Type-2 Diabetes Mellitus (T2DM)DCENCT06592950
Patient Preference Study in Type-2 Diabetes Mellitus: Discrete Choice Experiment (DCE) to Support Novo Nordisk's Long-Acting Insulin
An observational study of Type-2 Diabetes Mellitus (T2DM), run by Novo Nordisk A/S at 1 site in Denmark.
Trial summary
The primary objective of this research is to assess T2DM patient preferences for a once weekly insulin treatment. The study involves a qualitative interview phase and quantitative survey phase with a Discrete Choice Experiment (DCE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type-2 Diabetes Mellitus (T2DM)
- What is being tested?
- No treatment given
- How many people
- 513 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Nov 2023to 29 Apr 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type-2 diabetes mellitus (T2DM) patients
Who may be able to join
- Patient is an adult aged 18 years or over
- Patient was diagnosed with type-2 diabetes mellitus (T2DM) greater than or equal to 180 days prior to the day of screening
- Patient is currently prescribed a diabetes treatment (e.g., Metformin/Sus, DPP4i, SGLT2i, GLP-1 RA and/or basal insulin)
- Patient is willing and able to provide written informed consent to participate
- For qualitative interviews:
- Patient is a fluent speaker of English and is able to read, write, and fully understand the English language
Show all 10Show fewer
- Patient is a resident in Canada
- For quantitative online survey:
- Patient is a fluent speaker of the local language (English/French/Spanish or Japanese) and is able to read, write and fully understand the local language
- Patient is a resident of either Canada, France, Spain or Japan
Who cannot join
- Patient is currently employing a basal-bolus insulin treatment regimen to manage their diabetes
- Patient is unwilling or unable to comply with the needs of the study or has a physical, behavioural or mental condition that, in the opinion of the recruiter may affect the patient's ability to take part in the study, understand the nature, scope and possible consequences of the study, or the responses they might provide.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this research is to assess T2DM patient preferences for a once weekly insulin treatment. The study involves a qualitative interview phase and quantitative survey phase with a Discrete Choice Experiment (DCE).
- Conditions
- Type-2 Diabetes Mellitus (T2DM)
- Being tested
- No treatment given
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
Online survey
No treatment givenOther
Interviews
| Study group | Role | What they receive |
|---|---|---|
| Quantitative online survey | Across four markets (Canada, France, Spain and Japan) Receives: Other: No treatment given | |
| Qualitative interviews | Conducted in Canada Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
T2DM patient preferences for a once weekly insulin treatment
Pre-defined open-ended questions and Discrete Choice Experiment online survey
Measured: Day of interview/survey completion (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 Nov 2023
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type-2 Diabetes Mellitus (T2DM)Studies 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
- Prospective
- Enrolment
- 513 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
- NCT06592950
- Sponsor's protocol ID
- DAS-7791
- Other IDs
- U1111-1293-3919
- Acronym
- DCE
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Preference Study in Type-2 Diabetes Mellitus: Discrete Choice Experiment (DCE) to Support Novo Nordisk's Long-Acting Insulin
- ClinicalTrials.gov ID
- NCT06592950
- Acronym / sponsor ID
- DCE / DAS-7791
- Conditions
- Type-2 Diabetes Mellitus (T2DM)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 19 Sep 2024 (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 primary objective of this research is to assess T2DM patient preferences for a once weekly insulin treatment. The study involves a qualitative interview phase and quantitative survey phase with a Discrete Choice Experiment (DCE).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quantitative online survey | – | Other: No treatment givenAcross four markets (Canada, France, Spain and Japan) |
| Qualitative interviews | – | Other: No treatment givenConducted in Canada |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type-2 diabetes mellitus (T2DM) patients
Key inclusion criteria (10 listed)
- Patient is an adult aged 18 years or over
- Patient was diagnosed with type-2 diabetes mellitus (T2DM) greater than or equal to 180 days prior to the day of screening
- Patient is currently prescribed a diabetes treatment (e.g., Metformin/Sus, DPP4i, SGLT2i, GLP-1 RA and/or basal insulin)
- Patient is willing and able to provide written informed consent to participate
- Patient is a fluent speaker of English and is able to read, write, and fully understand the English language
Key exclusion criteria (2 listed)
- Patient is currently employing a basal-bolus insulin treatment regimen to manage their diabetes
- Patient is unwilling or unable to comply with the needs of the study or has a physical, behavioural or mental condition that, in the opinion of the recruiter may affect the patient's ability to take part in the study, understand the nature, scope and possible consequences of the study, or the responses they might provide.
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 givenOnline survey | Other | Quantitative online survey |
| No treatment givenInterviews | Other | Qualitative interviews |
Primary outcome
T2DM patient preferences for a once weekly insulin treatment
Time frame: Day of interview/survey completion (Day 1)
Pre-defined open-ended questions and Discrete Choice Experiment online survey
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 19 Sep 2024.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type-2 Diabetes Mellitus (T2DM), run by Novo Nordisk A/S at 1 site in Denmark.
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 10 inclusion and 2 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
T2DM patient preferences for a once weekly insulin treatment (time frame: Day of interview/survey completion (Day 1)). 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 19 Sep 2024.