Last updated: 01/29/2020 18:40:09
An Interview Study in Adult Patients with Type 2 Diabetes Mellitus Using the Albiglutide Pen Injector
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2016-09-11
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)
No location data available.
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
Finalized
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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