Registry for Stage 2 Type 1 Diabetes

Condition(s) studied

Investigational drug(s) / intervention(s)

TZIELD (teplizumab-mzwv): This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

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.

Eligibility

Primary outcome measure(s)

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

Trial sites (37)

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