title: An adaptive, dose-finding, seamless phase 2/3 study of a long-acting glucagon-like peptide-1 analog (dulaglutide): trial design and baseline characteristics.
abstract: Dulaglutide (dula, LY2189265) is a once-weekly glucagon-like peptide-1 analog in development for the treatment of type 2 diabetes mellitus. An adaptive, dose-finding, inferentially seamless phase 2/3 study was designed to support the development of this novel diabetes therapeutic. The study is divided into two stages based on two randomization schemes: a Bayesian adaptive scheme (stage 1) and a fixed scheme (stage 2). Stage 1 of the trial employs an adaptive, dose-finding design to lead to a dula dose-selection decision or early study termination due to futility. If dose selection occurs, the study proceeds to stage 2 to allow continued evaluation of the selected dula doses. At completion, the entire study will serve as a confirmatory phase 3 trial. The final study design is discussed, along with specifics pertaining to the actual execution of this study and selected baseline characteristics of the participants.
authors.affiliation: Lilly Diabetes, Eli Lilly and Company, Indianapolis, IN 46285, USA. geigerma@lilly.com
authors.forename: Mary Jane
authors.initials: MJ
authors.lastname: Geiger
authors.forename: Zachary
authors.initials: Z
authors.lastname: Skrivanek
authors.forename: Brenda
authors.initials: B
authors.lastname: Gaydos
authors.forename: Jenny
authors.initials: J
authors.lastname: Chien
authors.forename: Scott
authors.initials: S
authors.lastname: Berry
authors.forename: Donald
authors.initials: D
authors.lastname: Berry
mesh_terms: D001499:Bayes Theorem; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D052216:Glucagon-Like Peptide 1 / Q000031:analogs & derivatives; D004763:Glucagon-Like Peptides / Q000031:analogs & derivatives; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007141:Immunoglobulin Fc Fragments / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011719:Pyrazines / Q000008:administration & dosage; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage*; D012107:Research Design; D000068900:Sitagliptin Phosphate; D014230:Triazoles / Q000008:administration & dosage
chemical_list: D007004:Hypoglycemic Agents; D007141:Immunoglobulin Fc Fragments; D011719:Pyrazines; D011993:Recombinant Fusion Proteins; D014230:Triazoles; D004763:Glucagon-Like Peptides; D052216:Glucagon-Like Peptide 1; D000068900:Sitagliptin Phosphate; C555680:dulaglutide