Type 2 DiabetesNCT06517784
Insulin Initiation and Adherence Behaviours: a Cross Sectional Survey of Indian HCPs & Patients With Type 2 Diabetes
An observational study of Type 2 Diabetes, run by Novo Nordisk A/S at 1 site in India.
Trial summary
This is a cross-sectional study planned among patients with Type 2 Diabetes (T2D) and Health Care Providers (HCPs) who treat T2D patients. Study participants will be recruited through existing databases/panels to complete a 30-minute self-administered online survey. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- No treatment given
- How many people
- 752 participants
- Where
- 1 siteIndia
- Study dates
- 5 Jul 2024to 16 Aug 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: Patients with Type 2 Diabetes (T2D) and Health Care Providers (HCPs) who treat T2D patients
Who may be able to join
- For patients
- 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 to 18 years at the time of signing informed consent.
- Diagnosed with T2D
- Currently seeing an HCP for T2D
- Initiated on insulin within the past 12 months
Show all 17Show fewer
- Prescribed insulin on a permanent basis
- Currently taking insulin via a vial and syringe or insulin pen
- For HCP
- 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 to 18 years at the time of signing informed consent.
- Primary care physician (PCP) with degree in internal medicine or general medicine, diabetologist with degree in internal medicine or general medicine plus diploma in diabetology, or endocrinologist
- Has been in practice a minimum of 2 years
- Diabetologist/endocrinologist: treats at least 50 T2D patients per month
- PCP: treats at least 40 T2D patients per month
- Currently initiates T2D patients on insulin
- Treats 20 percent or more of T2D patients with insulin
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
Trial locations and contacts
1 site in 1 country.
About this study
This is a cross-sectional study planned among patients with Type 2 Diabetes (T2D) and Health Care Providers (HCPs) who treat T2D patients. Study participants will be recruited through existing databases/panels to complete a 30-minute self-administered online survey. The purpose of the study is to understand the insulinization barriers and the insulin adherence behaviours of both HCPs and patients.
- 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 |
|---|---|---|
| Patients | Patients with type 2 diabetes Receives: Other: No treatment given | |
| Health care providers | Health care providers who treat patients with type 2 diabetes Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
The barriers toward insulin initiation among HCPs & patients
Barriers to insulin initiation = Likert scale: 1=Strongly disagree, 5=Strongly agree
Measured: At time of data abstraction (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start5 Jul 2024
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
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
- 752 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
- NCT06517784
- Sponsor's protocol ID
- NN000-7941
- Other IDs
- U1111-1302-7518
- Status last verified
- Aug 2024
- First submitted
- 18 Jul 2024
- Last updated
- 28 Aug 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 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Initiation and Adherence Behaviours: a Cross Sectional Survey of Indian HCPs & Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06517784
- Acronym / sponsor ID
- NN000-7941
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 752 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 24 Jul 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.
This is a cross-sectional study planned among patients with Type 2 Diabetes (T2D) and Health Care Providers (HCPs) who treat T2D patients. Study participants will be recruited through existing databases/panels to complete a 30-minute self-administered online survey. The purpose of the study is to understand the insulinization barriers and the insulin adherence behaviours of both HCPs and patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: No treatment givenPatients with type 2 diabetes |
| Health care providers | – | Other: No treatment givenHealth care providers who treat patients with type 2 diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Type 2 Diabetes (T2D) and Health Care Providers (HCPs) who treat T2D patients
Key inclusion criteria (17 listed)
- For patients
- 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 to 18 years at the time of signing informed consent.
- Diagnosed with T2D
- Currently seeing an HCP for T2D
Key exclusion criteria (2 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
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 | Health care providers, Patients |
Primary outcome
The barriers toward insulin initiation among HCPs & patients
Time frame: At time of data abstraction (Day 1)
Barriers to insulin initiation = Likert scale: 1=Strongly disagree, 5=Strongly agree
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 28 Aug 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, run by Novo Nordisk A/S at 1 site in India.
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 17 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 28 Aug 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 India. 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?
The barriers toward insulin initiation among HCPs & patients (time frame: At time of data abstraction (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 28 Aug 2024.