Last updated: 11/07/2018 12:19:46

Indirect Comparison of Albiglutide and Exenatide QW using the Bucher method

GSK study ID
201670
Clinicaltrials.gov ID
Not applicable
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: Indirect Comparison of Albiglutide and Exenatide QW using the Bucher method
Trial description: An indirect comparison of efficacy on blood glucose control, as measured by change from baseline in HbA1c, with albiglutide 50mg once weekly and exenatide 2mg once weekly. The objective is to determine whether albiglutide 50mg and exenatide 2mg are of comparable efficacy. The indirect comparison will be conducted using two studies: HARMONY 7, a 32-week, randomised, open-label study in adults with type 2 diabetes inadequately controlled on oral therapy, comparing albiglutide 50mg once weekly and liraglutide 1.8mg once daily; and DURATION 6: a 26 week, open-label, randomised study in adults with type 2 diabetes uncontrolled with oral antihyperglycaemic drugs, comparing once weekly exenatide 2mg and once-daily liraglutide 1.8 mg. The analysis will be conducted using the Bucher method, a technique for indirectly comparing two treatments that have both been compared to a third treatment. In this case, liraglutide 1.8mg once daily is the common comparator.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Blood glucose control measured as the change from baseline in HbA1c

Timeframe: 32 weeks

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Exenatide
  • Drug: Albiglutide
  • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Alan Martin, Daniel Parks. Indirect Comparison of Hb1Ac treatment effect with albiglutide and exenatide QW suing the Bucher Method. Diabetes Metab Syndrome Obes. 2016;9:163-168.
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    albiglutide, exenatide
    Collaborators
    Not applicable
    Study date(s)
    May 2014 to June 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Inclusion Criteria:
    • Patients with type 2 diabetes

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

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

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

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2014-23-06

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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