A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes
Phase 3
723
about 3.4 years
1–25
27 sites in AZ, CA, CO +14
About this study
Researchers are testing teplizumab compared with placebo in people with recently diagnosed stage 3 type 1 diabetes (T1D) aged 1 to 25 years. The trial will last for 1224 days and measure changes in glycemic control and prandial insulin independency over 52 weeks.
Based on ClinicalTrials.gov records.
What participants do
- 1.Placebo
- 2.Take Teplizumab
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
teplizumab
Primary: For EU countries: Change from baseline in mean 2 hours mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from Area Under the Curve (AUC) in participants 5 years and older, For EU countries: HbA1c change from baseline, For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline
Secondary: Change from baseline in Time-in-Range (TIR) (70-180 mg/dL blood glucose) assessed by continuous glucose monitoring (CGM), Change from baseline in mean 2 hours MMTT stimulated C-peptide concentration, calculated from AUC, Incidence of participants with HbA1c ≤6.5% and requiring ≤0.25 IU/kg/day of insulin, Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and TEAEs leading to treatment discontinuation, Teplizumab PK parameters: Area under the curve [AUC] and [AUClast], Teplizumab PK parameters: Maximum concentration of teplizumab [Cmax]
Endocrinology