A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.
Diabetes Mellitus, Type 2

About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring albiglutide, hemodialysis, pharmacokinetics, renal
Eligibility Criteria
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
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Stage 1 normal renal function
Stage 1 moderate/severe renal function
Stage 2 normal renal function
Stage 2 moderate renal impairment
Stage 2 subjects requiring hemodialysis
Stage 2 severe renal impairment not requiring hemodialysis
Stage 2 mild renal impairment
Subject with estimated glomerular filtration rate (GFR) greater than 80 milliliter per minute (mL/min)
Subject with estimated GFR >= 20 mL/min and less than 50 mL/min
Subject with GFR greater than 80 mL/min
Subject with estimated GFR >= 30 mL/min and less than 50 mL/min
Subjects who require hemodialysis
Subjects with GFR less than 30 mL/min
Subjects with GFR >= 50 mL/min and <= 80 mL/min