NCT07271251CompletedPhase 3
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
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 267 (actual)
- First submitted
- 27 Nov 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 29 Jun 2026
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- NCT number
- NCT07271251
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 267
- From 1 Dec 2025 to the primary completion date, 29 Jun 2026
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in this study. Participation is defined as signed informed consent.
- Previous or planned (during the study period) obesity treatment with surgery or a weight loss device.
- Use of any medication with unknown or unspecified content within 90 days before screening.
- Myocardial infarction, stroke, transient ischaemic attack or hospitalization for unstable angina pectoris within 60 days before screening.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified within 90 days before screening or in the period between screening and randomisation.
- 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.
- Any episodes of diabetic ketoacidosis within 90 days before screening.
Other illness
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
- 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 of major surgical procedures involving the stomach potentially affecting absorption of study products or current presence of gastrointestinal implant.
- Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.
- Presence or history of malignant neoplasms or in situ carcinomas within 5 years before screening.
Lab values
- Anticipated initiation or change in concomitant medications for more than 14 consecutive days affecting weight or glucose metabolism.
- 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.
Other
- 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.
- History or presence of pancreatitis (acute or chronic).
- Planned coronary, carotid or peripheral artery revascularisation.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology Coordinator of this site? Confirm its status | Aichi | Japan | Unknown status |
| Tokuyama clinic_Diabetic internal medicine Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine Coordinator of this site? Confirm its status | Chigasaki-shi | Japan | Unknown status |
| Futata Tetsuhiro Clinic Meinohama_Internal medicine Coordinator of this site? Confirm its status | Fukuoka-shi, Fukuoka | Japan | Unknown status |
| Oodouri Diabetes, Internal medicine Clinic_Internal Medicine, Diabetes Internal Medicine Coordinator of this site? Confirm its status | Hokkaido | Japan | Unknown status |
| Naka Kinen Clinic_Internal medicine Coordinator of this site? Confirm its status | Ibaraki | Japan | Unknown status |
| Yokohama Minoru Clinic_Internal medicine Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| Shonan Takai Clinic_Internal Medicine Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| Seino Internal Medicine Clinic_Internal medicine Coordinator of this site? Confirm its status | Koriyama-shi, Fukushima | Japan | Unknown status |
| Jinnouchi Hospital_Internal Medicine Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Heiwadai Hospital_Internal Medicine Coordinator of this site? Confirm its status | Miyazaki | Japan | Unknown status |
| Soka Sugiura Internal Medicine Clinic Coordinator of this site? Confirm its status | Soka-shi, Saitama | Japan | Unknown status |
| Oyama East Clinic_Internal Medicine Coordinator of this site? Confirm its status | Tochigi | Japan | Unknown status |
| Kato Clinic of Internal Medicine_Internal Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Tokyo-Eki Center-building Clinic_Internal Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.