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NCT05755360Completed

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

A Multicentre, Prospective, Non-Interventional, Single-Arm Study Investigating Glycaemic Control and Patient-Reported Outcomes in Type 2 Diabetes Patients, Uncontrolled on DPP4i Treatment and Who Switch to Oral Semaglutide in a Real-World Setting in Italy

Source: ClinicalTrials.gov · Last updated 2 Oct 2025

Brief summary (registry, in English)

The purpose of the study is to look at the change in blood sugar levels in people with type 2 diabetes who change their treatment from DPP4i to oral semaglutide. Participant will get oral semaglutide as prescribed by the study doctor. The study will last for about 5-6 months. Participants will be asked to complete two questionnaires. One will be about eating behaviour and the other one will be diabetes related. Participant will complete this questionnaire during the normal scheduled visit with study doctor. Participants will be asked questions about their health and diabetes treatment and lab tests as part of their normal doctor's appointment.

Status (registry)
Completed
Study type
Observational
Enrollment
291 (actual)
First submitted
23 Feb 2023
Start date
21 Feb 2023
Primary completion date
21 Oct 2024
Lead sponsor
Novo Nordisk A/S
NCT number
NCT05755360

What you commit to

  • Study type: Observational
  • Participants enrolled: 291
  • From 21 Feb 2023 to the primary completion date, 21 Oct 2024
  • 25 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous participation in this study. Participation is defined as having given informed consent in this study
  • 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

Other illness

  • Participants with type-1 diabetes

Age

  • Age \< 18 years on the informed consent and treatment initiation visit (V1)

Other

  • 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.

Who the study is looking for

  • 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 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ospedale Pesenti Fenaroli
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Alzano LombardoItalyUnknown status
INRCA
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AnconaItalyUnknown status
A.O.U. Policlinico S.Orsola
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BolognaItalyUnknown status
Ospedale centrale L. Bohler
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BolzanoItalyUnknown status
ASL Caserta
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CasertaItalyUnknown status
Azienda Ospedaliera "Cannizzaro"
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CataniaItalyUnknown status
Azienda Sanitaria Locale Cn1
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CuneoItalyUnknown status
Università degli Studi Foggia
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FoggiaItalyUnknown status
Ospedale Misericordia
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GrossetoItalyUnknown status
Asl Lecce
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LecceItalyUnknown status
Ospedale Pagliari
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MassafraItalyUnknown status
ASL Avellino
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MontoroItalyUnknown status
ASL Napoli 3 sud
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Palma CampaniaItalyUnknown status
A.O.U. Maggiore della Carità
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PiemonteItalyUnknown status
Ospedale San Jacopo
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PistoiaItalyUnknown status
P.O. Praia a Mare
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Praia a MareItalyUnknown status
Ospedale Generale Provinciale
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Province of MacerataItalyUnknown status
ASL Roma 2 - UOC Cure Primarie Distretto 4
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RomaItalyUnknown status
Fondazione Univ. Policlinico A.Gemelli
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RomaItalyUnknown status
ASL Al Di Alessandria - Ospedale Santo Spirito - Casale Monferrato - Cardiologia
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RomaItalyUnknown status
A.O.U. Policlinico Giaccone
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SiciliaItalyUnknown status
Casa di cure Triolo Zancla
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SiciliaItalyUnknown status
Ospedale Treviglio
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TreviglioItalyUnknown status
Ospedale S. Maria Della Misericordia
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UdineItalyUnknown status
ASST Sette Laghi
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VareseItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.