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.
⁃ 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
• 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