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

August 12, 2026 updated by: Novo Nordisk A/S

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
267

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in glycated haemoglobin (HbA1c).
Time Frame: From baseline (week 0) to end of treatment (week 20)
Measured in percentage (%)-point.
From baseline (week 0) to end of treatment (week 20)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: From baseline (week 0) to end of treatment (week 20)
Measured in Kilogram (Kg).
From baseline (week 0) to end of treatment (week 20)
Number of treatment emergent adverse events (TEAEs)
Time Frame: From baseline (week 0) to end of study (week 25)
Measured as count of events.
From baseline (week 0) to end of study (week 25)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 4, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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