A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.

This adaptive design, non-randomized, open-label, staggered parallel group study evaluates the pharmacokinetics and safety of a single subcutaneously injected dose of albiglutide in subjects with type 2 diabetes mellitus with varying degrees of renal function. During Stage 1, a single dose of albiglutide will be administered to subjects with normal renal function and subjects with moderate-to-severe renal impairment not requiring hemodialysis. In addition to subjects with normal renal function and moderate renal impairment, Stage 2 of the study will also include cohorts of subjects requiring hemodialysis, subjects with severe renal impairment not requiring hemodialysis, and potentially subjects with mild renal impairment.

Inclusion criteria

• normal renal function or renal impairment
• stable hemodialysis treatment for at least 3 months before screening and able to tolerate a hemodialysis treatment lasting 3-4 hours with blood flow rates of >200mL/min (cohort 3 only)
• neither pregnant nor lactating
• HbA1c 6-10.5% inclusive
• females of childbearing potential must be practicing adequate contraception.

Exclusion criteria

• inability to meet the PK objectives of the study
• history of hypoglycemia unawareness or severe hypoglycemia
• liver function tests greater than or equal to 2 times the ULN
• clinically significant cardiovascular and/or cerebrovascular disease
• positive test results for hepatitis B, hepatitis C, or HIV
• documented hypertension or hypotension at screening
• known hepatic or biliary abnormalities
• current use of sulfonylureas
• active history of tobacco use within 6 months before screening
• donation of blood in excess of 500mL within 56 days before albiglutide dosing
• receipt of any investigational drug within the 30days or 5 half lives, whichever is longer, before dosing
• previous or current receipt of exenatide or any other GLP-1 agonist