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

February 9, 2026 updated by: Novo Nordisk A/S

A Pilot Study Investigating the Effect of Patient Support Solution App With Connectivity on Once-weekly Semaglutide s.c. Treatment Persistence in Patients With Type 2 Diabetes in a Clinical Practice Setting

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

304

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Goudi/Athens, Greece, 11527
        • "Laiko" General Hospital of Athens
      • Larissa, Greece, 41110
        • Univ Gen Hospital Larisa
      • Piraeus, Greece, 18536
        • Geniko Nosokomeio Peiraia Tzaneio
      • Thessaloniki, Greece, 54635
        • General Hospital of Thessaloniki 'G. Gennimatas
    • Attica
      • Athens, Attica, Greece, 12462
        • University Hospital of Athens ATTIKON
    • Nea Efkarpia
      • Thessaloniki, Nea Efkarpia, Greece, 56429
        • General Hospital Of Thessaloniki Papageorgiou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with type 2 diabetes.

Description

Inclusion Criteria:

  • Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  • The decision to initiate treatment with commercially available semaglutide s.c. has been made by the patient and the Health Care Providers (HCP) and independently from the decision to include the patient in this study. Patients can be randomised up to 10 days after being prescribed semaglutide.
  • Treatment with semaglutide s.c. is needed for intensification of glycaemic control and used according to label as judged by HCP.
  • Male or female; aged 25-75 years (both inclusive) at the time of signing informed consent.
  • Diagnosed with type 2 diabetes (T2D) at least 180 days prior to obtaining informed consent.
  • Willing to comply with the protocol requirements which includes use of Patient Support Solution (PSS) app on own mobile device (iphone Operating System (iOS) 11 (or higher) and Android 4.1 (or higher) devices), using Mallya®, filling out questionnaires as judged by the HCP.

Exclusion Criteria:

  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Treatment with any investigational drug within 30 days prior to enrolment into the study.
  • Glucagon Like Peptide-1 Receptor Agonist (GLP-1 RA) use for 90 days prior to randomisation. However, one prescription of once-weekly semaglutide subcutaneously (s.c.) is allowed up to 10 days prior to randomisation.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  • Use of pacemaker or body worn infusion pumps according to Mallya®'s instruction for use.
  • Impaired eyesight prohibiting readability of PSS app provided on mobile device.
  • Inability to independently self-manage anti-diabetic treatments received as judged by HCP.
  • Inability to independently inject semaglutide s.c. treatment as judged by HCP.
  • Inability to fulfil study requirement as judged by the HCP.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Semaglutide
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.
Other Names:
  • Ozempic®
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.
Drug: Semaglutide
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.
Other Names:
  • Ozempic®
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.
Drug: Semaglutide
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.
Other Names:
  • Ozempic®
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.
Drug: Semaglutide
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.
Other Names:
  • Ozempic®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Measured as number of participants (Yes/No).
At Visit 2 (week 16)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from first dose to discontinuation (HCP reported)
Time Frame: From Visit 1 (week 0) to Visit 2 (week 16)
Measured in days.
From Visit 1 (week 0) to Visit 2 (week 16)
HCP prespecified maintenance dose achieved at V2 (week 16)
Time Frame: At visit 2 (week 16)
Measured as number of participants (Yes/No).
At visit 2 (week 16)
Time to HCP prespecified maintenance dose (HCP reported)
Time Frame: From Visit 1 (week 0) to Visit 2 (week 16)
Measured in days.
From Visit 1 (week 0) to Visit 2 (week 16)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2024

Primary Completion (Actual)

April 23, 2025

Study Completion (Actual)

April 23, 2025

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9535-5029
  • U1111-1286-4221 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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