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

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Semaglutide

Study type: Observational

Funder types: Industry

Identifiers

NCT06478550

U1111-1286-4221 (Other Identifier)

NN9535-5029

Details and patient eligibility

About

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.

Enrollment: 304 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

304 participants in 4 patient groups

Patient Support Solution (PSS) app with connectivity to Mallya

Description:

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.

Treatment:

Drug: Semaglutide

PSS app without connectivity to Mallya

Description:

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.

Treatment:

Drug: Semaglutide

Mallya

Description:

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.

Treatment:

Drug: Semaglutide

No intervention (Control arm)

Description:

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.

Treatment:

Drug: Semaglutide