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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
264
Semaglutide will be administered orally once daily.
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
...and 5 more locations
Change in glycated haemoglobin (HbA1c).
Measured in percentage (%)-point.
Time frame: From baseline (week 0) to end of treatment (week 20)
Change in body weight
Measured in Kilogram (Kg).
Time frame: From baseline (week 0) to end of treatment (week 20)
Number of treatment emergent adverse events (TEAEs)
Measured as count of events.
Time frame: From baseline (week 0) to end of study (week 25)
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