Status:
COMPLETED
A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
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 f...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 5 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2011
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00938158
Start Date
August 5 2009
End Date
April 12 2011
Last Update
July 21 2017
Active Locations (7)
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1
GSK Investigational Site
Anniston, Alabama, United States, 36207
2
GSK Investigational Site
Miami, Florida, United States, 33169
3
GSK Investigational Site
Orlando, Florida, United States, 32809
4
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70806