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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1286-4221 | Other Identifier | World Health Organization (WHO) |
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This study looks at how participants with type 2 diabetes take OzempicĀ® and if the OzempicĀ® app helps participants to stay on this treatment. Participants will already be prescribed with OzempicĀ® by the study doctor. Participants may be asked to use a device called MallyaĀ®, which participants must attach to their OzempicĀ® injection pen. Participants might also be asked to install an OzempicĀ® app on their mobile phone which supports the participants in the use of OzempicĀ®. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At Visit 2 (week 16) |
| Measure | Description | Time Frame |
|---|---|---|
| Time from first dose to discontinuation (HCP reported) | Measured in days. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with type 2 diabetes.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Athens ATTIKON | Athens | Attica | 12462 | Greece | ||
| General Hospital Of Thessaloniki Papageorgiou |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| At visit 2 (week 16) |
| Time to HCP prespecified maintenance dose (HCP reported) | Measured in days. | From Visit 1 (week 0) to Visit 2 (week 16) |
| Thessaloniki |
| Nea Efkarpia |
| 56429 |
| Greece |
| "Laiko" General Hospital of Athens | Goudi/Athens | 11527 | Greece |
| Univ Gen Hospital Larisa | Larissa | 41110 | Greece |
| Geniko Nosokomeio Peiraia Tzaneio | Piraeus | 18536 | Greece |
| General Hospital of Thessaloniki 'G. Gennimatas | Thessaloniki | 54635 | Greece |
| D004700 | Endocrine System Diseases |