Ignite Creation Date:
2024-05-06 @ 8:09 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02683746
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2016-01-28
Brief Title:
Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Repeat-dose Study in Subjects With Type 2 Diabetes Mellitus to Assess the Efficacy Safety Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg 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 11 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
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 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None