Application of Adaptive Design Methodology in Development of a Long-Acting Glucagon-Like Peptide-1 Analog (Dulaglutide): Statistical Design and Simulations

BACKGROUND: Dulaglutide (dula, LY2189265), a long-acting glucagon-like peptide-1 analog, is being developed to treat type 2 diabetes mellitus. METHODS: To foster the development of dula, we designed a two-stage adaptive, dose-finding, inferentially seamless phase 2/3 study. The Bayesian theoretical...

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Auteurs principaux: Skrivanek, Zachary, Berry, Scott, Berry, Don, Chien, Jenny, Geiger, Mary Jane, Anderson, James H., Gaydos, Brenda
Format: Artigo
Langue:Inglês
Publié: Diabetes Technology Society 2012
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Symposium
Accès en ligne:https://ncbi.nlm.nih.gov/pmc/articles/PMC3570870/
https://ncbi.nlm.nih.gov/pubmed/23294775
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