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

July 18, 2017 updated by: GlaxoSmithKline

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Somerset West, South Africa, 07129
        • GSK Investigational Site
    • Gauteng
      • Parktown, Gauteng, South Africa, 2193
        • GSK Investigational Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • GSK Investigational Site
    • Florida
      • Miami, Florida, United States, 33169
        • GSK Investigational Site
      • Orlando, Florida, United States, 32809
        • GSK Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70806
        • GSK Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stage 1 normal renal function
Subject with estimated glomerular filtration rate (GFR) greater than 80 milliliter per minute (mL/min)
Biological: albiglutide
single dose of subcutaneously injected albiglutide
Experimental: Stage 1 moderate/severe renal function
Subject with estimated GFR >= 20 mL/min and less than 50 mL/min
Biological: albiglutide
single dose of subcutaneously injected albiglutide
Experimental: Stage 2 normal renal function
Subject with GFR greater than 80 mL/min
Biological: albiglutide
single dose of subcutaneously injected albiglutide
Experimental: Stage 2 moderate renal impairment
Subject with estimated GFR >= 30 mL/min and less than 50 mL/min
Biological: albiglutide
single dose of subcutaneously injected albiglutide
Experimental: Stage 2 subjects requiring hemodialysis
Subjects who require hemodialysis
Biological: albiglutide
single dose of subcutaneously injected albiglutide
Experimental: Stage 2 severe renal impairment not requiring hemodialysis
Subjects with GFR less than 30 mL/min
Biological: albiglutide
single dose of subcutaneously injected albiglutide
Experimental: Stage 2 mild renal impairment
Subjects with GFR >= 50 mL/min and <= 80 mL/min
Biological: albiglutide
single dose of subcutaneously injected albiglutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
42 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the PK of albiglutide in subjects with varying degrees of proteinuria
Time Frame: 42 days
42 days
To assess the effects of hemodialysis on the overall PK profile of albiglutide
Time Frame: 42 days
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
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2009

Primary Completion (Actual)

April 12, 2011

Study Completion (Actual)

April 12, 2011

Study Registration Dates

First Submitted

July 9, 2009

First Submitted That Met QC Criteria

July 9, 2009

First Posted (Estimate)

July 13, 2009

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108370

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Statistical Analysis Plan
    Information identifier: 108370
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individual Participant Data Set
    Information identifier: 108370
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: 108370
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: 108370
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: 108370
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Informed Consent Form
    Information identifier: 108370
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annotated Case Report Form
    Information identifier: 108370
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on albiglutide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe