A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Denmark, as Part of Local Clinical Practice (PIONEER REAL)

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Oral Semaglutide

Study type: Observational

Funder types: Industry

Identifiers

NCT04537637

U1111-1240-4198 (Other Identifier)

NN9924-4548

Details and patient eligibility

About

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor. Participants will be asked to complete some questionnaires about their diabetes treatment. Participants will complete these during their normally scheduled visits with the study doctor.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)
• Diagnosed with type 2 diabetes mellitus
• The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study
• Male or female, age above or equal to 18 years at the time of signing informed consent
• Available HbA1c value less than or equal to 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit'(V1) if in line with local clinical practice
• Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than or equal to 14 days

Exclusion criteria

• Previous participation in this study. Participation is defined as having given informed consent in this study
• Treatment with any investigational drug within 30 days prior to enrolment into the study
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Trial design

99 participants in 1 patient group

Patients with type 2 diabetes

Description:

Adult patients with type 2 diabetes and naïve to injectable glucose-lowering treatment.

Treatment:

Drug: Oral Semaglutide