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
NCT ID: NCT07271251
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
264 participants
INTERVENTIONAL
2025-12-01
2026-08-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oral semaglutide D
Participants will receive oral semaglutide D once daily.
Oral semaglutide
Semaglutide will be administered orally once daily.
Oral semaglutide
Participants will receive oral semaglutide once daily.
Oral semaglutide
Semaglutide will be administered orally once daily.
Interventions
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Oral semaglutide
Semaglutide will be administered orally once daily.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency dept. 2834
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Seino Internal Medicine Clinic_Internal medicine
Koriyama-shi, Fukushima, Fukushima, Japan, Japan
Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine
Chigasaki-shi, Kanagawa, Japan, Japan
Jinnouchi Hospital_Internal Medicine
Kumamoto, Kumamoto, Japan, Japan
Heiwadai Hospital_Internal Medicine
Miyazaki, Miyazaki, Japan
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
Aichi, , Japan
Tokuyama clinic_Diabetic internal medicine
Chiba, , Japan
Futata Tetsuhiro Clinic Meinohama_Internal medicine
Fukuoka-shi, Fukuoka, , Japan
Oodouri Diabetes, Internal medicine Clinic_Internal Medicine, Diabetes Internal Medicine
Hokkaido, , Japan
Naka Kinen Clinic_Internal medicine
Ibaraki, , Japan
Yokohama Minoru Clinic_Internal medicine
Kanagawa, , Japan
Shonan Takai Clinic_Internal Medicine
Kanagawa, , Japan
Soka Sugiura Internal Medicine Clinic
Soka-shi, Saitama, , Japan
Oyama East Clinic_Internal Medicine
Tochigi, , Japan
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, , Japan
Kato Clinic of Internal Medicine_Internal Medicine
Tokyo, , Japan
Countries
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Central Contacts
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Other Identifiers
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U1111-1321-8272
Identifier Type: OTHER
Identifier Source: secondary_id
NN9924-8485
Identifier Type: -
Identifier Source: org_study_id
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