Conditions: Diabetes Mellitus
Keywords: albiglutide Japanese glucagon-like peptide-1 GSK716155
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 374
Healthy volunteers: no

Brief 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.

Detailed description:
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. Subjects with a historical diagnosis of type 2 diabetes mellitus who are inadequately controlled on a single oral antidiabetic agent will be recruited into the study. Subjects will continue on their single antidiabetic agent and once weekly albiglutide will be added.

Arms:
arm 1: Albiglutide in combination with background sulfonylurea arm 2: Albiglutide in combination with background biguanide arm 3: Albiglutide in combination with background glinide arm 4: Albiglutide in combination with background thiazolidinedione arm 5: Albiglutide in combination with background alpha-glucosidase inhibitor

Interventions: intervention 1: Albiglutide intervention 2: Sulfonylurea intervention 3: Biguanide intervention 4: Glinide intervention 5: Thiazolidinedione intervention 6: Alpha-glucosidase inhibitor
Intervention descriptions: intervention 1: 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. intervention 2: Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed. intervention 3: Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed. intervention 4: Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed. intervention 5: Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed. intervention 6: Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.

Protocol document: