Study Evaluating 14-Day Intravenous Teplizumab Infusion in Japanese Children and Adults Aged 1 to 34 with Stage 2 Type 1 Diabetes

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a 14-day intravenous infusion of teplizumab in Japanese children and adults aged 1 to 34 years who have Stage 2 Type 1 Diabetes T1D. This Phase 2, parallel study aims to confirm the effects of teplizumab on delaying progression to Stage 3 T1D, building on prior studies conducted in Western countries. The study also assesses pharmacokinetics, pharmacodynamics, and immunogenicity of this treatment regimen. Participants are randomly assigned to receive either teplizumab via intravenous infusion for 14 days or no treatment as a control. The dosing regimen matches the FDA-approved schedule for delaying Stage 3 T1D onset in patients aged 8 years and older. The study duration is about 756 days, during which participants are monitored for clinical outcomes and safety. During the study, participants undergo regular assessments including blood tests for C-peptide, insulin, glucose tolerance, and hemoglobin A1c, as well as monitoring for adverse events and vital signs. The primary outcomes include the number of participants progressing to Stage 3 T1D within 104 weeks and changes in insulin production measures. Safety is monitored throughout the study period with laboratory tests, electrocardiograms, and recording any treatment-emergent adverse events.

Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes