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

NCT ID: NCT05502562

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 388 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-24
• Study Completion Date: 2024-06-03

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with type 2 diabetes

Adult participants with type 2 diabetes and naive to injectable glucose-lowering treatment.

Oral semaglutide

Intervention Type: DRUG

Participants will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. 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 participant in this study.

Interventions

Oral semaglutide

Participants will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. 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 participant in this study.

Intervention Type: DRUG

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).
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency dept. 2834

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Other Identifiers

U1111-1270-0826

Identifier Type: OTHER

Identifier Source: secondary_id

NN9924-4960

Identifier Type: -

Identifier Source: org_study_id