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)

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: Active, not recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Semaglutide

• Study Type: Observational
• Enrollment (Estimated): 390

Contacts and Locations

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
    • ASL Cuneo 1
  • Foggia, Italy, 71122
    • Università degli Studi Foggia
  • Grosseto, Italy, 58100
    • Ospedale Misericordia
  • Macerata, Italy, 62100
    • Ospedale Generale provinciale
  • Massafra, Italy, 74016
    • Ospedale Pagliari
  • Montoro, Italy, 83026
    • ASL Avellino
  • Nardò, Italy, 73048
    • ASL Lecce
  • Palma Campania, Italy, 80036
    • ASL Napoli 3 sud
  • Piemonte, Italy, 28100
    • A.O.U. Maggiore della Carità
  • 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
    • Casa della Salute ASL RM2
  • Roma, Italy, 00195
    • Ospedale Santo Spirito
  • 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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in body weight	Measured in percentage (%).	From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks)
Absolute change in body weight	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)	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	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)	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%	Measured as number of participants (yes or no).	At end of study (week 40 ± 4 weeks)
Number of participants with HbA1c <6.5%	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%	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%	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	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)	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)	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

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Glucagon-Like Peptide-1 Receptor Agonists; Semaglutide
• Other Study ID 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