Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

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.
    


Intervention name(s): Lyophilized albiglutide DCC pen injector; Lyophilized albiglutide DCC pen injector matching placebo; Albiglutide liquid auto-injector; Albiglutide liquid auto-injector matching placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A fixed-dose, fully disposable pen injector system with a prefilled dual chamber glass cartridge (DCC) containing lyophilized albiglutide (30mg or 50mg) delivering an injection volume of 0.5mL.; A fixed-dose, fully disposable pen injector system with a prefilled DCC containing matching placebo delivering an injection volume of 0.5mL; A fixed-dose, single use, disposable auto-injector containing albiglutide liquid (30mg or 50mg) in a prefilled glass syringe. The auto-injector delivers the albiglutide liquid in an injection volume of 0.6 mL for the 30mg dose and 1.0 mL for the 50mg dose.; A fixed-dose, single use, disposable auto-injector containing matching placebo in a prefilled glass syringe. The auto-injector delivers the matching placebo in an injection volume of 0.6 mL for the 30mg dose and 1.0 mL for the 50mg dose.
Intervention MeSH terms: rGLP-1 protein; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pharmacodynamics; Safety; Albiglutide; Tolerability; Type 2 Diabetes Mellitus; Efficacy