NCT06481904Recruiting
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
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 26 Jun 2024
- Start date
- 27 Sept 2024
- Primary completion date
- 15 Jan 2037
- Lead sponsor
- Sanofi
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT06481904
What you commit to
- Study type: Observational
- Planned participants: 200
- From 27 Sept 2024 to the primary completion date, 15 Jan 2037
- 37 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (37)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Health System - Ann Arbor- Site Number : 8400028 Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| University of Colorado Hospital- Site Number : 8400026 Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Texas Diabetes & Endocrinology - Austin - North Mopac Expressway- Site Number : 8400040 Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Johns Hopkins School of Medicine- Site Number : 8400031 Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| AM Diabetes & Endocrinology Center- Site Number : 8400012 Coordinator of this site? Confirm its status | Bartlett | United States | Recruiting |
| Women & Children's Hospital of Buffalo- Site Number : 8400018 Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| UNC Children's Hospital- Site Number : 8400008 Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| University of Chicago Medical Center- Site Number : 8400017 Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Cincinnati Children's Hospital Medical Center- Site Number : 8400024 Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Rainbow Babies And Children's Hospital- Site Number : 8400011 Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Midtown Medical Center - Columbus- Site Number : 8400013 Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| The Ohio State University- Site Number : 8400032 Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| University of Texas - Southwestern Medical Center- Site Number : 8400003 Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Farmington Hills | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| University of Florida Health- Site Number : 8400035 Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400009 Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| Texas Children's Hospital- Site Number : 8400002 Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Indiana University Health Riley Hospital for Children- Site Number : 8400004 Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Nemours Children's Speciality Care- Jacksonville- Site Number : 8400006 Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Children's Mercy Adelle Hall Campus- Site Number : 8400014 Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| University of California Los Angeles Health- Site Number : 8400020 Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Norton Brownsboro Hospital- Site Number : 8400030 Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Feinstein Institute for Medical Research (Northwell)- Site Number : 8400016 Coordinator of this site? Confirm its status | Manhasset | United States | Recruiting |
| Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400034 Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| University of Miami Miller School of Medicine- Site Number : 8400037 Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Morgantown | United States | Recruiting |
| Vanderbilt University Medical Center- Site Number : 8400023 Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Yale University School of Medicine- Site Number : 8400025 Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| The Children's Hospital of Philadelphia- Site Number : 8400029 Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Hospital of The University of Pennsylvania- Site Number : 8400021 Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Mayo Clinic- Site Number : 8400010 Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| University of Utah Health Hospital- Site Number : 8400019 Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| University of California San Francisco - Mission Bay- Site Number : 8400005 Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Ten's Medical PC- Site Number : 8400027 Coordinator of this site? Confirm its status | Staten Island | United States | Recruiting |
| SUNY Upstate Medical University - Syracuse- Site Number : 8400007 Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| University of South Florida- Site Number : 8400022 Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.