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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
albiglutide
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring albiglutide, hemodialysis, pharmacokinetics, renal

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Stage 1 normal renal function

Stage 1 moderate/severe renal function

Stage 2 normal renal function

Stage 2 moderate renal impairment

Stage 2 subjects requiring hemodialysis

Stage 2 severe renal impairment not requiring hemodialysis

Stage 2 mild renal impairment

Arm Description

Subject with estimated glomerular filtration rate (GFR) greater than 80 milliliter per minute (mL/min)

Subject with estimated GFR >= 20 mL/min and less than 50 mL/min

Subject with GFR greater than 80 mL/min

Subject with estimated GFR >= 30 mL/min and less than 50 mL/min

Subjects who require hemodialysis

Subjects with GFR less than 30 mL/min

Subjects with GFR >= 50 mL/min and <= 80 mL/min

Outcomes

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.

Secondary Outcome Measures

To assess the PK of albiglutide in subjects with varying degrees of proteinuria
To assess the effects of hemodialysis on the overall PK profile of albiglutide
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

Full Information

First Posted
July 9, 2009
Last Updated
July 18, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00938158
Brief Title
A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 5, 2009 (Actual)
Primary Completion Date
April 12, 2011 (Actual)
Study Completion Date
April 12, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
albiglutide, hemodialysis, pharmacokinetics, renal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stage 1 normal renal function
Arm Type
Experimental
Arm Description
Subject with estimated glomerular filtration rate (GFR) greater than 80 milliliter per minute (mL/min)
Arm Title
Stage 1 moderate/severe renal function
Arm Type
Experimental
Arm Description
Subject with estimated GFR >= 20 mL/min and less than 50 mL/min
Arm Title
Stage 2 normal renal function
Arm Type
Experimental
Arm Description
Subject with GFR greater than 80 mL/min
Arm Title
Stage 2 moderate renal impairment
Arm Type
Experimental
Arm Description
Subject with estimated GFR >= 30 mL/min and less than 50 mL/min
Arm Title
Stage 2 subjects requiring hemodialysis
Arm Type
Experimental
Arm Description
Subjects who require hemodialysis
Arm Title
Stage 2 severe renal impairment not requiring hemodialysis
Arm Type
Experimental
Arm Description
Subjects with GFR less than 30 mL/min
Arm Title
Stage 2 mild renal impairment
Arm Type
Experimental
Arm Description
Subjects with GFR >= 50 mL/min and <= 80 mL/min
Intervention Type
Biological
Intervention Name(s)
albiglutide
Intervention Description
single dose of subcutaneously injected albiglutide
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To assess the PK of albiglutide in subjects with varying degrees of proteinuria
Time Frame
42 days
Title
To assess the effects of hemodialysis on the overall PK profile of albiglutide
Time Frame
42 days
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
GSK Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70806
Country
United States
Facility Name
GSK Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
GSK Investigational Site
City
Parktown
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
GSK Investigational Site
City
Somerset West
ZIP/Postal Code
07129
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
25387217
Citation
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.
Results Reference
derived
PubMed Identifier
24918790
Citation
Young 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.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108370
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108370
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108370
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108370
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108370
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108370
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108370
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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