Clinical trial NCT05755360: 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
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-03-06
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Absolute change in glycated haemoglobin (HbA1c) (percentage [%]-point)
timeFrame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
measure: Absolute change in glycated haemoglobin (HbA1c) (millimoles per mole [mmol/mol])
timeFrame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Secondary outcomes:
measure: Relative change in body weight
timeFrame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
measure: Absolute change in body weight
timeFrame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
measure: Absolute change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDLc], high density lipoprotein cholesterol [HDLc], triglycerides)
timeFrame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
measure: Absolute change in waist circumference
timeFrame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
measure: Absolute change in blood pressure (systolic and diastolic)
timeFrame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
measure: Number of participants with HbA1c less than (<) 7%
timeFrame: At end of study (week 40 ± 4 weeks)
measure: Number of participants with HbA1c <6.5%
timeFrame: At end of study (week 40 ± 4 weeks)
measure: HbA1c reduction greater than or equal to (>=) 1%-point and body weight reduction of >= 5%
timeFrame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
measure: HbA1c reduction greater than or equal to (>=) 1%-point and body weight reduction of >= 3%
timeFrame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
measure: Self-reported severe hypoglycaemia during the study period
timeFrame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
measure: Absolute change in dutch eating behaviour questionnaire (DEBQ) scores (points)
timeFrame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
measure: Absolute change in diabetes distress survey (DDS) scores (points)
timeFrame: From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Other outcomes:
Locations:
city: Alzano Lombardo
country: Italy
facility: Ospedale Pesenti Fenaroli
city: Ancona
country: Italy
facility: INRCA
city: Bologna
country: Italy
facility: A.O.U. Policlinico S.Orsola
city: Bolzano
country: Italy
facility: Ospedale centrale L. Bohler
city: Caserta
country: Italy
facility: ASL Caserta
city: Catania
country: Italy
facility: Azienda Ospedaliera Cannizzaro
city: Cuneo
country: Italy
facility: ASL Cuneo 1
city: Foggia
country: Italy
facility: Università degli Studi Foggia
city: Grosseto
country: Italy
facility: Ospedale Misericordia
city: Macerata
country: Italy
facility: Ospedale Generale provinciale
city: Massafra
country: Italy
facility: Ospedale Pagliari
city: Montoro
country: Italy
facility: ASL Avellino
city: Nardò
country: Italy
facility: ASL Lecce
city: Palma Campania
country: Italy
facility: ASL Napoli 3 sud
city: Piemonte
country: Italy
facility: A.O.U. Maggiore della Carità
city: Pistoia
country: Italy
facility: Ospedale San Jacopo
city: Praia a Mare
country: Italy
facility: P.O. Praia a Mare
city: Roma
country: Italy
facility: Casa della Salute ASL RM2
city: Roma
country: Italy
facility: Fondazione Univ. Policlinico A.Gemelli
city: Roma
country: Italy
facility: Ospedale Santo Spirito
city: Sicilia
country: Italy
facility: A.O.U. Policlinico Giaccone
city: Sicilia
country: Italy
facility: Casa di cure Triolo Zancla
city: Treviglio
country: Italy
facility: Ospedale Treviglio
city: Udine
country: Italy
facility: Ospedale S. Maria della Misericordia
city: Varese
country: Italy
facility: ASST Sette Laghi
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: