Last updated: 02/26/2019 14:00:19

Quantitative Testing of Prescriber Knowledge about TANZEUMTM (albiglutide) Safety and Use Information

GSK study ID
207524
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: Quantitative Testing of Prescriber Knowledge about TANZEUMTM (albiglutide) Safety and Use Information
Trial description: This is a survey designed to assess prescribers’ knowledge regarding the risks and safe use of albiglutide (TANZEUM, it is a trademark owned by GlaxoSmithKline [GSK]). The results of this survey together with other Risk Evaluation and Mitigation Strategy (REMS) evaluation metrics, will be used to determine the effectiveness of the REMS in mitigating the risks of albiglutide. This data will also be used to assess if changes are needed to the REMS materials to make them more effective in achieving the goal of the REMS. The survey will be implemented in 3 parts, known as waves, so that data will be available for inclusion in the REMS assessment reports submitted to the Food and Drug Administration (FDA) at 18 months (Wave 1), 3 years (Wave 2), and 7 years (Wave 3) from the date of albiglutide REMS approval.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of prescriber having knowledge of potential risk of medullary thyroid carcinoma (MTC) with use of albiglutide

Timeframe: Up to 7 years

Number of prescriber having knowledge on risk of acute pancreatitis with use of albiglutide

Timeframe: Up to 7 years

Number of prescriber having knowledge on evaluation of patients who develop symptoms suggestive of pancreatitis after use of albiglutide

Timeframe: Up to 7 years

Number of prescriber having knowledge of prescriber on characteristics of the appropriate patient population for which TANZEUM should be prescribed with use of albiglutide

Timeframe: Up to 7 years

Secondary outcomes:
Not applicable
Interventions:
  • Other: Questionnaire administration
    • Enrollment:
    1
    Primary completion date:
    2017-30-03
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Carol Koro, Janet Pientka, Veronica Bainbridge, Natalie O’Donnell, Monika Stender, Annette Stemhagen. Quantitative Testing of Prescriber Knowledge Regarding the Risks and Safe Use of Albiglutide. Drugs Real World Outcomes. 2018;5(1):55-67.
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    albiglutide
    Collaborators
    United Biosource Corporation (UBC)
    Study date(s)
    November 2016 to March 2017
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    Yes
    • For Wave 1 only, HCPs who have prescribed albiglutide at least once
    • For Wave 2 and Wave 3 surveys, HCPs who have prescribed albiglutide at least once in the previous 12 months
    • HCPs who have ever worked for or whose immediate family members have ever worked for GSK, United BioSource Corporation (UBC), or the FDA
    • For Wave 2 and Wave 3 surveys, HCPs who have participated in Qualitative Research (QR) or who have participated in a previous albiglutide knowledge survey
    Inclusion and exclusion criteria
    Inclusion criteria:
    • For Wave 1 only, HCPs who have prescribed albiglutide at least once
    • For Wave 2 and Wave 3 surveys, HCPs who have prescribed albiglutide at least once in the previous 12 months
    Exclusion criteria:
    • HCPs who have ever worked for or whose immediate family members have ever worked for GSK, United BioSource Corporation (UBC), or the FDA
    • For Wave 2 and Wave 3 surveys, HCPs who have participated in Qualitative Research (QR) or who have participated in a previous albiglutide knowledge survey

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    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
    2017-30-03
    Actual study completion date
    2017-30-03

    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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