An adaptive, dose-finding, seamless phase 2/3 study of a long-acting glucagon-like peptide-1 analog (dulaglutide): Trial design and baseline characteristics

Journal of Diabetes Science and Technology

Volumn 6, Issue 6, 2012, Pages 1319-1327

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

^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; Inferentially seamless

Indexed keywords

DULAGLUTIDE; METFORMIN; PLACEBO; SITAGLIPTIN; ANTIDIABETIC AGENT; DRUG DERIVATIVE; GLUCAGON LIKE PEPTIDE 1; HYBRID PROTEIN; IMMUNOGLOBULIN FC FRAGMENT; PYRAZINE DERIVATIVE; TRIAZOLE DERIVATIVE;

ADULT; AGED; CONFERENCE PAPER; CONTROLLED STUDY; DOSE CALCULATION; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG MEGADOSE; FEMALE; HUMAN; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; STUDY DESIGN; YOUNG ADULT; ARTICLE; BAYES THEOREM; CONTROLLED CLINICAL TRIAL; DOSE RESPONSE; METHODOLOGY;

BAYES THEOREM; DIABETES MELLITUS, TYPE 2; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; GLUCAGON-LIKE PEPTIDE 1; HUMANS; HYPOGLYCEMIC AGENTS; IMMUNOGLOBULIN FC FRAGMENTS; MALE; MIDDLE AGED; PYRAZINES; RECOMBINANT FUSION PROTEINS; RESEARCH DESIGN; TRIAZOLES;

EID: 84882997236     PISSN: None     EISSN: 19322968     Source Type: Journal    
DOI: 10.1177/193229681200600610     Document Type: Conference Paper

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