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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Oral semaglutide

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan, 468-0009
    • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
  • Chiba, Japan, 261-0004
    • Tokuyama clinic_Diabetic internal medicine
  • Fukuoka-shi, Fukuoka, Japan, 819-0006
    • Futata Tetsuhiro Clinic Meinohama_Internal medicine
  • Hokkaido, Japan, 060-0001
    • Oodouri Diabetes, Internal medicine Clinic_Internal Medicine, Diabetes Internal Medicine
  • Ibaraki, Japan, 311-0113
    • Naka Kinen Clinic_Internal medicine
  • Kanagawa, Japan, 247-0055
    • Shonan Takai Clinic_Internal Medicine
  • Kanagawa, Japan, 232-0064
    • Yokohama Minoru Clinic_Internal medicine
  • Soka-shi, Saitama, Japan, 340-0015
    • Soka Sugiura Internal Medicine Clinic
  • Tochigi, Japan, 323-0022
    • Oyama East Clinic_Internal Medicine
  • Tokyo, Japan, 103-0027
    • Tokyo-Eki Center-building Clinic_Internal Medicine
  • Tokyo, Japan, 125-0054
    • Kato Clinic of Internal Medicine_Internal Medicine
  • Fukushima, Japan
    • Koriyama-shi, Fukushima, Fukushima, Japan, Japan, 963-8851
      • Seino Internal Medicine Clinic_Internal medicine
  • Kanagawa, Japan
    • Chigasaki-shi, Kanagawa, Japan, Japan, 253-0044
      • Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine
  • Kumamoto, Japan
    • Kumamoto, Kumamoto, Japan, Japan, 862-0976
      • Jinnouchi Hospital_Internal Medicine
  • Miyazaki
    • Miyazaki, Miyazaki, Japan, 880-0034
      • Heiwadai Hospital_Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Planned coronary, carotid or peripheral artery revascularisation.
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified within 90 days before screening or in the period between screening and randomisation.
• Impaired liver function, defined as Alanine Aminotransferase (ALT) ≥ 2.5 times or Bilirubin >1.5 times upper normal limit at screening.
• Renal impairment with estimated glomerular filtration rate (eGFR) less than (<) 30 millilitres per minute per meter square (mL/min/1.73 m^2) as per 2021 Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) formula (by creatinine) at screening.
• Treatment with medication for diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
• Presence or history of malignant neoplasms or in situ carcinomas within 5 years before screening.
• Any episodes of diabetic ketoacidosis within 90 days before screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral semaglutide D; Participants will receive oral semaglutide D once daily.	Drug: Oral semaglutide; Semaglutide will be administered orally once daily.
Experimental: Oral semaglutide; Participants will receive oral semaglutide once daily.	Drug: Oral semaglutide; Semaglutide will be administered orally once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glycated haemoglobin (HbA1c).	Measured in percentage (%)-point.	From baseline (week 0) to end of treatment (week 20)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Measured in Kilogram (Kg).	From baseline (week 0) to end of treatment (week 20)
Number of treatment emergent adverse events (TEAEs)	Measured as count of events.	From baseline (week 0) to end of study (week 25)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): June 29, 2026
• Study Completion (Estimated): August 3, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 9, 2025

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; semaglutide
• Other Study ID Numbers: NN9924-8485; U1111-1321-8272 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No