Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT07271251
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 264}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2025-11-27', 'studyFirstSubmitQcDate': '2025-11-27', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in glycated haemoglobin (HbA1c).', 'timeFrame': 'From baseline (week 0) to end of treatment (week 20)', 'description': 'Measured in percentage (%)-point.'}], 'secondaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': 'From baseline (week 0) to end of treatment (week 20)', 'description': 'Measured in Kilogram (Kg).'}, {'measure': 'Number of treatment emergent adverse events (TEAEs)', 'timeFrame': 'From baseline (week 0) to end of study (week 25)', 'description': 'Measured as count of events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n* Japanese male or female.\n* Age 18 years or above at the time of signing the informed consent.\n* Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 90 days prior to day of screening.\n* Glycated haemoglobin (HbA1c) of 7.0-10.5 percent (%) (53-91 millimoles per mole \\[mmol /mol\\]) (both inclusive) at screening.\n* 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.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to study intervention(s) or related products.\n* Previous participation in this study. Participation is defined as signed informed consent.\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.\n* Current participation (i.e., signed informed consent) in any other interventional clinical study.\n* 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.\n* Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.\n* Previous or planned (during the study period) obesity treatment with surgery or a weight loss device.\n* Anticipated initiation or change in concomitant medications for more than 14 consecutive days affecting weight or glucose metabolism.\n* Use of any medication with unknown or unspecified content within 90 days before screening.\n* Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.\n* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.\n* History or presence of pancreatitis (acute or chronic).\n* History of major surgical procedures involving the stomach potentially affecting absorption of study products or current presence of gastrointestinal implant.\n* Myocardial infarction, stroke, transient ischaemic attack or hospitalization for unstable angina pectoris within 60 days before screening.\n* Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.\n* Planned coronary, carotid or peripheral artery revascularisation.\n* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified within 90 days before screening or in the period between screening and randomisation.\n* Impaired liver function, defined as Alanine Aminotransferase (ALT) ≥ 2.5 times or Bilirubin \\>1.5 times upper normal limit at screening.\n* 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.\n* 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.\n* Presence or history of malignant neoplasms or in situ carcinomas within 5 years before screening.\n* Any episodes of diabetic ketoacidosis within 90 days before screening."}, 'identificationModule': {'nctId': 'NCT07271251', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Study Investigating Clinical Comparability of Two Formulations of Oral Semaglutide in Japanese Participants With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NN9924-8485'}, 'secondaryIdInfos': [{'id': 'U1111-1321-8272', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral semaglutide D', 'description': 'Participants will receive oral semaglutide D once daily.', 'interventionNames': ['Drug: Oral semaglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Oral semaglutide', 'description': 'Participants will receive oral semaglutide once daily.', 'interventionNames': ['Drug: Oral semaglutide']}], 'interventions': [{'name': 'Oral semaglutide', 'type': 'DRUG', 'description': 'Semaglutide will be administered orally once daily.', 'armGroupLabels': ['Oral semaglutide', 'Oral semaglutide D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '963-8851', 'city': 'Koriyama-shi', 'state': 'Fukushima, Japan', 'country': 'Japan', 'facility': 'Seino Internal Medicine Clinic_Internal medicine'}, {'zip': '253-0044', 'city': 'Chigasaki-shi', 'state': 'Kanagawa, Japan', 'country': 'Japan', 'facility': 'Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine'}, {'zip': '862-0976', 'city': 'Kumamoto', 'state': 'Kumamoto, Japan', 'country': 'Japan', 'facility': 'Jinnouchi Hospital_Internal Medicine', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '880-0034', 'city': 'Miyazaki', 'state': 'Miyazaki', 'country': 'Japan', 'facility': 'Heiwadai Hospital_Internal Medicine', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'zip': '468-0009', 'city': 'Aichi', 'country': 'Japan', 'facility': 'TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': '261-0004', 'city': 'Chiba', 'country': 'Japan', 'facility': 'Tokuyama clinic_Diabetic internal medicine', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '819-0006', 'city': 'Fukuoka-shi, Fukuoka', 'country': 'Japan', 'facility': 'Futata Tetsuhiro Clinic Meinohama_Internal medicine'}, {'zip': '060-0001', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Oodouri Diabetes, Internal medicine Clinic_Internal Medicine, Diabetes Internal Medicine'}, {'zip': '311-0113', 'city': 'Ibaraki', 'country': 'Japan', 'facility': 'Naka Kinen Clinic_Internal medicine', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'zip': '232-0064', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Yokohama Minoru Clinic_Internal medicine', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '247-0055', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Shonan Takai Clinic_Internal Medicine', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '340-0015', 'city': 'Soka-shi, Saitama', 'country': 'Japan', 'facility': 'Soka Sugiura Internal Medicine Clinic', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '323-0022', 'city': 'Tochigi', 'country': 'Japan', 'facility': 'Oyama East Clinic_Internal Medicine', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}, {'zip': '103-0027', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo-Eki Center-building Clinic_Internal Medicine', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '125-0054', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Kato Clinic of Internal Medicine_Internal Medicine', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'centralContacts': [{'name': 'Novo Nordisk', 'role': 'CONTACT', 'email': 'clinicaltrials@novonordisk.com', 'phone': '(+1) 866-867-7178'}], 'overallOfficials': [{'name': 'Clinical Transparency dept. 2834', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}