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
- Diseases
- Type 2 diabetes
- 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
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale Pesenti Fenaroli Coordinator of this site? Confirm its status | Alzano Lombardo | Italy | Unknown status |
| INRCA Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| A.O.U. Policlinico S.Orsola Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Ospedale centrale L. Bohler Coordinator of this site? Confirm its status | Bolzano | Italy | Unknown status |
| ASL Caserta Coordinator of this site? Confirm its status | Caserta | Italy | Unknown status |
| Azienda Ospedaliera "Cannizzaro" Coordinator of this site? Confirm its status | Catania | Italy | Unknown status |
| Azienda Sanitaria Locale Cn1 Coordinator of this site? Confirm its status | Cuneo | Italy | Unknown status |
| Università degli Studi Foggia Coordinator of this site? Confirm its status | Foggia | Italy | Unknown status |
| Ospedale Misericordia Coordinator of this site? Confirm its status | Grosseto | Italy | Unknown status |
| Asl Lecce Coordinator of this site? Confirm its status | Lecce | Italy | Unknown status |
| Ospedale Pagliari Coordinator of this site? Confirm its status | Massafra | Italy | Unknown status |
| ASL Avellino Coordinator of this site? Confirm its status | Montoro | Italy | Unknown status |
| ASL Napoli 3 sud Coordinator of this site? Confirm its status | Palma Campania | Italy | Unknown status |
| A.O.U. Maggiore della Carità Coordinator of this site? Confirm its status | Piemonte | Italy | Unknown status |
| Ospedale San Jacopo Coordinator of this site? Confirm its status | Pistoia | Italy | Unknown status |
| P.O. Praia a Mare Coordinator of this site? Confirm its status | Praia a Mare | Italy | Unknown status |
| Ospedale Generale Provinciale Coordinator of this site? Confirm its status | Province of Macerata | Italy | Unknown status |
| ASL Roma 2 - UOC Cure Primarie Distretto 4 Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Fondazione Univ. Policlinico A.Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| ASL Al Di Alessandria - Ospedale Santo Spirito - Casale Monferrato - Cardiologia Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| A.O.U. Policlinico Giaccone Coordinator of this site? Confirm its status | Sicilia | Italy | Unknown status |
| Casa di cure Triolo Zancla Coordinator of this site? Confirm its status | Sicilia | Italy | Unknown status |
| Ospedale Treviglio Coordinator of this site? Confirm its status | Treviglio | Italy | Unknown status |
| Ospedale S. Maria Della Misericordia Coordinator of this site? Confirm its status | Udine | Italy | Unknown status |
| ASST Sette Laghi Coordinator of this site? Confirm its status | Varese | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.