NCT06892002

Description of Patients With Type 1 Diabetes Treated With Teplizumab

A Real-World Observational Study Characterizing Patients With Type 1 Diabetes Treated With Teplizumab

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease caused by the destruction of pancreatic β cells. T1D pathogenesis progresses through several stages: Stage 1 T1D includes the presence of β cell autoimmunity and thus presence of islet autoantibodies, without the presence of dysglycemia and symptoms. Stage 2 T1D includes the presence of islet autoantibodies and dysglycemia, also with no symptoms. Stage 3 T1D includes presence of islet autoantibodies, overt hyperglycemia, and symptoms; most patients with Stage 3 T1D meet standard diagnostic criteria for diabetes and require insulin treatment. Teplizumab has been shown to delay progression to Stage 3 in participants at Stage 2 in a Phase 2 clinical trial, leading to subsequent approval in the United States of America (USA). Patients outside of the USA are able to receive the treatment through Pre-Registration Import Licenses and Managed Access Programs. The current study will collect data on the use of teplizumab in routine care, to better understand which patients received teplizumab and how these patients were managed after they received the treatment.

Conditions

• Type 1 Diabetes

Interventions

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

Timeline

• Start date: 2025-02-11
• Primary completion: 2025-08-05
• Completion: 2025-08-05
• First posted: 2025-03-24
• Last updated: 2025-08-15

Locations

27 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated drug study