A Study Investigating Clinical Comparability of Two Formulations of Oral Semaglutide in Japanese Participants With Type 2 Diabetes
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.
• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
• Japanese male or female.
• Age 18 years or above at the time of signing the informed consent.
• Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 90 days prior to day of screening.
• Glycated haemoglobin (HbA1c) of 7.0-10.5 percent (%) (53-91 millimoles per mole \[mmol /mol\]) (both inclusive) at screening.
• Stable daily dose(s) ≥ 60 days before screening with any 1-2 of the following oral antidiabetic drugs (OADs): Sulfonylurea (SU), glinide, thiazolidinedione (TZD), alpha-glucosidase inhibitor (α-GI), sodium-glucose cotransporter 2 (SGLT-2) inhibitor or metformin (effective or maximum tolerated dose as judged by the investigator) according to Japanese labelling.