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

NCT ID: NCT06478550

Last Updated: 2026-02-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 304 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-26
• Study Completion Date: 2025-04-23

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Semaglutide

Intervention Type: 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.

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.

Semaglutide

Intervention Type: 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.

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.

Semaglutide

Intervention Type: 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.

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.

Semaglutide

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Ozempic®

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

University Hospital of Athens ATTIKON

Athens, Attica, Greece

General Hospital Of Thessaloniki Papageorgiou

Thessaloniki, Nea Efkarpia, Greece

"Laiko" General Hospital of Athens

Goudi/Athens, , Greece

Univ Gen Hospital Larisa

Larissa, , Greece

Geniko Nosokomeio Peiraia Tzaneio

Piraeus, , Greece

General Hospital of Thessaloniki 'G. Gennimatas

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

U1111-1286-4221

Identifier Type: OTHER

Identifier Source: secondary_id

NN9535-5029

Identifier Type: -

Identifier Source: org_study_id