RecruitingPhase 3NCT07271251

A Research Study to See if Two Different Formulations of Oral Semaglutide Are Equally Safe and Effective in Reducing the Blood Sugar Level in Japanese People With Type 2 Diabetes

A Study Investigating Clinical Comparability of Two Formulations of Oral Semaglutide in Japanese Participants With Type 2 Diabetes

Sponsor

Novo Nordisk A/S

Enrollment

264 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes

Summary

The purpose of the study is to find out if the new tablet formulation oral semaglutide D is equally safe and effective as the approved oral semaglutide for treating Japanese people with type 2 diabetes. Participants will receive either oral semaglutide D (the treatment being tested) or oral semaglutide (the comparator); which treatment a participant gets is decided by chance. Oral semaglutide is an approved tablet (a treatment used as a comparator), while oral semaglutide D is described as the new tablet formulation being tested in this study. The study will last approximately 27 weeks.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different pill forms of semaglutide (a diabetes medication also known as Rybelsus) in Japanese adults with type 2 diabetes to see if they work equally well and are equally safe for controlling blood sugar levels. **You may be eligible if...** - You are Japanese - You are 18 or older - You have been diagnosed with type 2 diabetes - You are willing to follow the study procedures and visit schedule **You may NOT be eligible if...** - You are not Japanese - You have type 1 diabetes or another form of diabetes - You are currently taking semaglutide or a similar GLP-1 medication - You have severe kidney, liver, or heart problems - You are pregnant or breastfeeding - You have a personal or family history of medullary thyroid cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral semaglutide

Semaglutide will be administered orally once daily.

Locations(15)

Seino Internal Medicine Clinic_Internal medicine

Koriyama-shi, Fukushima, Fukushima, Japan, Japan

Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine

Chigasaki-shi, Kanagawa, Japan, Japan

Jinnouchi Hospital_Internal Medicine

Kumamoto, Kumamoto, Japan, Japan

Heiwadai Hospital_Internal Medicine

Miyazaki, Miyazaki, Japan

TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

Aichi, Japan

Tokuyama clinic_Diabetic internal medicine

Chiba, Japan

Futata Tetsuhiro Clinic Meinohama_Internal medicine

Fukuoka-shi, Fukuoka, Japan

Oodouri Diabetes, Internal medicine Clinic_Internal Medicine, Diabetes Internal Medicine

Hokkaido, Japan

Naka Kinen Clinic_Internal medicine

Ibaraki, Japan

Yokohama Minoru Clinic_Internal medicine

Kanagawa, Japan

Shonan Takai Clinic_Internal Medicine

Kanagawa, Japan

Soka Sugiura Internal Medicine Clinic

Soka-shi, Saitama, Japan

Oyama East Clinic_Internal Medicine

Tochigi, Japan

Tokyo-Eki Center-building Clinic_Internal Medicine

Tokyo, Japan

Kato Clinic of Internal Medicine_Internal Medicine

Tokyo, Japan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07271251

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