NCT06592950

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
513

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

September 9, 2024

Last Update Submit

September 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • T2DM patient preferences for a once weekly insulin treatment

    Pre-defined open-ended questions and Discrete Choice Experiment online survey

    Day of interview/survey completion (Day 1)

Study Arms (2)

Quantitative online survey

Across four markets (Canada, France, Spain and Japan)

Other: No treatment given

Qualitative interviews

Conducted in Canada

Other: No treatment given

Interventions

Online survey

Quantitative online survey

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type-2 diabetes mellitus (T2DM) patients

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk

Søborg, 2860, Denmark

Location

Study Officials

  • Clinical Transparency dept. 2834

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 19, 2024

Study Start

November 2, 2023

Primary Completion

April 29, 2024

Study Completion

April 29, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

More information

Locations