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

NCT07271251 | Active Not Recruiting Phase 3

• 2 other identifiers: NN9924-8485U1111-1321-8272
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in glycated haemoglobin (HbA1c).

  Measured in percentage (%)-point.

  From baseline (week 0) to end of treatment (week 20)

Secondary Outcomes (2)

• Change in body weight

  From baseline (week 0) to end of treatment (week 20)

• Number of treatment emergent adverse events (TEAEs)

  From baseline (week 0) to end of study (week 25)

Study Arms (2)

Oral semaglutide D

EXPERIMENTAL

Participants will receive oral semaglutide D once daily.

Drug: Oral semaglutide

Oral semaglutide

EXPERIMENTAL

Participants will receive oral semaglutide once daily.

Drug: Oral semaglutide

Interventions

Oral semaglutide DRUG

Semaglutide will be administered orally once daily.

Oral semaglutide; Oral semaglutide D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Current participation (i.e., signed informed consent) in any other interventional clinical study.
• Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
• Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
• Previous or planned (during the study period) obesity treatment with surgery or a weight loss device.
• Anticipated initiation or change in concomitant medications for more than 14 consecutive days affecting weight or glucose metabolism.
• Use of any medication with unknown or unspecified content within 90 days before screening.
• Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
• Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
• History or presence of pancreatitis (acute or chronic).
• History of major surgical procedures involving the stomach potentially affecting absorption of study products or current presence of gastrointestinal implant.
• Myocardial infarction, stroke, transient ischaemic attack or hospitalization for unstable angina pectoris within 60 days before screening.
• Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (15)

Seino Internal Medicine Clinic_Internal medicine

Koriyama-shi, Fukushima, Fukushima, Japan, 963-8851, Japan

Location

Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine

Chigasaki-shi, Kanagawa, Japan, 253-0044, Japan

Location

Jinnouchi Hospital_Internal Medicine

Kumamoto, Kumamoto, Japan, 862-0976, Japan

Location

Heiwadai Hospital_Internal Medicine

Miyazaki, Miyazaki, 880-0034, Japan

Location

TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

Aichi, 468-0009, Japan

Location

Tokuyama clinic_Diabetic internal medicine

Chiba, 261-0004, Japan

Location

Futata Tetsuhiro Clinic Meinohama_Internal medicine

Fukuoka-shi, Fukuoka, 819-0006, Japan

Location

Oodouri Diabetes, Internal medicine Clinic_Internal Medicine, Diabetes Internal Medicine

Hokkaido, 060-0001, Japan

Location

Naka Kinen Clinic_Internal medicine

Ibaraki, 311-0113, Japan

Location

Yokohama Minoru Clinic_Internal medicine

Kanagawa, 232-0064, Japan

Location

Shonan Takai Clinic_Internal Medicine

Kanagawa, 247-0055, Japan

Location

Soka Sugiura Internal Medicine Clinic

Soka-shi, Saitama, 340-0015, Japan

Location

Oyama East Clinic_Internal Medicine

Tochigi, 323-0022, Japan

Location

Tokyo-Eki Center-building Clinic_Internal Medicine

Tokyo, 103-0027, Japan

Location

Kato Clinic of Internal Medicine_Internal Medicine

Tokyo, 125-0054, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 29, 2026
• Study Completion (Estimated): August 3, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

JP (15)