnancy to 12 months post-partum
Developmental outcomes of the infant
From birth of infant to 12 months
Study Arms (2)
TZIELD group
Patients prior to the initiation of TZIELD treatment or initiated TZIELD treatment within 6 months to study enrollment
Comparator group
Patients not planned to be treated
Interventions
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Eligibility Criteria
Patients in the US diagnosed with Stage 2 Type 1 Diabetes
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (37)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Central Study Contacts
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2024
First Posted
July 1, 2024
Study Start
September 27, 2024
Primary Completion (Estimated)
January 15, 2037
Study Completion (Estimated)
January 15, 2037
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org