Clinical trial NCT06478550: A Research Study to Understand How People With Type 2 Diabetes Take Ozempic® and if the Ozempic®App Helps Them Stay on This Treatment
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-06-27
Enrollment: 304
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with type 2 diabetes.

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.


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.

Primary outcomes:
measure: Persistency of semaglutide s.c. treatment in PSS app with connectivity vs control arm (Yes/No) (HCP reported)
timeFrame: At Visit 2 (week 16)
Secondary outcomes:
measure: Time from first dose to discontinuation (HCP reported)
timeFrame: From Visit 1 (week 0) to Visit 2 (week 16)
measure: HCP prespecified maintenance dose achieved at V2 (week 16)
timeFrame: At visit 2 (week 16)
measure: Time to HCP prespecified maintenance dose (HCP reported)
timeFrame: From Visit 1 (week 0) to Visit 2 (week 16)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: University Hospital of Athens ATTIKON
state: Attica
city: Thessaloniki
country: Greece
facility: General Hospital Of Thessaloniki Papageorgiou
state: Nea Efkarpia
city: Goudi/Athens
country: Greece
facility: "Laiko" General Hospital of Athens
city: Larissa
country: Greece
facility: Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease
city: Piraeus
country: Greece
facility: Tzaneio General Hospital of Piraeus
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki 'G. Gennimatas
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: