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

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938158
• Other study ID #: 108370
• Status: Completed
• Phase: Phase 1
• First received: July 9, 2009
• Last updated: July 18, 2017
• Start date: August 5, 2009
• Est. completion date: April 12, 2011

Study information

• Verified date: July 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 12, 2011
• Est. primary completion date: April 12, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Biological:
• albiglutide
single dose of subcutaneously injected albiglutide

Locations

Country	Name	City	State
South Africa	GSK Investigational Site	Parktown	Gauteng
South Africa	GSK Investigational Site	Somerset West
United States	GSK Investigational Site	Anniston	Alabama
United States	GSK Investigational Site	Baton Rouge	Louisiana
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess the PK of albiglutide in subjects with varying degrees of proteinuria		42 days
Secondary	To assess the effects of hemodialysis on the overall PK profile of albiglutide		42 days
Secondary	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

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 108370 can be found on the GSK Clinical Study Register.