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 (DOORS)

October 1, 2025 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
291

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alzano Lombardo, Italy, 24022
        • Ospedale Pesenti Fenaroli
      • Ancona, Italy, 60127
        • INRCA
      • Bologna, Italy, 40138
        • A.O.U. Policlinico S.Orsola
      • Bolzano, Italy, 39100
        • Ospedale centrale L. Bohler
      • Caserta, Italy, 81100
        • Asl Caserta
      • Catania, Italy, 95126
        • Azienda Ospedaliera Cannizzaro
      • Cuneo, Italy, 12100
        • Azienda Sanitaria Locale Cn1
      • Foggia, Italy, 71122
        • Università degli Studi Foggia
      • Grosseto, Italy, 58100
        • Ospedale Misericordia
      • Lecce, Italy, 73100
        • Asl Lecce
      • Macerata, Italy, 62100
        • Ospedale Generale provinciale
      • Massafra, Italy, 74016
        • Ospedale Pagliari
      • Montoro, Italy, 83026
        • ASL Avellino
      • Palma Campania, Italy, 80036
        • Asl Napoli 3 Sud
      • Piemonte, Italy, 28100
        • A.O.U. Maggiore della Carita
      • Pistoia, Italy, 51100
        • Ospedale San Jacopo
      • Praia a Mare, Italy, 87028
        • P.O. Praia a Mare
      • Roma, Italy, 00168
        • Fondazione Univ. Policlinico A.Gemelli
      • Roma, Italy, 00159
        • ASL Roma 2 - UOC Cure Primarie Distretto 4
      • Roma, Italy, 00195
        • ASL Al Di Alessandria - Ospedale Santo Spirito - Casale Monferrato - Cardiologia
      • Sicilia, Italy, 90127
        • A.O.U. Policlinico Giaccone
      • Sicilia, Italy, 90133
        • Casa di cure Triolo Zancla
      • Treviglio, Italy, 24047
        • Ospedale Treviglio
      • Udine, Italy, 33100
        • Ospedale S. Maria Della Misericordia
      • Varese, Italy, 21100
        • ASST Sette Laghi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants with T2D
Participants will be treated with commercially available oral semaglutide according to routine clinical practice at the discretion of the treating physician.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Measured in %-point.
From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Absolute change in glycated haemoglobin (HbA1c) (millimoles per mole [mmol/mol])
Time Frame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Measured in mmol/mol.
From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relative change in body weight
Time Frame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Measured in percentage (%).
From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Absolute change in body weight
Time Frame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Measured in Kilograms (kg).
From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Absolute change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDLc], high density lipoprotein cholesterol [HDLc], triglycerides)
Time Frame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Measured in millimoles per liter (mmol/L).
From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Absolute change in waist circumference
Time Frame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Measured in centimeters (cm).
From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Absolute change in blood pressure (systolic and diastolic)
Time Frame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Measured in millimeters of mercury (mmHg).
From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Number of participants with HbA1c less than (<) 7%
Time Frame: At end of study (week 40 ± 4 weeks)
Measured as number of participants (yes or no).
At end of study (week 40 ± 4 weeks)
Number of participants with HbA1c <6.5%
Time Frame: At end of study (week 40 ± 4 weeks)
Measured as number of participants (yes or no).
At end of study (week 40 ± 4 weeks)
HbA1c reduction greater than or equal to (>=) 1%-point and body weight reduction of >= 5%
Time Frame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Measured as number of participants (yes or no).
From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
HbA1c reduction greater than or equal to (>=) 1%-point and body weight reduction of >= 3%
Time Frame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Measured as number of participants (yes or no).
From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Self-reported severe hypoglycaemia during the study period
Time Frame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Measured as number of participants (yes or no).
From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Absolute change in dutch eating behaviour questionnaire (DEBQ) scores (points)
Time Frame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
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.
From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Absolute change in diabetes distress survey (DDS) scores (points)
Time Frame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
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.
From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 21, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 21, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9924-7508
  • U1111-1274-4674 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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