MedPath

Registry for Stage 2 Type 1 Diabetes

Recruiting
Conditions
Type 1 Diabetes
Interventions
Registration Number
NCT06481904
Lead Sponsor
Sanofi
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
200
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
TZIELD groupTZIELD (teplizumab-mzwv)Patients prior to the initiation of TZIELD treatment or initiated TZIELD treatment within 6 months to study enrollment
Primary Outcome Measures
NameTimeMethod
Number of adverse events of special interests (AESI)Throughout the study, approximately 10 years

Presence of AESIs including cytokine release syndrome (CRS), serious infections, hypersensitivity reactions, lymphoproliferative disorders, and malignancies

Number of adverse events (AE) in mothers, fetuses, and infants exposed to TZIELD during pregnancyFrom start of pregnancy to 12 months post-partum
Developmental outcomes of the infantFrom birth of infant to 12 months
Number of serious adverse events (SAE)Throughout the study, approximately 10 years
Number of maternal pregnancy-related eventsFrom start of pregnancy to 12 months post-partum
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (25)

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

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San Francisco, California, United States

Yale University School of Medicine- Site Number : 8400025

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New Haven, Connecticut, United States

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

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Cleveland, Ohio, United States

University of Chicago Medical Center- Site Number : 8400017

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Chicago, Illinois, United States

Riley Hospital for Children at IU Health- Site Number : 8400004

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Indianapolis, Indiana, United States

Norton Healthcare- Site Number : 8400030

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Louisville, Kentucky, United States

Johns Hopkins School of Medicine- Site Number : 8400031

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Baltimore, Maryland, United States

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

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Ann Arbor, Michigan, United States

Corewell Health- Site Number : 8400009

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Grand Rapids, Michigan, United States

Mayo Clinic- Site Number : 8400010

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Rochester, Minnesota, United States

Scroll for more (15 remaining)
University of California San Francisco - Mission Bay- Site Number : 8400005
🇺🇸San Francisco, California, United States

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