DOORS

Completed

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

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

291

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≥7.5%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05755360

Org study IDNN9924-7508

Secondary IDU1111-1274-4674World Health Organization (WHO)

Timeline

Milestones

Study start2023-02-21actual

Study first posted2023-03-06actual

Primary completion2024-10-21actual

Study completion2024-10-21actual

Last update posted2025-10-02actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

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

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)

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

Patient-reported / QoL

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Relative change in body weight

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute change in body weight

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

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Absolute change in waist circumference

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

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

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)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

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)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

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

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of participants with HbA1c <6.5%

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

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

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)

HbA1c, change

threshold achievement, improvement

componentsHbA1c, change, ≥5% weight-loss responders

LOINC 4548-4

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

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)

change from baseline, improvement

Secondary/protocol endpoint

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)

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

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)

change from baseline, improvement

Secondary/protocol endpoint

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)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

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)

Severe hypoglycemia

categorical status, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

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)

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.