Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus
Status:
Completed
Trial end date:
2017-05-15
Target enrollment:
Participant gender:
Summary
This is a phase III, randomized, double-blind, multicenter, parallel group, repeat-dose,
study of 26 weeks duration to evaluate the efficacy, safety, tolerability and pharmacodynamic
response of albiglutide liquid drug product relative to the commercial lyophilized drug
product. The study will specifically evaluate the potential for immunogenicity (example
[e.g.] incidences of anti-drug antibodies [ADA]) and injection site reactions (ISRs).
Albiglutide is a novel analogue of glucagon-like peptide-1 (GLP-1) with a sufficiently long
half-life to permit once a week injection. Currently, lyophilized albiglutide and the diluent
are provided in a dual chamber cartridge (DCC), single-dose pen injector, requiring
reconstitution prior to use. A liquid formulation of albiglutide will enable the
commercialization of a liquid product in a single dose, ready-to-use prefilled syringe in an
auto-injector.
The primary hypothesis of this study is to test that liquid drug product will provide
glycemic control (as measured by HbA1c change from baseline) non-inferior to lyophilized drug
product for a period of 26 weeks of treatment in subjects with T2DM.
This study will comprise of 3 study periods : screening (2 weeks), treatment (26 weeks) and
for those subjects not entering the extension study a follow-up period (8 weeks).
Approximately 300 subjects will be randomized in a 1:1 ratio to either Albiglutide active
liquid auto-injector (LAI) plus Placebo lyophilized DCC pen injector (lyophilized DCC PI);
or, Albiglutide lyophilized DCC PI plus Placebo LAI.