Recruiting

Observational Study

Sponsor:

Sanofi

Code:

NCT06481904

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

TZIELD (teplizumab-mzwv)

Study Details

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.

Conditions

Type 1 Diabetes

Study ID

NCT06481904

Start date

Sep 27, 2024

Status verified date

Apr, 2026

Completion date

Jan 15, 2037

Anticipated

Primary completion date

Jan 15, 2037

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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

TZIELD (teplizumab-mzwv)

This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Primary outcome measure

  • Number of adverse events of special interests (AESI) [ Time Frame: Throughout the study, approximately 10 years ]
  • Number of serious adverse events (SAE) [ Time Frame: Throughout the study, approximately 10 years ]
  • Number of adverse events (AE) in mothers, fetuses, and infants exposed to TZIELD during pregnancy [ Time Frame: From start of pregnancy to 12 months post-partum ]
  • Number of maternal pregnancy-related events [ Time Frame: From start of pregnancy to 12 months post-partum ]
  • Developmental outcomes of the infant [ Time Frame: From birth of infant to 12 months ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610Contact-US@sanofi.com

Locations

University of California Los Angeles Health- Site Number : 8400020

Recruiting

Los Angeles, California, United States, 90095

University of California San Francisco - Mission Bay- Site Number : 8400005

Recruiting

San Francisco, California, United States, 94158

University of Colorado Hospital- Site Number : 8400026

Recruiting

Aurora, Colorado, United States, 80045

Yale University School of Medicine- Site Number : 8400025

Recruiting

New Haven, Connecticut, United States, 06510

University of Florida Health- Site Number : 8400035

Recruiting

Gainesville, Florida, United States, 32610

Nemours Children's Speciality Care- Jacksonville- Site Number : 8400006

Recruiting

Jacksonville, Florida, United States, 32207

University of Miami Miller School of Medicine- Site Number : 8400037

Recruiting

Miami, Florida, United States, 33136

Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400034

Recruiting

Miami, Florida, United States, 33155

University of South Florida- Site Number : 8400022

Recruiting

Tampa, Florida, United States, 33612

Midtown Medical Center - Columbus- Site Number : 8400013

Recruiting

Columbus, Georgia, United States, 31901

University of Chicago Medical Center- Site Number : 8400017

Recruiting

Chicago, Illinois, United States, 60637

Indiana University Health Riley Hospital for Children- Site Number : 8400004

Recruiting

Indianapolis, Indiana, United States, 46202

Norton Brownsboro Hospital- Site Number : 8400030

Recruiting

Louisville, Kentucky, United States, 40241

Johns Hopkins School of Medicine- Site Number : 8400031

Recruiting

Baltimore, Maryland, United States, 21205

University of Michigan Health System - Ann Arbor- Site Number : 8400028

Recruiting

Ann Arbor, Michigan, United States, 48109

Associated Endocrinologists, PC- Site Number : 8400039

Recruiting

Farmington Hills, Michigan, United States, 48334

Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400009

Recruiting

Grand Rapids, Michigan, United States, 49503

Mayo Clinic- Site Number : 8400010

Recruiting

Rochester, Minnesota, United States, 55902

Children's Mercy Adelle Hall Campus- Site Number : 8400014

Recruiting

Kansas City, Missouri, United States, 64108

Women & Children's Hospital of Buffalo- Site Number : 8400018

Recruiting

Buffalo, New York, United States, 14222

Feinstein Institute for Medical Research (Northwell)- Site Number : 8400016

Recruiting

Manhasset, New York, United States, 11030

Ten's Medical PC- Site Number : 8400027

Recruiting

Staten Island, New York, United States, 10306

SUNY Upstate Medical University - Syracuse- Site Number : 8400007

Recruiting

Syracuse, New York, United States, 13210

UNC Children's Hospital- Site Number : 8400008

Recruiting

Chapel Hill, North Carolina, United States, 27514

Cincinnati Children's Hospital Medical Center- Site Number : 8400024

Recruiting

Cincinnati, Ohio, United States, 45229

Rainbow Babies And Children's Hospital- Site Number : 8400011

Recruiting

Cleveland, Ohio, United States, 44106

The Ohio State University- Site Number : 8400032

Recruiting

Columbus, Ohio, United States, 43210

Hospital of The University of Pennsylvania- Site Number : 8400021

Recruiting

Philadelphia, Pennsylvania, United States, 19104

The Children's Hospital of Philadelphia- Site Number : 8400029

Recruiting

Philadelphia, Pennsylvania, United States, 19104

AM Diabetes & Endocrinology Center- Site Number : 8400012

Recruiting

Bartlett, Tennessee, United States, 38133

Vanderbilt University Medical Center- Site Number : 8400023

Recruiting

Nashville, Tennessee, United States, 37232

Texas Diabetes & Endocrinology - Austin - North Mopac Expressway- Site Number : 8400040

Recruiting

Austin, Texas, United States, 78731

University of Texas - Southwestern Medical Center- Site Number : 8400003

Recruiting

Dallas, Texas, United States, 75390

Cook Children's- Site Number : 8400038

Recruiting

Fort Worth, Texas, United States, 76104

Texas Children's Hospital- Site Number : 8400002

Recruiting

Houston, Texas, United States, 77030

University of Utah Health Hospital- Site Number : 8400019

Recruiting

Salt Lake City, Utah, United States, 84132

United BioSource Corporation- Site Number : 8400001

Recruiting

Morgantown, West Virginia, United States, 26505

More Information

Sponsor

Sanofi

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sanofi on 2026-04-13.