A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:30 - 75
Updated:12/2/2016
Start Date:August 2009
End Date:April 2011

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An Adaptive Design Study for the Assessment of the Pharmacokinetics of Albiglutide in Subjects With Normal Renal Function and Subjects With Moderate-to-severe Renal Impairment and Hemodialysis.

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.

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
We found this trial at
6
sites
Anniston, Alabama 36207
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Baton Rouge, Louisiana 70809
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Baton Rouge, LA
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Miami, Florida 33136
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Miami, FL
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Minneapolis, Minnesota 55404
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Minneapolis, MN
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Orlando, Florida 32806
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Orlando, FL
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Parktown, Gauteng 2193
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Parktown,
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