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
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Placebo
- 2.Take Teplizumab
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
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