Diabetes Mellitus, Type 2NCT06478550
A Research Study to Understand How People With Type 2 Diabetes Take Ozempic® and if the Ozempic®App Helps Them Stay on This Treatment
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 6 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- How many people
- 304 participants
- Where
- 6 sitesGreece
- Study dates
- 26 Jun 2024to 23 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with type 2 diabetes.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
Greece6 sites
University Hospital of Athens ATTIKON
Athens, Attica, 12462
"Laiko" General Hospital of Athens
Goudi/Athens, 11527
Univ Gen Hospital Larisa
Larissa, 41110
Geniko Nosokomeio Peiraia Tzaneio
Piraeus, 18536
General Hospital Of Thessaloniki Papageorgiou
Thessaloniki, Nea Efkarpia, 56429
General Hospital of Thessaloniki 'G. Gennimatas
Thessaloniki, 54635
About this study
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
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
- Being tested
- Semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called Ozempic®
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Semaglutide | |
| 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. Receives: Drug: Semaglutide | |
| 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. Receives: Drug: Semaglutide | |
| 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. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistency of semaglutide s.c. treatment in PSS app with connectivity vs control arm (Yes/No) (HCP reported)
Measured as number of participants (Yes/No).
Measured: At Visit 2 (week 16)
Secondary outcomes (3)
Time from first dose to discontinuation (HCP reported)
Measured in days.
Measured: From Visit 1 (week 0) to Visit 2 (week 16)
HCP prespecified maintenance dose achieved at V2 (week 16)
Measured as number of participants (Yes/No).
Measured: At visit 2 (week 16)
Time to HCP prespecified maintenance dose (HCP reported)
Measured in days.
Measured: From Visit 1 (week 0) to Visit 2 (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start26 Jun 2024
- Primary completion23 Apr 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478550
- Sponsor's protocol ID
- NN9535-5029
- Other IDs
- U1111-1286-4221
- Status last verified
- Feb 2026
- First submitted
- 24 Jun 2024
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06478550
- Acronym / sponsor ID
- NN9535-5029
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient Support Solution (PSS) app with connectivity to Mallya | – | Drug: SemaglutideParticipants 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. |
| PSS app without connectivity to Mallya | – | Drug: SemaglutideParticipants 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. |
| Mallya | – | Drug: SemaglutideParticipants 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. |
| No intervention (Control arm) | – | Drug: SemaglutideParticipants 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with type 2 diabetes.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideAlso: Ozempic®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. | Drug | Mallya, No intervention (Control arm), PSS app without connectivity to Mallya, Patient Support Solution (PSS) app with connectivity to Mallya |
Primary outcome
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).
3 secondary outcomes
Time from first dose to discontinuation (HCP reported)
Time frame: 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)
Time to HCP prespecified maintenance dose (HCP reported)
Time frame: From Visit 1 (week 0) to Visit 2 (week 16)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 6 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.