Last updated: 11/07/2018 02:11:56
A study of the pharmacokinetics of albiglutide in normal and renally impaired subjects.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
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.
Timeframe: 42 days
Secondary outcomes:
To assess the PK of albiglutide in subjects with varying degrees of proteinuria
Timeframe: 42 days
To assess the effects of hemodialysis on the overall PK profile of albiglutide
Timeframe: 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
Timeframe: 42 days
Interventions:
Biological/vaccine: albiglutide
Enrollment:
75
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Malcolm A. Young, PhD, Jeffrey A. Wald, PhD, Jessica E. Matthews, BS, Rickey Reinhardt, MD, PhD .Effect of Renal Impairment on the Pharmacokinetics, Efficacy, and Safety of Albiglutide.Postgrad Med.2014;126(3):36-46
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
GSK
Study date(s)
August 2009 to April 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
30 - 75 years
Accepts healthy volunteers
No
- 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)
- inability to meet the PK objectives of the study
- history of hypoglycemia unawareness or severe hypoglycemia
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70806
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Parktown, Gauteng, South Africa, 2193
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Somerset West, South Africa, 07129
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Orlando, Florida, United States, 32809
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Anniston, Alabama, United States, 36207
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2011-12-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Results for study 108370 can be found on the GSK Clinical Study Register.
Click hereResearchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website