Albiglutide Versus Placebo Added-on to Basal-Bolus Insulin Therapy in Subjects With Type 2 Diabetes Mellitus
Status:
Withdrawn
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
This Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled, multicenter,
treat-to-target study of 26 weeks treatment duration will evaluate the efficacy and safety of
once-weekly albiglutide versus placebo as add-on to intensified basal-bolus insulin therapy
(with or without metformin) in subjects with Type 2 Diabetes Mellitus (T2DM). Approximately
450 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide
+ intensified basal-bolus insulin therapy (with or without metformin) or placebo +
intensified basal-bolus insulin therapy (with or without metformin. The total duration of a
subject's participation will be approximately 32 weeks.
Phase:
Phase 3
Details
Lead Sponsor:
GlaxoSmithKline
Collaborator:
PPD
Treatments:
Glucagon-Like Peptide 1 Insulin Insulin, Globin Zinc rGLP-1 protein