Last updated: 11/07/2018 05:08:05

Safety and efficacy of albiglutide in type 2 diabetes

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GSK study ID
112755
See study documents
Clinicaltrials.gov ID
NCT00849056
See results summary
EudraCT ID
2008-007662-37
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Pioglitazone With or Without Metformin in Subjects with Type 2 Diabetes Mellitus
Trial description: The purpose of this study is to determine the safety, tolerability and efficacy of albiglutide in the treatment of type 2 diabetes.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from Baseline (BL) in glycosylated hemoglobin (HbA1c) at Week 52

Timeframe: Baseline and Week 52

Secondary outcomes:

Change from Baseline in HbA1c at Weeks 104 and 156

Timeframe: Baseline and Weeks 104 and 156

Time to hyperglycemia rescue

Timeframe: From the start of study medication until the end of the treatment (up to Week 156)

Change from Baseline in fasting plasma glucose (FPG) at Week 52

Timeframe: Baseline and Week 52

Change from Baseline in fasting plasma glucose (FPG) at Week 156

Timeframe: Baseline and Week 156

Number of participants who achieved clinically meaningful HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52

Timeframe: Week 52

Number of participants who achieved clinically meaningful HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156

Timeframe: Week 156

Change from Baseline in body weight at Week 52

Timeframe: Baseline and Week 52

Change from Baseline in body weight at Week 156

Timeframe: Baseline and Week 156

Interventions:
  • Biological/vaccine: albiglutide
  • Drug: placebo
    • Enrollment:
    310
    Primary completion date:
    2011-04-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Reusch J, Stewart M, Perkins C, Ye J, Perry C, Cirkel D, Reinhardt R, Bode B.Efficacy and safety of once weekly GLP-1 receptor agonist albiglutide (HARMONY 1): 52 week primary endpoint results from a randomized, double-blind, placebo controlled, trial in patients with type 2 diabetes mellitus not controlled on pioglitazone ± metformin.Diabetes Obes Metab.2014;16:1257-1264
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    albiglutide
    Collaborators
    Not applicable
    Study date(s)
    January 2009 to January 2013
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • type 2 diabetes
    • BMI 20-45kg/m2
    • NYHA Class II to IV heart failure
    • females who are pregnant, lactating, or less than 6 weeks post-partum
    Inclusion and exclusion criteria
    Inclusion criteria:
    • type 2 diabetes
    • BMI 20-45kg/m2
    Exclusion criteria:
    • NYHA Class II to IV heart failure
    • females who are pregnant, lactating, or less than 6 weeks post-partum

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Melrose Park, Pennsylvania, United States, 19027
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbia, South Carolina, United States, 29201
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Arequipa, Arequipa, Peru, 54
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chattanooga, Tennessee, United States, 37421
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89106
    Status
    Study Complete
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    Showing 1 - 6 of 331 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2011-04-11
    Actual study completion date
    2013-18-01

    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

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