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

Novo Nordisk A/S25 sites in 1 country291 target enrollmentFebruary 21, 2023

ConditionsDiabetes Mellitus, Type 2

InterventionsSemaglutide

DrugsSemaglutide

Overview

Phase: Not Applicable
Intervention: Semaglutide
Conditions: Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Enrollment: 291
Locations: 25
Primary Endpoint: Absolute change in glycated haemoglobin (HbA1c) (millimoles per mole [mmol/mol])
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 21, 2023

End Date

October 21, 2024

Last Updated

7 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

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)

Arms & Interventions

Participants with T2D

Participants will be treated with commercially available oral semaglutide according to routine clinical practice at the discretion of the treating physician.

Intervention: Semaglutide

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

Absolute change in body weight(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%(From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks))
Relative 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))
Number of participants with HbA1c <6.5%(At end of study (week 40 ± 4 weeks))
Absolute change in diabetes distress survey (DDS) scores (points)(From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks))
Number of participants with HbA1c less than (<) 7%(At end of study (week 40 ± 4 weeks))
Absolute change in dutch eating behaviour questionnaire (DEBQ) scores (points)(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 >= 5%(From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks))
Self-reported severe hypoglycaemia during the study period(From informed consent and treatment initiation (week 0) to end of study (week 40 ± 4 weeks))