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

Completed · Phase 1

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00938158

Run by

GlaxoSmithKline

People needed

75

Starts

2009-08-05

Expected to finish

2011-04-12

Last updated by the study team

2017-07-21

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.