Application of adaptive design methodology in development of a long-acting glucagon-like peptide-1 analog (dulaglutide): Statistical design and simulations

Journal of Diabetes Science and Technology

Volumn 6, Issue 6, 2012, Pages 1305-1318

  Skrivanek, Zachary ^a   Berry, Scott ^b   Berry, Don ^b,c   Chien, Jenny ^a   Geiger, Mary Jane ^a   Anderson Jr , James H ^d   Gaydos, Brenda ^a  

^a ELI LILLY AND COMPANY   (United States)

^b BERRY CONSULTANTS   (United States)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^d Symcopeia Company   (United States)

Author keywords

Adaptive dose finding; Dulaglutide; GLP 1; Seamless design

Indexed keywords

DULAGLUTIDE; GLUCAGON LIKE PEPTIDE 1; HEMOGLOBIN A1C; SITAGLIPTIN; ANTIDIABETIC AGENT; DRUG DERIVATIVE; HYBRID PROTEIN; IMMUNOGLOBULIN FC FRAGMENT;

BAYES THEOREM; CONCEPTUAL FRAMEWORK; CONFERENCE PAPER; CONTROLLED STUDY; DIABETIC PATIENT; DOSE CALCULATION; HUMAN; METHODOLOGY; NON INSULIN DEPENDENT DIABETES MELLITUS; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SIMULATION; STUDY DESIGN; ALGORITHM; ARTICLE; CONTROLLED CLINICAL TRIAL; DOSE RESPONSE; DOUBLE BLIND PROCEDURE;

ALGORITHMS; DIABETES MELLITUS, TYPE 2; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; GLUCAGON-LIKE PEPTIDE 1; HUMANS; HYPOGLYCEMIC AGENTS; IMMUNOGLOBULIN FC FRAGMENTS; RECOMBINANT FUSION PROTEINS; RESEARCH DESIGN;

EID: 84882961810     PISSN: None     EISSN: 19322968     Source Type: Journal    
DOI: 10.1177/193229681200600609     Document Type: Conference Paper

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