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

Sponsor
Novo Nordisk A/S
Study ID
NCT07271251
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 1, 2025
Status verified
Mar 2026
Primary completion
Jun 29, 2026
Completion
Aug 3, 2026

Study Design

Enrollment
264 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oral semaglutide D
    Participants will receive oral semaglutide D once daily.
  • Experimental: Oral semaglutide
    Participants will receive oral semaglutide once daily.

Primary Outcome Measure

Change in glycated haemoglobin (HbA1c). [ Time Frame: From baseline (week 0) to end of treatment (week 20) ]

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