A Research Study to Understand How People With Type 2 Diabetes Take Ozempic® and if the Ozempic®App Helps Them Stay on This Treatment

Sponsor
Novo Nordisk A/S
Study ID
NCT06478550
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    Participants will be treated with commercially available semaglutide subcutaneously (s.c.) according to routine clinical practice and according to local label at the discretion of the Health Care Providers (HCP). The decision to initiate treatment with semaglutide s.c. is independent from the decision to include the participant in the study.

Study Details

This study looks at how participants with type 2 diabetes take Ozempic® and if the Ozempic® app helps participants to stay on this treatment. Participants will already be prescribed with Ozempic® by the study doctor. Participants may be asked to use a device called Mallya®, which participants must attach to their Ozempic® injection pen. Participants might also be asked to install an Ozempic® app on their mobile phone which supports the participants in the use of Ozempic®. At the beginning and at the end of this study, the participants will have to fill out some questionnaires about their diabetes treatment. Participants may also be chosen to participate in a voluntary non-mandatory interview after the study has ended. The total duration of study is approximately 10 months.

Key Dates

Start date
Jun 26, 2024
Status verified
Feb 2026
Primary completion
Apr 23, 2025
Completion
Apr 23, 2025

Study Design

Enrollment
304 participants (actual)

Arms

  • Arm: Patient Support Solution (PSS) app with connectivity to Mallya
    Participants will be treated with commercially available semaglutide subcutaneously (s.c.) according to routine clinical practice and local label at the discretion of the Health Care Providers (HCP) and receive PSS app with connectivity to Mallya device.
  • Arm: PSS app without connectivity to Mallya
    Participants will be treated with commercially available semaglutide s.c. according to routine clinical practice and local label at the discretion of the HCP and receive PSS app without connectivity to Mallya device.
  • Arm: Mallya
    Participants will be treated with commercially available semaglutide s.c. according to routine clinical practice and local label at the discretion of the HCP and use only Mallya device without PSS app.
  • Arm: No intervention (Control arm)
    Participants will be treated with commercially available semaglutide s.c. according to routine clinical practice and local label at the discretion of the HCP and will not receive PSS app or Mallya device.

Primary Outcome Measure

Persistency of semaglutide s.c. treatment in PSS app with connectivity vs control arm (Yes/No) (HCP reported) [ Time Frame: At Visit 2 (week 16) ]

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