Current partner codePEPTIDESDE
NCT00938158·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

75

Locations

7

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

BIOLOGICAL

albiglutide

single dose of subcutaneously injected albiglutide

Timeline

From registration to results.

  1. First posted

    Jul 13, 2009

  2. Study start

    Aug 5, 2009

  3. Primary completion

    Apr 12, 2011

  4. Study completion

    Apr 12, 2011

  5. Results posted

    Not reported

  6. Registry updated

    Jul 21, 2017

Outcomes

What the study measures.

Primary outcomes

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.

Time frame · 42 days

Secondary outcomes

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

Time frame · 42 days

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

Time frame · 42 days

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

Time frame · 42 days

Eligibility

Who can take part.

Minimum age
30 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

7 registered sites.

South Africa · United States. Showing up to 24 locations stored in the fast local snapshot.

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

Related trials

More studies on Albiglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.