Curing Diabetes
Prevention
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
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: RECRUITING*
Study Type: Observational
Population: Patients in the US diagnosed with Stage 2 Type 1 Diabetes
Intervention: This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Comparison: Patients not planned to be treated
Outcome: Number of adverse events of special interests (AESI); Number of serious adverse events (SAE); Number of adverse events (AE) in mothers, fetuses, and infants exposed to TZIELD during pregnancy; Number of maternal pregnancy-related events; Developmental outcomes of the infant.
Timing: 10 years
Additional information and inclusion criteria:
https://clinicaltrials.gov/study/NCT06481904
Contact:
Call 800-633-1610 ext 6 or email Contact-US@sanofi.com
Call 305-243-4485 or email cblaschke@miami.edu
Sponsor: Sanofi
Principal Investigator: Janine Sanchez, University of Miami
*Status as of June 9, 2026, on https://clinicaltrials.gov.