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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00938158
First received: July 9, 2009
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Renal Impairment
Diabetes Mellitus, Type 2
 Biological: albiglutide
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the PK of albiglutide in subjects with varying degrees of proteinuria [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • To assess the effects of hemodialysis on the overall PK profile of albiglutide [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: August 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stage 1 normal renal function Biological: albiglutide
single dose of subcutaneously injected albiglutide
Experimental: Stage 1 moderate/severe renal function Biological: albiglutide
single dose of subcutaneously injected albiglutide
Experimental: Stage 2 normal renal function Biological: albiglutide
single dose of subcutaneously injected albiglutide
Experimental: Stage 2 moderate renal impairment Biological: albiglutide
single dose of subcutaneously injected albiglutide
Experimental: Stage 2 subjects requiring hemodialysis Biological: albiglutide
single dose of subcutaneously injected albiglutide
Experimental: Stage 2 severe renal impairment not requiring hemodialysis Biological: albiglutide
single dose of subcutaneously injected albiglutide
Experimental: Stage 2 mild renal impairment Biological: albiglutide
single dose of subcutaneously injected albiglutide

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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938158

Locations
United States, Alabama
GSK Investigational Site
Anniston, Alabama, United States, 36207
United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33169
GSK Investigational Site
Orlando, Florida, United States, 32809
United States, Louisiana
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70806
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
South Africa
GSK Investigational Site
Parktown, Gauteng, South Africa, 2193
GSK Investigational Site
Somerset West, South Africa, 07129
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00938158     History of Changes
Other Study ID Numbers: 108370
Study First Received: July 9, 2009
Last Updated: January 26, 2012
Health Authority: South Africa: Medicines Control Council
United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
albiglutide
hemodialysis
pharmacokinetics
renal

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013