BIOLOGICAL
albiglutide
single dose of subcutaneously injected albiglutide
Status
Completed
Phase
Phase 1
Enrollment
75
Locations
7
Results
Not posted
Publications
2
Study summary
The purpose of this study is to assess 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, including subjects requiring hemodialysis.
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.
Interventions
BIOLOGICAL
single dose of subcutaneously injected albiglutide
Timeline
First posted
Jul 13, 2009
Study start
Aug 5, 2009
Primary completion
Apr 12, 2011
Study completion
Apr 12, 2011
Results posted
Not reported
Registry updated
Jul 21, 2017
Outcomes
The primary objective is to characterize the PK of albiglutide in subjects with type 2 diabetes and varying degrees of renal impairment, including subjects requiring hemodialysis, and in age, gender and BMI-matched subjects.
Time frame · 42 days
To assess the PK of albiglutide in subjects with varying degrees of proteinuria
Time frame · 42 days
To assess the effects of hemodialysis on the overall PK profile of albiglutide
Time frame · 42 days
To assess the safety and tolerability of a single dose of albiglutide in subjects with varying degrees of renal impairment and in age, gender and BMI-matched subjects with normal renal function
Time frame · 42 days
Eligibility
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
Study locations
South Africa · United States. Showing up to 24 locations stored in the fast local snapshot.
GSK Investigational Site
Anniston, Alabama, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Baton Rouge, Louisiana, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
Parktown, Gauteng, South Africa
GSK Investigational Site
Somerset West, South Africa
Publications
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