Conditions: Diabetes Mellitus, Type 2
Keywords: sitagliptin albiglutide renal impairment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 507
Healthy volunteers: no

Brief summary:
This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

Detailed description:
This randomized, double-blind, active-controlled, 2 parallel-group, multicenter study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

Arms:
arm 1: albiglutide weekly subcutaneous injection + sitagliptin matching placebo arm 2: albiglutide matching placebo + sitagliptin

Interventions: intervention 1: albiglutide intervention 2: sitagliptin
Intervention descriptions: intervention 1: albiglutide weekly subcutaneous injection + sitagliptin matching placebo intervention 2: albiglutide matching placebo + sitagliptin (25mg, 50mg or 100mg depending on level of renal impairment)

Protocol document: