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

NCT05755360 | Completed

• 2 other identifiers: NN9924-7508U1111-1274-4674
• Study Type: observational
• Target: 291
• Locations: 1 country
• Sites: 25

Brief 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. 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

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

  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])

  Measured in mmol/mol.

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

Secondary Outcomes (12)

• Relative change in body weight

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

• Absolute change in body weight

  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)

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

• Absolute change in waist circumference

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

• Absolute change in blood pressure (systolic and diastolic)

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

Study Arms (1)

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

Interventions

Semaglutide DRUG

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.

Participants with T2D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (25)

Ospedale Pesenti Fenaroli

Alzano Lombardo, 24022, Italy

Location

INRCA

Ancona, 60127, Italy

Location

A.O.U. Policlinico S.Orsola

Bologna, 40138, Italy

Location

Ospedale centrale L. Bohler

Bolzano, 39100, Italy

Location

ASL Caserta

Caserta, 81100, Italy

Location

Azienda Ospedaliera Cannizzaro

Catania, 95126, Italy

Location

Azienda Sanitaria Locale Cn1

Cuneo, 12100, Italy

Location

Università degli Studi Foggia

Foggia, 71122, Italy

Location

Ospedale Misericordia

Grosseto, 58100, Italy

Location

ASL Lecce

Lecce, 73100, Italy

Location

Ospedale Generale provinciale

Macerata, 62100, Italy

Location

Ospedale Pagliari

Massafra, 74016, Italy

Location

ASL Avellino

Montoro, 83026, Italy

Location

ASL Napoli 3 sud

Palma Campania, 80036, Italy

Location

A.O.U. Maggiore della Carità

Piemonte, 28100, Italy

Location

Ospedale San Jacopo

Pistoia, 51100, Italy

Location

P.O. Praia a Mare

Praia a Mare, 87028, Italy

Location

ASL Roma 2 - UOC Cure Primarie Distretto 4

Roma, 00159, Italy

Location

Fondazione Univ. Policlinico A.Gemelli

Roma, 00168, Italy

Location

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

Roma, 00195, Italy

Location

A.O.U. Policlinico Giaccone

Sicilia, 90127, Italy

Location

Casa di cure Triolo Zancla

Sicilia, 90133, Italy

Location

Ospedale Treviglio

Treviglio, 24047, Italy

Location

Ospedale S. Maria della Misericordia

Udine, 33100, Italy

Location

ASST Sette Laghi

Varese, 21100, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 6, 2023
• Study Start: February 21, 2023
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

IT (25)