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Registry for Stage 2 Type 1 Diabetes

NCT06481904 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-04-13

No results posted yet for this study

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

Interventions

DRUG

TZIELD (teplizumab-mzwv)

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-27
Primary Completion
2037-01-15
Completion
2037-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06481904 on ClinicalTrials.gov