At a glance
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A 52-Week, Open-Label, Multicenter Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination With Monotherapy of Oral Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus
In Brief
A Phase 3 clinical trial evaluating Albiglutide, Sulfonylurea, and 4 other interventions for Diabetes Mellitus. Completed, enrolled 374 participants across 49 sites.
Detailed Summary
This study is designed to examine the long term safety and efficacy of weekly subcutaneously injected albiglutide in combination with a single oral antidiabetic drug for 52 weeks in Japanese subjects with type 2 diabetes mellitus.
Study Details
Timeline
Interventions
Albiglutide is a fixed-dose, fully disposable pen injector system for delivery of albiglutide from a prefilled dual chamber glass cartridge that is an integral part of the pen. It is intended for single use by the subject. It is designed for manual reconstitution of the dose, priming, and insertion of the pen needle, and manual injection by the subject. The subject will inject albiglutide 30 mg weekly for 52 weeks (with optional uptitration to 50 mg weekly) subcutaneously into the abdomen, alternating between left and right sides. The pen is designed to work with standard pen needles.
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.