Diabetes Mellitus, Type 2
Conditions
Keywords
albiglutide, hemodialysis, pharmacokinetics, renal
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.
Interventions
BIOLOGICALalbiglutide
single dose of subcutaneously injected albiglutide
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Africa, United States
Outcome results
None listed