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Diabetes Mellitus, Type 2DOORSNCT05755360

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

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 25 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Semaglutide
Type of treatment
Pill or oral medicine
How many people
291 participants
Where
25 sitesItaly
Study dates
21 Feb 2023to 21 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All Participants who switch from DPP4i treatment to oral semaglutide and meet the eligibility criteria will be included in the study.

Who may be able to join

  • 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

Who cannot join

  • 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
  • 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)

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Italy25 sites

  • Ospedale Pesenti Fenaroli

    Alzano Lombardo, 24022

  • INRCA

    Ancona, 60127

  • A.O.U. Policlinico S.Orsola

    Bologna, 40138

  • Ospedale centrale L. Bohler

    Bolzano, 39100

  • ASL Caserta

    Caserta, 81100

  • Azienda Ospedaliera Cannizzaro

    Catania, 95126

  • Azienda Sanitaria Locale Cn1

    Cuneo, 12100

  • Università degli Studi Foggia

    Foggia, 71122

  • Ospedale Misericordia

    Grosseto, 58100

  • ASL Lecce

    Lecce, 73100

  • Ospedale Pagliari

    Massafra, 74016

  • ASL Avellino

    Montoro, 83026

  • ASL Napoli 3 sud

    Palma Campania, 80036

  • A.O.U. Maggiore della Carità

    Piemonte, 28100

  • Ospedale San Jacopo

    Pistoia, 51100

  • P.O. Praia a Mare

    Praia a Mare, 87028

  • Ospedale Generale provinciale

    Province of Macerata, 62100

  • ASL Roma 2 - UOC Cure Primarie Distretto 4

    Roma, 00159

  • Fondazione Univ. Policlinico A.Gemelli

    Roma, 00168

  • ASL Al Di Alessandria - Ospedale Santo Spirito - Casale Monferrato - Cardiologia

    Roma, 00195

  • A.O.U. Policlinico Giaccone

    Sicilia, 90127

  • Casa di cure Triolo Zancla

    Sicilia, 90133

  • Ospedale Treviglio

    Treviglio, 24047

  • Ospedale S. Maria della Misericordia

    Udine, 33100

  • ASST Sette Laghi

    Varese, 21100

Other trials in Italy

About this study

Official title: 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

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.

Being tested
Semaglutide
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    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.

Study groups in NCT05755360
Study groupRoleWhat they receive
Participants with T2DParticipants will be treated with commercially available oral semaglutide according to routine clinical practice at the discretion of the treating physician.
Receives: Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute change in glycated haemoglobin (HbA1c) (percentage [%]-point)

    Measured in %-point.

    Measured: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)

  2. Absolute change in glycated haemoglobin (HbA1c) (millimoles per mole [mmol/mol])

    Measured in mmol/mol.

    Measured: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)

Secondary outcomes (12)

  1. Relative change in body weight

    Measured in percentage (%).

    Measured: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)

  2. Absolute change in body weight

    Measured in Kilograms (kg).

    Measured: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)

  3. Absolute change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDLc], high density lipoprotein cholesterol [HDLc], triglycerides)

    Measured in millimoles per liter (mmol/L).

    Measured: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)

  4. Absolute change in waist circumference

    Measured in centimeters (cm).

    Measured: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)

  5. Absolute change in blood pressure (systolic and diastolic)

    Measured in millimeters of mercury (mmHg).

    Measured: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)

  6. Number of participants with HbA1c less than (<) 7%

    Measured as number of participants (yes or no).

    Measured: At end of study (week 40 ± 4 weeks)

  7. Number of participants with HbA1c <6.5%

    Measured as number of participants (yes or no).

    Measured: At end of study (week 40 ± 4 weeks)

  8. HbA1c reduction greater than or equal to (>=) 1%-point and body weight reduction of >= 5%

    Measured as number of participants (yes or no).

    Measured: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)

  9. HbA1c reduction greater than or equal to (>=) 1%-point and body weight reduction of >= 3%

    Measured as number of participants (yes or no).

    Measured: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)

  10. Self-reported severe hypoglycaemia during the study period

    Measured as number of participants (yes or no).

    Measured: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)

  11. Absolute change in dutch eating behaviour questionnaire (DEBQ) scores (points)

    DEBQ is a 33-item self-reported questionnaire to assess three distinct eating behaviours in adults: emotional eating, external eating, and restrained eating. For all 33 items participants will provide response in terms of: never, seldom, sometimes, often, very often. Absolute change in DEBQ (total score) calculated as the absolute difference between the DEBQ scores (total score) at baseline and post baseline measurements of DEBQ scores (total score) up to and including end of study visit.

    Measured: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)

  12. Absolute change in diabetes distress survey (DDS) scores (points)

    DDS is a self-administered 17-item scale that captures four critical dimensions of diabetes-related distress: emotional burden, regimen distress, interpersonal distress, and physician distress. Each item was scored in the range of 1 to 6: 1) not a problem; 2) a slight problem; 3) a moderate problem; 4) somewhat serious problem; 5) a serious problem; 6) a very serious problem. Participants will rate each item item indicating the degree to which each of the 17 items may have distressed or bothered them during the past month. High score indicated high distress.

    Measured: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2023
  2. Study start21 Feb 2023
  3. Primary completion21 Oct 2024
  4. Study completion21 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
291 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05755360
Sponsor's protocol ID
NN9924-7508
Other IDs
U1111-1274-4674
Acronym
DOORS
Status last verified
Sep 2025
First submitted
23 Feb 2023
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 25 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute change in glycated haemoglobin (HbA1c) (percentage [%]-point) (time frame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05755360.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.

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