Registry for Stage 2 Type 1 Diabetes

April 10, 2026 updated by: Sanofi

An Observational, Long-term Safety Study of TZIELD® (Teplizumab-mzwv) in Patients With Stage 2 Type 1 Diabetes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles Health- Site Number : 8400020
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco - Mission Bay- Site Number : 8400005
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital- Site Number : 8400026
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University School of Medicine- Site Number : 8400025
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida Health- Site Number : 8400035
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Nemours Children's Speciality Care- Jacksonville- Site Number : 8400006
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine- Site Number : 8400037
      • Miami, Florida, United States, 33155
        • Recruiting
        • Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400034
      • Tampa, Florida, United States, 33612
        • Recruiting
        • University of South Florida- Site Number : 8400022
    • Georgia
      • Columbus, Georgia, United States, 31901
        • Recruiting
        • Midtown Medical Center - Columbus- Site Number : 8400013
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center- Site Number : 8400017
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health Riley Hospital for Children- Site Number : 8400004
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Recruiting
        • Norton Brownsboro Hospital- Site Number : 8400030
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins School of Medicine- Site Number : 8400031
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Health System - Ann Arbor- Site Number : 8400028
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Associated Endocrinologists, PC- Site Number : 8400039
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400009
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Recruiting
        • Mayo Clinic- Site Number : 8400010
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Adelle Hall Campus- Site Number : 8400014
    • New York
      • Buffalo, New York, United States, 14222
        • Recruiting
        • Women & Children's Hospital of Buffalo- Site Number : 8400018
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Feinstein Institute for Medical Research (Northwell)- Site Number : 8400016
      • Staten Island, New York, United States, 10306
        • Recruiting
        • Ten's Medical PC- Site Number : 8400027
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical University - Syracuse- Site Number : 8400007
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • UNC Children's Hospital- Site Number : 8400008
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center- Site Number : 8400024
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Rainbow Babies And Children's Hospital- Site Number : 8400011
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University- Site Number : 8400032
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of The University of Pennsylvania- Site Number : 8400021
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • The Children's Hospital of Philadelphia- Site Number : 8400029
    • Tennessee
      • Bartlett, Tennessee, United States, 38133
        • Recruiting
        • AM Diabetes & Endocrinology Center- Site Number : 8400012
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center- Site Number : 8400023
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Texas Diabetes & Endocrinology - Austin - North Mopac Expressway- Site Number : 8400040
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas - Southwestern Medical Center- Site Number : 8400003
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Cook Children's- Site Number : 8400038
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital- Site Number : 8400002
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah Health Hospital- Site Number : 8400019
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Recruiting
        • United BioSource Corporation- Site Number : 8400001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients in the US diagnosed with Stage 2 Type 1 Diabetes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TZIELD group
Patients prior to the initiation of TZIELD treatment or initiated TZIELD treatment within 6 months to study enrollment
Drug: TZIELD (teplizumab-mzwv)
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Comparator group
Patients not planned to be treated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events of special interests (AESI)
Time Frame: Throughout the study, approximately 10 years
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)
Time Frame: Throughout the study, approximately 10 years
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
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
From start of pregnancy to 12 months post-partum
Developmental outcomes of the infant
Time Frame: From birth of infant to 12 months
From birth of infant to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2024

Primary Completion (Estimated)

January 15, 2037

Study Completion (Estimated)

January 15, 2037

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBS18117
  • U1111-1306-6690 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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