DOORS: A Research Study to Understand How Oral Semaglutide Works in People With Type 2 Diabetes Who Change From Dipeptidyl Peptidase-4 Inhibitor (DPP4i) Treatment to Oral Semaglutide in Italy
NCT ID: NCT05755360
Last Updated: 2025-10-02
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
291 participants
OBSERVATIONAL
2023-02-21
2024-10-21
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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Participants with T2D
Participants will be treated with commercially available oral semaglutide according to routine clinical practice at the discretion of the treating physician.
Semaglutide
Participants will be treated with commercially available oral semaglutide according to routine clinical practice at the discretion of the treating physician. The decision to switch from DPP4i treatment to oral semaglutide is at the discretion of the treating physician and is clearly independent from the decision to include the participant in the study.
Interventions
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Semaglutide
Participants will be treated with commercially available oral semaglutide according to routine clinical practice at the discretion of the treating physician. The decision to switch from DPP4i treatment to oral semaglutide is at the discretion of the treating physician and is clearly independent from the decision to include the participant in the study.
Eligibility Criteria
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Inclusion Criteria
* The decision to switch from DPP4i treatment to commercially available oral semaglutide has been made by the participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the participant in this study
* Participant with last measurement of HbA1c \>= 7.5% at informed consent and treatment initiation visit (V1) or less than or equal to (\<=) 90 days before informed consent and treatment initiation visit (V1)
* Treatment naïve to insulin. An exception is short-term insulin treatment for acute illness for a total of \< 14 days
Exclusion Criteria
* Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to the informed consent and treatment initiation visit (V1) and throughout the duration of the study
* Participants with type-1 diabetes
* Participants who are pregnant or who become pregnant (or who plan to become pregnant) during the study period
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Age \< 18 years on the informed consent and treatment initiation visit (V1)
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 Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Ospedale Pesenti Fenaroli
Alzano Lombardo, , Italy
INRCA
Ancona, , Italy
A.O.U. Policlinico S.Orsola
Bologna, , Italy
Ospedale centrale L. Bohler
Bolzano, , Italy
ASL Caserta
Caserta, , Italy
Azienda Ospedaliera Cannizzaro
Catania, , Italy
Azienda Sanitaria Locale Cn1
Cuneo, , Italy
Università degli Studi Foggia
Foggia, , Italy
Ospedale Misericordia
Grosseto, , Italy
ASL Lecce
Lecce, , Italy
Ospedale Generale provinciale
Macerata, , Italy
Ospedale Pagliari
Massafra, , Italy
ASL Avellino
Montoro, , Italy
ASL Napoli 3 sud
Palma Campania, , Italy
A.O.U. Maggiore della Carità
Piemonte, , Italy
Ospedale San Jacopo
Pistoia, , Italy
P.O. Praia a Mare
Praia a Mare, , Italy
ASL Roma 2 - UOC Cure Primarie Distretto 4
Roma, , Italy
Fondazione Univ. Policlinico A.Gemelli
Roma, , Italy
ASL Al Di Alessandria - Ospedale Santo Spirito - Casale Monferrato - Cardiologia
Roma, , Italy
A.O.U. Policlinico Giaccone
Sicilia, , Italy
Casa di cure Triolo Zancla
Sicilia, , Italy
Ospedale Treviglio
Treviglio, , Italy
Ospedale S. Maria della Misericordia
Udine, , Italy
ASST Sette Laghi
Varese, , Italy
Countries
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Other Identifiers
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U1111-1274-4674
Identifier Type: OTHER
Identifier Source: secondary_id
NN9924-7508
Identifier Type: -
Identifier Source: org_study_id
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