Last updated: 11/07/2018 05:04:12

Efficacy and safety of albiglutide in treatment of type 2 diabetes

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GSK study ID
112753
See study documents
Clinicaltrials.gov ID
NCT00838903
See results summary
EudraCT ID
2008-007660-41
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 and Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Metformin Compared With Metformin Plus Sitagliptin, Metformin Plus Glimepiride, and Metformin Plus Placebo in Subjects With Type 2 Diabetes Mellitus
Trial description: The purpose of this study is to determine if albiglutide is safe and effective 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 104

Timeframe: Baseline and Week 104

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 104

Timeframe: Baseline and Week 104

Change from Baseline in 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 104

Timeframe: Week 104

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 104

Timeframe: Baseline and Week 104

Change from Baseline in body weight at Week 156

Timeframe: Baseline and Week 156

Interventions:
  • Biological/vaccine: albiglutide
  • Drug: sitagliptin
  • Drug: glimepiride
  • Drug: metformin
  • Biological/vaccine: placebo albiglutide
  • Drug: placebo sitagliptin
  • Drug: placebo glimepiride
    • Enrollment:
    1049
    Primary completion date:
    2012-31-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Ahrén B, Stewart M, Cirkel D, Yang F, Perry C, Johnson S; Feinglos M.HARMONY 3 PRIMARY ENDPOINT PUBLICATION : Weekly GLP-1 Receptor Agonist Albiglutide is Superior to Sitagliptin or Glimepiride in Patients with Type 2 Diabetes Mellitus on Metformin at the 104 Week Primary Endpoint .Diabetes Care.2014;37:2141-2148
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    albiglutide
    Collaborators
    Not applicable
    Study date(s)
    February 2009 to April 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 <6 weeks post-partum
    • current symptomatic heart failure (NYHA Class III or IV)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • type 2 diabetes
    • BMI 20-45kg/m2 inclusive
    Exclusion criteria:
    • females who are pregnant, lactating or <6 weeks post-partum
    • current symptomatic heart failure (NYHA Class III or IV)

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10115
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Somerset West, South Africa, 07129
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63117
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hull, United Kingdom, HU3 2RW
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbus, Ohio, United States, 43212
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Hialeah, Florida, United States, 33013
    Status
    Study Complete
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    Showing 1 - 6 of 384 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
    2012-31-01
    Actual study completion date
    2013-01-04

    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

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