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

A study investigating clinical comparability of two formulations of oral semaglutide in Japanese participants with type 2 diabetes(NN9924-8485)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250491

Enrollment

264

Registered

2025-11-10

Start date

2025-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

This is an interventional, multi-centre, randomised, open-label, phase 3 study, designed to confirm non-inferiority of change from baseline in HbA1c to week 20 of oral semaglutide D 4 mg to oral semag

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. HbA1c of 7.0-10.5 % (53-91 mmol /mol) (both inclusive) at screening. 2. Stable daily dose(s) >= 60 days before screening with any 1-2 of the following OADs: SU, glinide, TZD, alpha-GI, SGLT-2 inhibitor or metformin (effective or maximum tolerated dose as judged by the investigator) according to Japanese labelling.

Exclusion criteria

Exclusion criteria: Previous or planned (during the study period) obesity treatment with surgery or a weight loss device.

Design outcomes

Primary

Measure	Time frame
Change From baseline to end of treatment in HbA1c (%)	—

Contacts

Public Contactperson in charge of registering clinical trial inf

Novo Nordisk Pharma Ltd.

JPHC_clinical_trials@novonordisk.com+81-3-6266-1000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026