Clinical trial

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

Name

NN9924-7508

Description

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.

Trial arms

Trial start

2023-02-21

Estimated PCD

2024-10-31

Trial end

2024-10-31

Status

Active (not recruiting)

Treatment

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.

Arms:

Participants with T2D

Size

390

Primary endpoint

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

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

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)

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 390, 'type': 'ESTIMATED'}}

Updated at

2024-03-20

1 organization

1 product

2 indications

Product

Indication

Indication

Organization