- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05737810
Attitudes and Unmet Needs Among Type 2 Diabetes Patients
May 12, 2023 updated by: Novo Nordisk A/S
The main purpose of this study is to explore experiences and understand the unmet needs of people with Type 2 Diabetes (T2D) among those who are being managed with basal insulin and those who are insulin naïve in order to understand perspectives for a once weekly insulin option; including any potential barriers to being managed with insulin therapy overall.
Study participants will be recruited to complete a 15-minute self-administered online survey.
Study Overview
Study Type
Observational
Enrollment (Actual)
700
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sydney, Australia
- Novo Nordisk INvestigational Site
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Chartres, France
- Novo Nordisk INvestigational Site
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Bengaluru, India
- Novo Nordisk INvestigational Site
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Seoul, Korea, Republic of
- Novo Nordisk INvestigational Site
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Mexico City, Mexico
- Novo Nordisk INvestigational Site
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Riyadh, Saudi Arabia
- Novo Nordisk INvestigational Site
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London, United Kingdom
- Novo Nordisk INvestigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
The main purpose of this study is to explore experiences and understand the unmet needs of people with Type 2 Diabetes among those who are being managed with basal insulin and those who are insulin naïve in order to understand perspectives for a once weekly insulin option; including any potential barriers to being managed with insulin therapy overall.
Description
Inclusion Criteria:
- Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- Male or female, age above or equal between 18 to 65 years at the time of signing informed consent.
- Diagnosed with T2D and currently treating T2D with at least one medication
- Insulin user that is not using insulin pump
- Lives in a target country
Exclusion Criteria:
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Does not meet inclusion criteria requirements
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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People with Type 2 Diabetes
Participants are recruited via email through online panel companies
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No treatment given
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Current medication burden
Time Frame: At the time of survey response (Day1)
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Numerical; Multiple select from defined list
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At the time of survey response (Day1)
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Injection perceptions
Time Frame: At the time of survey response (Day1)
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Likert scale for measurement of agreement from 1 "strongly disagree" to 7 "strongly agree"
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At the time of survey response (Day1)
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Attitudes regarding T2D overall
Time Frame: At the time of survey response (Day1)
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Likert scale for measurement of agreement from 1 "strongly disagree" to 7 "strongly agree"
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At the time of survey response (Day1)
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Attitudes regarding T2D treatment
Time Frame: At the time of survey response (Day1)
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Likert scales for measurement of satisfaction from 1 "extremely unsatisfied" to 7 "extremely satisfied" and agreement from 1 "strongly disagree" to 7 "strongly agree"
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At the time of survey response (Day1)
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Attitudes regarding insulin icodec
Time Frame: At the time of survey response (Day1)
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Likert scales for measurement of likelihood from 0 "not at all likely" to 10" extremely likely" and agreement from 1 "strongly disagree" to 7 "strongly agree; Rank top 3 from defined list
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At the time of survey response (Day1)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 27, 2023
Primary Completion (Actual)
April 17, 2023
Study Completion (Actual)
April 17, 2023
Study Registration Dates
First Submitted
February 10, 2023
First Submitted That Met QC Criteria
February 10, 2023
First Posted (Actual)
February 21, 2023
Study Record Updates
Last Update Posted (Actual)
May 15, 2023
Last Update Submitted That Met QC Criteria
May 12, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAS-7687
- U1111-1286-0886 (Other Identifier: World Health Organization (WHO))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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