70-OR: PROTECT Per-Protocol Analysis—Preserving ß-Cell Function in Children and Adolescents with Newly Diagnosed Stage 3 Type 1 Diabetes (T1D)

70-OR: PROTECT Per-Protocol Analysis—Preserving ß-Cell Function in Children and Adolescents with Newly Diagnosed Stage 3 Type 1 Diabetes (T1D)

Background & Aims: Teplizumab is an anti-CD3 mAb approved for delaying onset of Stage 3 T1D in people ≥8 years old with Stage 2 T1D. In the PROTECT study intent-to-treat (ITT) population, teplizumab demonstrated significantly greater β‑cell function preservation vs placebo (PBO; least-squares me...

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Veröffentlicht in:Diabetes (New York, N.Y.) N.Y.), 2024-06, Vol.73 (Supplement_1), p.1
Hauptverfasser: HEROLD, KEVAN C., DAYAN, COLIN, CHATENOUD, LUCIENNE, GITELMAN, STEPHEN E., SUMNIK, ZDENEK, SIMMONS, KIMBER M., SZYPOWSKA, AGNIESZKA, KNECHT, LAURA, NIEMOELLER, ELISABETH, TIAN, WEI, RAMOS, ELEANOR L.
Format: Artikel
Sprache:eng
Schlagworte:
Beta cells
CD3 antigen
Diabetes
Diabetes mellitus (insulin dependent)
Insulin
Monoclonal antibodies
Population studies
Preservation
Teenagers
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Zusammenfassung:Background & Aims: Teplizumab is an anti-CD3 mAb approved for delaying onset of Stage 3 T1D in people ≥8 years old with Stage 2 T1D. In the PROTECT study intent-to-treat (ITT) population, teplizumab demonstrated significantly greater β‑cell function preservation vs placebo (PBO; least-squares mean difference of C-peptide ln(AUC+1) change from baseline to Week 78 between teplizumab and PBO was 0.13 pmol/mL; p
ISSN:0012-1797
1939-327X
DOI:10.2337/db24-70-OR