A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Italy, as Part of Local Clinical Practice
NCT ID: NCT04094415
Last Updated: 2023-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
581 participants
OBSERVATIONAL
2019-10-28
2021-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Semaglutide
Participants will receive semaglutide at the treating physician's discretion as part of the usual clinical practice. The prescription and use of semaglutide is completely independent of this study. Total study duration for the individual patient will be approximately 30 weeks.
Semaglutide
Patients will be treated with commercially available semaglutide in a prefilled pen injector (FlexTouch® variant) according to routine local clinical practice at the discretion of the treating physician. Other anti-hyperglycaemic treatments will be prescribed at the physician's discretion.The decision to initiate treatment with semaglutide is at the treating physician's discretion, and clearly separated from the decision to include the patient in the study.
Interventions
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Semaglutide
Patients will be treated with commercially available semaglutide in a prefilled pen injector (FlexTouch® variant) according to routine local clinical practice at the discretion of the treating physician. Other anti-hyperglycaemic treatments will be prescribed at the physician's discretion.The decision to initiate treatment with semaglutide is at the treating physician's discretion, and clearly separated from the decision to include the patient in the study.
Eligibility Criteria
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Inclusion Criteria
* The decision to initiate treatment with commercially available semaglutide has been made by the patient/Legally Acceptable Representative and the treating physician before and independently from the decision to include the patient in this study
* Male or female, age 18 years or older at the time of signing informed consent
* Diagnosed with type 2 diabetes at least 12 weeks prior to inclusion
* Available and documented haemoglobin A1c (HbA1c) value equal to or less than 12 weeks prior to initiation of semaglutide treatment
Exclusion Criteria
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Treatment with any investigational drug within 90 days prior to enrolment into the study
* Hypersensitivity to semaglutide or to any of the excipients
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Reporting Anchor and Disclosure (1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Bagno a Ripoli, , Italy
Novo Nordisk Investigational Site
Bari, , Italy
Novo Nordisk Investigational Site
Bergamo, , Italy
Novo Nordisk Investigational Site
Bergamo, , Italy
Novo Nordisk Investigational Site
Bologna, , Italy
Novo Nordisk Investigational Site
Brindisi, , Italy
Novo Nordisk Investigational Site
Casarano (Lecce), , Italy
Novo Nordisk Investigational Site
Catanzaro, , Italy
Novo Nordisk Investigational Site
Chieri Torino, , Italy
Novo Nordisk Investigational Site
Cipolleto Perugia, , Italy
Novo Nordisk Investigational Site
Foggia, , Italy
Novo Nordisk Investigational Site
Gaeta, , Italy
Novo Nordisk Investigational Site
Genova, , Italy
Novo Nordisk Investigational Site
Livorno, , Italy
Novo Nordisk Investigational Site
L’Aquila, , Italy
Novo Nordisk Investigational Site
Macerata, , Italy
Novo Nordisk Investigational Site
Milan, , Italy
Novo Nordisk Investigational Site
Milan, , Italy
Novo Nordisk Investigational Site
Milan, , Italy
Novo Nordisk Investigational Site
Napoli, , Italy
Novo Nordisk Investigational Site
Napoli, , Italy
Novo Nordisk Investigational Site
Napoli, , Italy
Novo Nordisk Investigational Site
Napoli, , Italy
Novo Nordisk Investigational Site
Negrar (VR), , Italy
Novo Nordisk Investigational Site
Orbassano, , Italy
Novo Nordisk Investigational Site
Pavia, , Italy
Novo Nordisk Investigational Site
Prato, , Italy
Novo Nordisk Investigational Site
Ravenna, , Italy
Novo Nordisk Investigational Site
Roma, , Italy
Novo Nordisk Investigational Site
Roma, , Italy
Novo Nordisk Investigational Site
Rome, , Italy
Novo Nordisk Investigational Site
Rozzano (MI), , Italy
Novo Nordisk Investigational Site
Sesto San Giovanni (MI), , Italy
Novo Nordisk Investigational Site
Treviglio (Bergamo), , Italy
Novo Nordisk Investigational Site
Treviso, , Italy
Novo Nordisk Investigational Site
Udine, , Italy
Novo Nordisk Investigational Site
Vicenza, , Italy
Novo Nordisk Investigational Site
Vicenza, , Italy
Novo Nordisk Investigational Site
Vigevano, , Italy
Countries
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References
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Napoli R, Berra C, Catarig AM, Di Loreto C, Donatiello E, Berentzen TL, Pitocco D, Giorgino F. Once-weekly semaglutide use in patients with type 2 diabetes: Real-world data from the SURE Italy observational study. Diabetes Obes Metab. 2023 Jun;25(6):1658-1667. doi: 10.1111/dom.15020. Epub 2023 Mar 12.
Other Identifiers
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U1111-1233-2023
Identifier Type: OTHER
Identifier Source: secondary_id
NN9535-4549
Identifier Type: -
Identifier Source: org_study_id
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