Last updated: 11/07/2018 05:09:40

Safety and efficacy study of albiglutide in type 2 diabetes

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GSK study ID
112756
See study documents
Clinicaltrials.gov ID
NCT00849017
See results summary
EudraCT ID
Not applicable
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 Two Dose Levels of Albiglutide Compared With Placebo in Subjects With Type 2 Diabetes Mellitus
Trial description: The purpose of this study is to determine whether albiglutide is effective in the treament of patients with 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

Change From Baseline in Postprandial Blood Glucose Profile Parameter-4 hour c-peptide AUC

Timeframe: Baseline and Week 52

Change From Baseline in Postprandial Blood Glucose Profile Parameter- 4 hour Blood Glucose AUC

Timeframe: Baseline and Week 52

Change From Baseline in Postprandial Blood Glucose Profile Parameters-4 hour insulin AUC and 4 hour proinsulin AUC

Timeframe: Baseline and Week 52

Albiglutide plasma concentration at Weeks 8 and 24

Timeframe: Weeks 8 and 24

Interventions:
  • Biological/vaccine: albiglutide
  • Biological/vaccine: albiglutide uptitration
  • Biological/vaccine: placebo
    • Enrollment:
    309
    Primary completion date:
    2011-17-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Nauck M, Stewart M, Perkins C, Jones-Leone A, Yang F, Perry C, Reinhardt R, Rendel Marc.HARMONY 2 PRIMARY ENDPOINT PUBLICATION THIRD RESUBMISSION: Week 52 Primary Endpoint Results: Once Weekly (QW) Glucagon-Like Peptide-1 Receptor Agonist Albiglutide (Albi) Monotherapy For Patients (Pts) With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled on Diet and Exercise .Diabetologia.2016;59:266-274.
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    albiglutide
    Collaborators
    Not applicable
    Study date(s)
    January 2009 to February 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
    • CHF 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 <6 weeks post-partum
    • CHF NYHA class III-IV

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    West Valley City, Utah, United States, 84120
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fort Worth, Texas, United States, 76104
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Greenville, South Carolina, United States, 29601
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    West Hills, California, United States, 91307
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Canal Fulton, Ohio, United States, 44614
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75251
    Status
    Study Complete
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    Showing 1 - 6 of 261 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
    2011-17-11
    Actual study completion date
    2013-22-02

    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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