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

What Was Tested

This registered phase 3 trial tested Semaglutide.

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.

It had two arms (groups): Oral semaglutide D (experimental) and Oral semaglutide (experimental).

Participants will receive oral semaglutide D once daily.

Participants will receive oral semaglutide once daily.

The registry classes the interventions as drug.

Who Took Part

267 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: known or suspected hypersensitivity to study intervention(s) or related products; previous participation in this study. participation is defined as signed informed consent; female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-12-01 with completion listed for 2026-06-29.

It ran at 15 sites in Japan (15).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in glycated haemoglobin (HbA1c) (time frame: From baseline (week 0) to end of treatment (week 20)).

It also tracked 2 secondary outcomes, for example Change in body weight and Number of treatment emergent adverse events (TEAEs).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 267 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.