Last updated: 02/06/2024 05:51:18
Cross-sectional survey to evaluate quality-of-life impact of GLP-1–related nausea and vomiting in T2DM patients
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Cross-sectional survey to evaluate quality-of-life impact of GLP-1–related nausea and vomiting in T2DM patients
Trial description: GlaxoSmithKline (GSK) has recently launched a glucagon-like peptide-1 (GLP-1) therapy for Type 2 Diabetes Mellitus (T2DM) - albiglutide, a biological, injectable form of human GLP-1. The results of a phase 3 trial (HARMONY7) evaluating the efficacy and safety of albiglutide relative to liraglutide showed that the percentage of subjects who experienced nausea and vomiting in the first 12 weeks of treatment with albiglutide was smaller than for liraglutide. To better understand the potential advantages of albiglutide, there is a need to measure the impact of GLP-1–induced nausea and vomiting in real-world settings. To begin addressing this need, GSK has developed a 15-item questionnaire to capture aspects of patient burden related to nausea (N) and/or vomiting (V) while receiving a GLP-1 agonist (NV Questionnaire) for T2DM. GSK wishes to field test this NV questionnaire in order to evaluate the psychometric properties and gather real-world data to characterize the impact of GLP-1–induced nausea and/or vomiting on patients with T2DM in the United States (US).The primary objective of this research study is to assess the impact of GLP-1–related nausea and/or vomiting on patients with T2DM based on their responses to the NV Questionnaire and a survey designed to gather health-related quality of life (HRQOL) and health economic impacts (for example, use of over-the-counter medications, presenteeism, absenteeism).The current study is a cross-sectional, web-based survey in the US among patients who self-report T2DM (age 18+) and have pharmacy claim evidence of current treatment with a GLP-1 agonist. Subjects will be identified using a national retail pharmacy database, selecting those subjects who have filled a prescription for a GLP-1 agonist, as specified in the eligibility criteria, in the past 90 days. The maximum overall data-collection period planned in this study is 12 weeks.All trade marks, trade names, and product names contained herein are the property of their respective owners.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Impact of nausea and/or vomiting on health-related quality of life (HRQOL)
Timeframe: Once, any time during a maximum period of 12 weeks
Self-reported clinical information
Timeframe: Once, any time during a maximum period of 12 weeks
Self-reported treatment adherence
Timeframe: Once, any time during a maximum period of 12 weeks
Nausea- and/or vomiting-related resource utilization
Timeframe: Once, any time during a maximum period of 12 weeks
Work days missed and productivity losses (over the past 7 days) associated with nausea/vomiting
Timeframe: Once, any time during a maximum period of 12 weeks
Secondary outcomes:
Documentation of the psychometric properties of the NV Questionnaire
Timeframe: Upon data collection of a maximum period of 12 weeks
Interventions:
Other: Nausea Vomiting (NV) Questionnaire
Other: Medical Outcomes Study 12-Item Short-Form Health Survey (SF-12)
Other: Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire
Other: Questionnaire on miscellaneous items
Other: Functional Living Index-Emesis (FLIE)
Enrollment:
200
Observational study model:
Case-Only
Primary completion date:
2016-26-09
Time perspective:
Cross-Sectional
Clinical publications:
Not applicable
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
RTI Health Solutions
Study date(s)
August 2016 to September 2016
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Participant is aged 18 years or older.
- Participant self-reports having received a diagnosis of T2DM from his or her doctor or other health care professional at least 12 months before study entry.
- Participant has filled a prescription for a GLP-1 agonist for an indication other than T2DM; for example, weight loss based on an NDC - SAXENDA® (liraglutide) injection solution: 0169-2800-15, 0169-2800-90, 0169-2800-97
- Participant self-reports using an office drug sample (as a first trial) of the GLP-1 agonist as provided by their health care professional. (This criterion is intended to ensure that participants will be receiving the GLP-1 for the first time from the pharmacy. It may be relaxed if more than 50% of respondents fail the screener during the first week of data collection due to ONLY this criterion.)
Inclusion and exclusion criteria
Inclusion criteria:
- Participant is aged 18 years or older.
- Participant self-reports having received a diagnosis of T2DM from his or her doctor or other health care professional at least 12 months before study entry.
- Participant has been prescribed one of the following GLP-1 agonist based on a national drug code (NDC): BYDUREON® (exenatide) injection, suspension, extended release: 00310-6520-04, 00310-6530-01, 00310-6530-04, 00310-6530-85; BYDUREON (exenatide) Kit: 66780-0219-02, 66780-0219-04, 66780-0221-01, 66780-0226-01; BYETTA® (exenatide) injection: 66780-0210-07, 66780-0210-09, 66780-0212-01; BYETTA (exenatide) injection: 00310-6512-01, 00310-6524-01, 54868-5384-00, 54868-5384-01; TANZEUM™ (albiglutide) injection, powder, lyophilized, solution: 00173-0866-02, 00173-0866-35, 00173-0866-61, 00173-0867-02, 00173-0867-35, 00173-0867-61; TRULICITY™ (dulaglutide) injection: 0002-1433-01, 0002-1433-61, 0002-1433-80, 0002-1434-01, 0002-1434-61, 0002-1434-80; VICTOZA® (liraglutide recombinant deoxyribonucleic acid [rDNA] origin) injection solution: 00169-4060-12, 00169-4060-13, 00169-4060-90, 00169-4060-97, 00169-4060-98, 00169-4060-99.
- Participant self-reports using their GLP-1 agonist for less than 3 months.
- Participant self-reports nausea and/or vomiting when using their GLP-1 agonist.
- Participant is able to complete the questionnaire in English.
- Participant is able to provide consent.
Exclusion criteria:
- Participant has filled a prescription for a GLP-1 agonist for an indication other than T2DM; for example, weight loss based on an NDC
- SAXENDA® (liraglutide) injection solution: 0169-2800-15, 0169-2800-90, 0169-2800-97
- Participant self-reports using an office drug sample (as a first trial) of the GLP-1 agonist as provided by their health care professional. (This criterion is intended to ensure that participants will be receiving the GLP-1 for the first time from the pharmacy. It may be relaxed if more than 50% of respondents fail the screener during the first week of data collection due to ONLY this criterion.)
- Participant self-reports having a severe gastric disease, such as severe gastroparesis requiring therapy within 6 months prior to study entry.
- Participant self-reports history of significant gastrointestinal surgery likely to significantly affect upper gastrointestinal or pancreatic function (for example, gastric bypass and banding, antrectomy, Roux en Y bypass, gastric vagotomy, small bowel resection).
Trial location(s)
No location data available.
Study documents
Protocol
Available language(s): English
Scientific result summary
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
2016-26-09
Actual study completion date
2016-26-09
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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