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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05737810




Registration number
NCT05737810
Ethics application status
Date submitted
10/02/2023
Date registered
21/02/2023
Date last updated
15/05/2023

Titles & IDs
Public title
Attitudes and Unmet Needs Among Type 2 Diabetes Patients
Scientific title
Attitudes and Unmet Needs Among Type 2 Diabetes Patients
Secondary ID [1] 0 0
U1111-1286-0886
Secondary ID [2] 0 0
DAS-7687
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No treatment given

People with Type 2 Diabetes - Participants are recruited via email through online panel companies


Other interventions: No treatment given
No treatment given
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Current medication burden
Timepoint [1] 0 0
At the time of survey response (Day1)
Primary outcome [2] 0 0
Injection perceptions
Timepoint [2] 0 0
At the time of survey response (Day1)
Primary outcome [3] 0 0
Attitudes regarding T2D overall
Timepoint [3] 0 0
At the time of survey response (Day1)
Primary outcome [4] 0 0
Attitudes regarding T2D treatment
Timepoint [4] 0 0
At the time of survey response (Day1)
Primary outcome [5] 0 0
Attitudes regarding insulin icodec
Timepoint [5] 0 0
At the time of survey response (Day1)

Eligibility
Key inclusion criteria
1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, age above or equal between 18 to 65 years at the time of signing informed consent.
3. Diagnosed with T2D and currently treating T2D with at least one medication
4. Insulin user that is not using insulin pump
5. Lives in a target country
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
3. Does not meet inclusion criteria requirements

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/04/2023
Sample size
Target
Accrual to date
Final
700
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Chartres
Country [2] 0 0
India
State/province [2] 0 0
Bengaluru
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Seoul
Country [4] 0 0
Mexico
State/province [4] 0 0
Mexico City
Country [5] 0 0
Saudi Arabia
State/province [5] 0 0
Riyadh
Country [6] 0 0
United Kingdom
State/province [6] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 being managed with insulin therapy overall. Study participants will be recruited to complete a 15-minute self-administered online survey.
Trial website
https://clinicaltrials.gov/study/NCT05737810
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 2834)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05737810