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A Research Study to Understand How Oral Semaglutide Works in People With Type 2 Diabetes in India | Clinical Trials | Clareo Health

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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

NCT05502562•Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Key Dates

Start Date

February 24, 2023

Primary Completion Date

June 3, 2024

Completion Date

June 3, 2024

Last Updated

September 19, 2024

Enrollment

388

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

Oral semaglutide

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes

Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use

Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes

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