A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.
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.
1 other identifier
interventional
75
2 countries
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes-mellitus-type-2
Started Aug 2009
Longer than P75 for phase_1 diabetes-mellitus-type-2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2009
CompletedFirst Posted
Study publicly available on registry
July 13, 2009
CompletedStudy Start
First participant enrolled
August 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2011
CompletedJuly 21, 2017
July 1, 2017
1.7 years
July 9, 2009
July 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
To assess the PK of albiglutide in subjects with varying degrees of proteinuria
42 days
To assess the effects of hemodialysis on the overall PK profile of albiglutide
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
42 days
Study Arms (7)
Stage 1 normal renal function
EXPERIMENTALSubject with estimated glomerular filtration rate (GFR) greater than 80 milliliter per minute (mL/min)
Stage 1 moderate/severe renal function
EXPERIMENTALSubject with estimated GFR \>= 20 mL/min and less than 50 mL/min
Stage 2 normal renal function
EXPERIMENTALSubject with GFR greater than 80 mL/min
Stage 2 moderate renal impairment
EXPERIMENTALSubject with estimated GFR \>= 30 mL/min and less than 50 mL/min
Stage 2 subjects requiring hemodialysis
EXPERIMENTALSubjects who require hemodialysis
Stage 2 severe renal impairment not requiring hemodialysis
EXPERIMENTALSubjects with GFR less than 30 mL/min
Stage 2 mild renal impairment
EXPERIMENTALSubjects with GFR \>= 50 mL/min and \<= 80 mL/min
Interventions
single dose of subcutaneously injected albiglutide
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (7)
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
Baton Rouge, Louisiana, 70806, United States
GSK Investigational Site
Minneapolis, Minnesota, 55404, United States
GSK Investigational Site
Parktown, Gauteng, 2193, South Africa
GSK Investigational Site
Somerset West, 07129, South Africa
Related Publications (2)
Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.
PMID: 25387217DERIVEDYoung MA, Wald JA, Matthews JE, Yang F, Reinhardt RR. Effect of renal impairment on the pharmacokinetics, efficacy, and safety of albiglutide. Postgrad Med. 2014 May;126(3):35-46. doi: 10.3810/pgm.2014.05.2754.
PMID: 24918790DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2009
First Posted
July 13, 2009
Study Start
August 5, 2009
Primary Completion
April 12, 2011
Study Completion
April 12, 2011
Last Updated
July 21, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.