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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
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

Full criteria on ClinicalTrials.gov

Sites (37)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan Health System - Ann Arbor- Site Number : 8400028
Coordinator of this site? Confirm its status
Ann ArborUnited StatesRecruiting
University of Colorado Hospital- Site Number : 8400026
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
Texas Diabetes & Endocrinology - Austin - North Mopac Expressway- Site Number : 8400040
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting
Johns Hopkins School of Medicine- Site Number : 8400031
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
AM Diabetes & Endocrinology Center- Site Number : 8400012
Coordinator of this site? Confirm its status
BartlettUnited StatesRecruiting
Women & Children's Hospital of Buffalo- Site Number : 8400018
Coordinator of this site? Confirm its status
BuffaloUnited StatesRecruiting
UNC Children's Hospital- Site Number : 8400008
Coordinator of this site? Confirm its status
Chapel HillUnited StatesRecruiting
University of Chicago Medical Center- Site Number : 8400017
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
Cincinnati Children's Hospital Medical Center- Site Number : 8400024
Coordinator of this site? Confirm its status
CincinnatiUnited StatesRecruiting
Rainbow Babies And Children's Hospital- Site Number : 8400011
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting
Midtown Medical Center - Columbus- Site Number : 8400013
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
The Ohio State University- Site Number : 8400032
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
University of Texas - Southwestern Medical Center- Site Number : 8400003
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
-
Coordinator of this site? Confirm its status
Farmington HillsUnited StatesRecruiting
-
Coordinator of this site? Confirm its status
Fort WorthUnited StatesRecruiting
University of Florida Health- Site Number : 8400035
Coordinator of this site? Confirm its status
GainesvilleUnited StatesRecruiting
Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400009
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesRecruiting
Texas Children's Hospital- Site Number : 8400002
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Indiana University Health Riley Hospital for Children- Site Number : 8400004
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting
Nemours Children's Speciality Care- Jacksonville- Site Number : 8400006
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesRecruiting
Children's Mercy Adelle Hall Campus- Site Number : 8400014
Coordinator of this site? Confirm its status
Kansas CityUnited StatesRecruiting
University of California Los Angeles Health- Site Number : 8400020
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Norton Brownsboro Hospital- Site Number : 8400030
Coordinator of this site? Confirm its status
LouisvilleUnited StatesRecruiting
Feinstein Institute for Medical Research (Northwell)- Site Number : 8400016
Coordinator of this site? Confirm its status
ManhassetUnited StatesRecruiting
Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400034
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
University of Miami Miller School of Medicine- Site Number : 8400037
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
-
Coordinator of this site? Confirm its status
MorgantownUnited StatesRecruiting
Vanderbilt University Medical Center- Site Number : 8400023
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Yale University School of Medicine- Site Number : 8400025
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting
The Children's Hospital of Philadelphia- Site Number : 8400029
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Hospital of The University of Pennsylvania- Site Number : 8400021
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Mayo Clinic- Site Number : 8400010
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting
University of Utah Health Hospital- Site Number : 8400019
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesRecruiting
University of California San Francisco - Mission Bay- Site Number : 8400005
Coordinator of this site? Confirm its status
San FranciscoUnited StatesRecruiting
Ten's Medical PC- Site Number : 8400027
Coordinator of this site? Confirm its status
Staten IslandUnited StatesRecruiting
SUNY Upstate Medical University - Syracuse- Site Number : 8400007
Coordinator of this site? Confirm its status
SyracuseUnited StatesRecruiting
University of South Florida- Site Number : 8400022
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.