Type 2 DiabetesNCT05737810
Attitudes and Unmet Needs Among Type 2 Diabetes Patients
An observational study of Type 2 Diabetes, run by Novo Nordisk A/S at 7 sites in 7 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- No treatment given
- How many people
- 700 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 27 Mar 2023to 17 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
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.
- Conditions
- Type 2 Diabetes
- Being tested
- No treatment given
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
No treatment given
| Study group | Role | What they receive |
|---|---|---|
| People with Type 2 Diabetes | Participants are recruited via email through online panel companies Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current medication burden
Numerical; Multiple select from defined list
Measured: At the time of survey response (Day1)
Injection perceptions
Likert scale for measurement of agreement from 1 "strongly disagree" to 7 "strongly agree"
Measured: At the time of survey response (Day1)
Attitudes regarding T2D overall
Likert scale for measurement of agreement from 1 "strongly disagree" to 7 "strongly agree"
Measured: At the time of survey response (Day1)
Attitudes regarding T2D treatment
Likert scales for measurement of satisfaction from 1 "extremely unsatisfied" to 7 "extremely satisfied" and agreement from 1 "strongly disagree" to 7 "strongly agree"
Measured: At the time of survey response (Day1)
Attitudes regarding insulin icodec
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
Measured: At the time of survey response (Day1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start27 Mar 2023
- Primary completion17 Apr 2023
- Study completion17 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737810
- Sponsor's protocol ID
- DAS-7687
- Other IDs
- U1111-1286-0886
- Status last verified
- May 2023
- First submitted
- 10 Feb 2023
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attitudes and Unmet Needs Among Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT05737810
- Acronym / sponsor ID
- DAS-7687
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 17 Apr 2023 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with Type 2 Diabetes | – | Other: No treatment givenParticipants are recruited via email through online panel companies |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment givenNo treatment given | Other | People with Type 2 Diabetes |
Primary outcome
Current medication burden
Time frame: At the time of survey response (Day1)
Numerical; Multiple select from defined list
Injection perceptions
Time frame: At the time of survey response (Day1)
Likert scale for measurement of agreement from 1 "strongly disagree" to 7 "strongly agree"
Attitudes regarding T2D overall
Time frame: At the time of survey response (Day1)
Likert scale for measurement of agreement from 1 "strongly disagree" to 7 "strongly agree"
Attitudes regarding T2D treatment
Time frame: At the time of survey response (Day1)
Likert scales for measurement of satisfaction from 1 "extremely unsatisfied" to 7 "extremely satisfied" and agreement from 1 "strongly disagree" to 7 "strongly agree"
Attitudes regarding insulin icodec
Time frame: At the time of survey response (Day1)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: Yes. "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Novo Nordisk A/S at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, France, India, Mexico, Saudi Arabia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Current medication burden (time frame: At the time of survey response (Day1)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.