Last updated: 01/29/2020 18:40:09

An Interview Study in Adult Patients with Type 2 Diabetes Mellitus Using the Albiglutide Pen Injector

GSK study ID
206209
See study documents
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: An Interview Study in Adult Patients with Type 2 Diabetes Mellitus Using the Albiglutide Pen Injector
Trial description: Albiglutide is a subcutaneous injection administered using pen injector to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes mellitus (T2DM). A number of individuals using albiglutide pen injector have experienced difficulties preparing and administering the medication, despite receiving training from diabetes nurse educators. This health outcome interview study will be conducted to develop subject questionnaire to assess experience with the albiglutide pen injector. Telephonic interviews will be conducted with a total of approximately 30 individuals with T2DM who are either using albiglutide pen injector or have recently discontinued (<= 1 month) it and they or their caregivers have reported an issue to the albiglutide pen injector support line.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Concept-elicitation (CE) interviews with individuals (subjects or caregivers) who have experienced issues with the use of albiglutide pen injector

Timeframe: Approximately 26 days

Combine CE and cognitive debriefing (CD) interviews for better understanding of the issues related to albiglutide pen injector and evaluate the content, clarity, and relevance of the subject questionnaire

Timeframe: Approximately 21 days

Revised the subject reported measure, based on findings from the combined CE and CD interviews, for use in an upcoming survey study

Timeframe: Approximately 9 days

Secondary outcomes:
Not applicable
Interventions:
  • Device: Albiglutide injection pen injector
    • Enrollment:
    0
    Primary completion date:
    2016-09-11
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    albiglutide
    Collaborators
    Health outcomes solutions, outcomes research vendor
    Study date(s)
    August 2016 to November 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • For Subjects:
    • Have a diagnosis of T2DM
    • For subjects and caregivers:
    • Presence of a medical or psychiatric condition or treatment for condition that results in a cognitive or other (visual, hearing) impairment that would interfere with participating in the study (based on HOS’ opinion)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • For Subjects:
    • Have a diagnosis of T2DM
    • Currently using or recently discontinued albiglutide pen injector within the past month
    • Have reported an issue to the albiglutide pen injector support Line, related to the use of albiglutide pen injector
    • United States (US) resident
    • Able to speak, read and write in English
    • Able to provide informed consent
    • Willing to take part in one interview lasting no more than 60 minutes each
    • Willing to review training materials and complete a draft questionnaire (if asked) For caregivers:
    • Currently or within the past month responsible for the preparation and administration of albiglutide pen injector for an individual with T2DM
    • Have reported an issue to the albiglutide pen injector support line, related to the use of albiglutide pen injector
    • US resident
    • Able to speak, read and write in English
    • Able to provide informed consent
    • Willing to take part in one interview lasting no more than 60 minutes each
    • Willing to review training materials and complete a questionnaire (if asked)
    Exclusion criteria:
    • For subjects and caregivers:
    • Presence of a medical or psychiatric condition or treatment for condition that results in a cognitive or other (visual, hearing) impairment that would interfere with participating in the study (based on HOS’ opinion)

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

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

    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
    2016-09-11
    Actual study completion date
    2016-09-11

    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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