New diabetes pill shows promise in japanese trial
NCT ID NCT07271251
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This study tests whether a new tablet formulation of semaglutide (oral semaglutide D) works as well as the approved version in Japanese adults with type 2 diabetes. About 264 participants will take either the new or approved tablet once daily for 27 weeks. Researchers will compare changes in blood sugar levels and body weight, and monitor side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- oral semaglutide (a diabetes medication taken as a tablet once daily)
- What this could lead to
- If successful, this could show that the new tablet formulation works as well as the approved version, offering an alternative for managing type 2 diabetes.
- What could go wrong
- This is a small, short-term study in Japanese participants only, so results may not apply to other groups. The new formulation might not prove equally effective or safe.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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267 people
The number who actually took part.
- Started
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Dec 2025
- Finished
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Aug 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Futata Tetsuhiro Clinic Meinohama_Internal medicine
Fukuoka-shi, Fukuoka, 819-0006, Japan
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Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine
Chigasaki-shi, Kanagawa, Japan, 253-0044, Japan
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Heiwadai Hospital_Internal Medicine
Miyazaki, Miyazaki, 880-0034, Japan
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Jinnouchi Hospital_Internal Medicine
Kumamoto, Kumamoto, Japan, 862-0976, Japan
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Kato Clinic of Internal Medicine_Internal Medicine
Tokyo, 125-0054, Japan
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Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113, Japan
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Oodouri Diabetes, Internal medicine Clinic_Internal Medicine, Diabetes Internal Medicine
Hokkaido, 060-0001, Japan
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Oyama East Clinic_Internal Medicine
Tochigi, 323-0022, Japan
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Seino Internal Medicine Clinic_Internal medicine
Koriyama-shi, Fukushima, Fukushima, Japan, 963-8851, Japan
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Shonan Takai Clinic_Internal Medicine
Kanagawa, 247-0055, Japan
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Soka Sugiura Internal Medicine Clinic
Soka-shi, Saitama, 340-0015, Japan
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TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
Aichi, 468-0009, Japan
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Tokuyama clinic_Diabetic internal medicine
Chiba, 261-0004, Japan
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Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, 103-0027, Japan
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Yokohama Minoru Clinic_Internal medicine
Kanagawa, 232-0064, Japan
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