経口セマグルチドの2種類の異なる製剤が、日本人2型糖尿病患者の血糖値を下げるのに同等の安全性と有効性があるかどうかを検証する研究

基本情報

NCT ID: NCT07271251
ステータス: 募集中
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 264
治験依頼者名: Novo Nordisk A/S

概要

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.

対象疾患

Type 2 Diabetes

介入

Oral semaglutide(DRUG)

依頼者（Sponsor）

ノボノルディスクファーマ株式会社(INDUSTRY)

実施施設 (15)

医療法人社団湘美会　湘南高井内科

Kanagawa, Japan(RECRUITING)

Seino Internal Medicine Clinic_Internal medicine

Koriyama-shi, Fukushima, Fukushima, Japan, Japan(RECRUITING)

Heiwadai Hospital_Internal Medicine

Miyazaki, Miyazaki, Japan(RECRUITING)

Tokyo-Eki Center-building Clinic_Internal Medicine

Tokyo, Japan(RECRUITING)

すぎうら糖尿病内科クリニック

Soka-shi, Saitama, Japan(RECRUITING)

陣内病院

Kumamoto, Kumamoto, Japan, Japan(RECRUITING)

医療法人　二田哲博クリニック姪浜

Fukuoka-shi, Fukuoka, Japan(RECRUITING)

医療法人社団新東会横浜みのるクリニック

Kanagawa, Japan(RECRUITING)

Oodouri Diabetes, Internal medicine Clinic_Internal Medicine, Diabetes Internal Medicine

Hokkaido, Japan(RECRUITING)

糖尿病・内分泌内科クリニックＴＯＳＡＫＩ

Aichi, Japan(RECRUITING)

小山イーストクリニック

Tochigi, Japan(RECRUITING)

かとう泌尿器科・内科・外科クリニック

Tokyo, Japan(RECRUITING)

林眼科病院付属林内科クリニック

Chigasaki-shi, Kanagawa, Japan, Japan(RECRUITING)

さくらい循環器・内科クリニック

Chiba, Japan(RECRUITING)

Naka Kinen Clinic_Internal medicine

Ibaraki, Japan(RECRUITING)