NCT05502562Completed
A Research Study to Understand How Oral Semaglutide Works in People With Type 2 Diabetes in India
A Multicentre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Initiation of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in India
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 388 (actual)
- First submitted
- 14 Aug 2022
- Start date
- 24 Feb 2023
- Primary completion date
- 3 Jun 2024
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- NCT number
- NCT05502562
What you commit to
- Study type: Observational
- Participants enrolled: 388
- From 24 Feb 2023 to the primary completion date, 3 Jun 2024
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Any prior or current use of oral semaglutide.
- 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.
Other illness
- Hypersensitivity to oral semaglutide or to any of the excipients.
Other
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Related publications
- Real-World Usage of Once-Daily Oral Semaglutide in Adults with Type 2 Diabetes: Findings from PIONEER REAL India.Indian J Endocrinol Metab · 2025 · PMID 41229720
This page is information, not medical advice. Discuss any trial with your doctor.