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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Impairment; Diabetes Mellitus, Type 2

Intervention: albiglutide (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

Official title: 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.

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

To assess the PK of albiglutide in subjects with varying degrees of proteinuria

To assess the effects of hemodialysis on the overall PK profile of albiglutide

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

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.

Eligibility

Minimum age: 30 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

GSK Investigational Site, Somerset West 07129, South Africa

GSK Investigational Site, Anniston, Alabama 36207, United States

GSK Investigational Site, Miami, Florida 33169, United States

GSK Investigational Site, Orlando, Florida 32809, United States

GSK Investigational Site, Parktown, Gauteng 2193, South Africa

GSK Investigational Site, Baton Rouge, Louisiana 70806, United States

GSK Investigational Site, Minneapolis, Minnesota 55404, United States

Additional Information

Starting date: August 2009
Last updated: January 26, 2012

Page last updated: August 23, 2015

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