Last updated: 11/07/2018 05:06:14

A study to determine the safety and efficacy of albiglutide in patients with type 2 diabetes

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GSK study ID
112754
See study documents
Clinicaltrials.gov ID
NCT00838916
See results summary
EudraCT ID
2008-007661-24
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, open-label, parallel-group, multicenter study to determine the efficacy and long-term safety of albiglutide compared with insulin in subjects with type 2 diabetes mellitus.
Trial description: A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
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 Week 156

Timeframe: Baseline and 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

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 body weight at Week 52

Timeframe: Baseline and Week 52

Change from Baseline in body weight at Week 156

Timeframe: Baseline and Week 156

Change from Baseline in glucose profile measured by 24-hour area under curve (AUC) at Week 52

Timeframe: Baseline and Week 52

Albiglutide plasma concentrations at Week 8 and Week 24

Timeframe: Weeks 8 and 24

Interventions:
  • Biological/vaccine: albiglutide
  • Drug: insulin glargine
    • Enrollment:
    779
    Primary completion date:
    2012-23-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Peter Weissman, Molly C. Carr, June Ye, Deborah Cirkel, Murray Stewart, Caroline Perry, and Richard Pratley. HARMONY 4 PRIMARY ENDPOINT PUBLICATION: Once weekly GLP-1 Receptor Agonist Albiglutide vs Insulin Glargine in Patients With Type 2 Diabetes Mellitus at Week 52.Diabetologia.2014
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    albiglutide
    Collaborators
    Not applicable
    Study date(s)
    February 2009 to May 2013
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • type 2 diabetes
    • BMI 20-45kg/m2 inclusive
    • females who are pregnant, lactating or within <6 weeks post-partum
    • current symptomatic heart failure (NYHA Class III-IV)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • type 2 diabetes
    • BMI 20-45kg/m2 inclusive
    Exclusion criteria:
    • females who are pregnant, lactating or within <6 weeks post-partum
    • current symptomatic heart failure (NYHA Class III-IV)

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Hampton, Virginia, United States, 23666
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Calabash, North Carolina, United States, 28467
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fort Worth, Texas, United States, 76135
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Orem, Utah, United States, 84058
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Dearborn, Michigan, United States, 48124
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lakewood, California, United States, 90712
    Status
    Study Complete
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    Showing 1 - 6 of 337 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
    2012-23-01
    Actual study completion date
    2013-30-05

    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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