drugset / Trial / NCT02229240
Albiglutide Versus Placebo Added-on to Basal-Bolus Insulin Therapy in Subjects With Type 2 Diabetes Mellitus
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | albiglutide | Peptide | 50 mg | Subcutaneous |