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Completed
A Research Study to Understand How People With Type 2 Diabetes Take Ozempic® and if the Ozempic®App Helps Them Stay on This Treatment
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
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Study population
Type 2 diabetes
Primary endpoint
•Persistency of semaglutide s.c. treatment in PSS app with connectivity
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
NCT IDNCT06478550
Org study IDNN9535-5029
Secondary IDU1111-1286-4221World Health Organization (WHO)
Study start2024-06-26actual
Study first posted2024-06-27actual
Primary completion2025-04-23actual
Study completion2025-04-23actual
Last update posted2026-02-11actual
Assets
Investigational agents
Study populations
Who this study enrolls
Type 2 diabetes
Eligibility
Who can enroll
Minimum age25 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample
Study population text
Participants with type 2 diabetes.
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.
Endpoints (4)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Safety / tolerability / PK2 Safety / tolerability / PK
2 endpointsSecondary/protocol endpoint
Time from first dose to discontinuation (HCP reported)
Time frame:From Visit 1 (week 0) to Visit 2 (week 16)
Discontinuation due to AE
time to event, event
Secondary/protocol endpoint
HCP prespecified maintenance dose achieved at V2 (week 16)
Time frame:At visit 2 (week 16)
threshold achievement, descriptive
Other clinical outcomes
1 endpointPrimary/protocol endpoint
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)
categorical status, improvement
Other (unclassified)
1 endpointSecondary/protocol endpoint/low confidence
Time to HCP prespecified maintenance dose (HCP reported)
Time frame:From Visit 1 (week 0) to Visit 2 (week 16)
time to event, descriptive
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.
