A Research Study to Understand How Oral Semaglutide Works in People With Type 2 Diabetes in India (PIONEER REAL)

Novo Nordisk

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Oral semaglutide

Study type

Observational

Funder types

Industry

Identifiers

NCT05502562

U1111-1270-0826 (Other Identifier)

NN9924-4960

Details and patient eligibility

About

The purpose of the study is to look at the change in blood sugar levels in participants with type 2 diabetes who start using oral semaglutide. Participants will get oral semaglutide as prescribed to them by the study doctor. The study will last for about 8-11 months (34-44 weeks). Participants will be asked to complete a questionnaire about how they take oral semaglutide tablets. Participants will complete this questionnaire during the normal scheduled visit with the doctor and will be asked questions about their health and their diabetes treatment and lab tests as part of their normal doctor's appointment.

Enrollment

388 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 (T2D).
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 glycated haemoglobin A1c (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 naive 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.
Any prior or current use of oral semaglutide.
Hypersensitivity to oral semaglutide or to any of the excipients.
Treatment with any investigational drug within 30 days prior to signing of informed consent.
Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to signing of informed consent.
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.