NCT06481904

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

• Type 1 Diabetes

Interventions

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

Timeline

• Start date: 2024-09-27
• Primary completion: 2037-01-15
• Completion: 2037-01-15
• First posted: 2024-07-01
• Last updated: 2026-04-13

Locations

37 sites across 1 country: United States

Regulatory

• FDA-regulated drug study