drugset / Trial / NCT02229240

Albiglutide Versus Placebo Added-on to Basal-Bolus Insulin Therapy in Subjects With Type 2 Diabetes Mellitus

NCT02229240

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2015-08
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject albiglutide Peptide 50 mg Subcutaneous