A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Biological: albiglutide
- Registration Number
- NCT00938158
- Lead Sponsor
- GlaxoSmithKline
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stage 2 subjects requiring hemodialysis albiglutide Subjects who require hemodialysis Stage 2 moderate renal impairment albiglutide Subject with estimated GFR \>= 30 mL/min and less than 50 mL/min Stage 2 normal renal function albiglutide Subject with GFR greater than 80 mL/min Stage 1 moderate/severe renal function albiglutide Subject with estimated GFR \>= 20 mL/min and less than 50 mL/min Stage 2 severe renal impairment not requiring hemodialysis albiglutide Subjects with GFR less than 30 mL/min Stage 1 normal renal function albiglutide Subject with estimated glomerular filtration rate (GFR) greater than 80 milliliter per minute (mL/min) Stage 2 mild renal impairment albiglutide Subjects with GFR \>= 50 mL/min and \<= 80 mL/min
- Primary Outcome Measures
Name Time Method 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. 42 days
- Secondary Outcome Measures
Name Time Method To assess the PK of albiglutide in subjects with varying degrees of proteinuria 42 days To assess the effects of hemodialysis on the overall PK profile of albiglutide 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 42 days
Trial Locations
- Locations (1)
GSK Investigational Site
πΏπ¦Somerset West, South Africa