Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-29 @ 11:13 PM
Study NCT ID:
NCT04707469
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2021-01-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'phone': '(+1) 866-867-7178', 'title': 'Clinical Reporting Office (2834)', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Week 0 to week 73', 'description': 'Serious adverse events and other AEs were based on the on-treatment observation period, i.e., time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.', 'otherNumAtRisk': 534, 'deathsNumAtRisk': 534, 'otherNumAffected': 277, 'seriousNumAtRisk': 534, 'deathsNumAffected': 2, 'seriousNumAffected': 53}, {'id': 'EG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.', 'otherNumAtRisk': 534, 'deathsNumAtRisk': 534, 'otherNumAffected': 294, 'seriousNumAtRisk': 534, 'deathsNumAffected': 6, 'seriousNumAffected': 57}, {'id': 'EG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.', 'otherNumAtRisk': 534, 'deathsNumAtRisk': 534, 'otherNumAffected': 314, 'seriousNumAtRisk': 534, 'deathsNumAffected': 2, 'seriousNumAffected': 44}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 25, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 34, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 27, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 52, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 55, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 65, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 68, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 68, 'numAffected': 66}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 46, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 41, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 39, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 43, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 42, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 61, 'numAffected': 58}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 44, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 40, 'numAffected': 35}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 84, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 108, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 150, 'numAffected': 76}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 32, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 47, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 50, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 63, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 81, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 81, 'numAffected': 38}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 28, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 27, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 30, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 119, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 222, 'numAffected': 145}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 218, 'numAffected': 146}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 69, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 155, 'numAffected': 91}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 184, 'numAffected': 97}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Abscess intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Abscess oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Bile duct stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Brachial plexus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cataract subcapsular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cellulitis', 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25'}, {'term': 'Vascular graft occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '497', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}, {'value': '492', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '1.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '-0.12', 'pValueComment': 'Unadjusted two-sided p-value for test of no difference.', 'groupDescription': 'Treatment policy estimand', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': "Change from baseline was analyzed using an ANCOVA model with treatment, strata and region as categorical fixed effects and baseline value as covariate for each of the 1000 imputed complete datasets,and pooled by Rubin's rule to draw inference."}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '-0.38', 'pValueComment': 'Unadjusted two-sided p-value for test of no difference.', 'groupDescription': 'Treatment policy estimand', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': "Change from baseline was analyzed using an ANCOVA model with treatment, strata and region as categorical fixed effects and baseline value as covariate for each of the 1000 imputed complete datasets,and pooled by Rubin's rule to draw inference."}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.', 'unitOfMeasure': 'Percentage point of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '495', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.4', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '-8.3', 'spread': '7.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Change from baseline (week 0) in body weight was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'Kilogram (Kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c (Week 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}, {'value': '491', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '1.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Change from baseline (week 0) in HbA1c was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.', 'unitOfMeasure': 'Percentage point of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Week 12 in HbA1c (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '333', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}, {'value': '339', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '1.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12, Week 52', 'description': 'Change in HbA1c was evaluated from week 12 to week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.', 'unitOfMeasure': 'Percentage point of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '460', 'groupId': 'OG001'}, {'value': '482', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '3.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'millimole per litre (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FPG (Week 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}, {'value': '485', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '3.7', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '3.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Change from baseline (week 0) in FPG was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '535', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '50.5', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At week 52', 'description': 'Percentage of participants who achieved HbA1c \\<7.0 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved HbA1c < 7.0 % (Week 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '535', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000'}, {'value': '49.9', 'groupId': 'OG001'}, {'value': '58.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At week 68', 'description': 'Percentage of participants who achieved HbA1c \\<7.0 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 % (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '535', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000'}, {'value': '39.6', 'groupId': 'OG001'}, {'value': '51.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At week 52', 'description': 'Percentage of participants who achieved HbA1c \\<=6.5 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved HbA1c <= 6.5 % (Week 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '535', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000'}, {'value': '35.8', 'groupId': 'OG001'}, {'value': '46.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At week 68', 'description': 'Percentage of participants who achieved HbA1c \\<=6.5 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Time to Event Analyses of Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Due to insufficient number of participants with events to calculate via Kaplan Meir, data was not estimable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to insufficient number of participants with events to calculate via Kaplan Meir, data was not estimable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to insufficient number of participants with events to calculate via Kaplan Meir, data was not estimable.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Time to event analyses of rescue medication was evaluated from baseline (week 0) to week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight (Week 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '495', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.5', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '7.4', 'groupId': 'OG001'}, {'value': '-8.2', 'spread': '8.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Change from baseline (week 0) in body weight was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Body Weight (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '495', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.7', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '6.6', 'groupId': 'OG001'}, {'value': '-8.5', 'spread': '7.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Percentage change from baseline (week 0) in body weight was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'Percentage change in body weight', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Body Weight (Week 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '495', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.7', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '7.1', 'groupId': 'OG001'}, {'value': '-8.4', 'spread': '7.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Percentage change from baseline (week 0) in body weight was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'Percentage change in body weight', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Week 12 in Body Weight (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '5.4', 'groupId': 'OG001'}, {'value': '-5.4', 'spread': '6.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12, Week 52', 'description': 'Percentage change in body weight was evaluated from week 12 to week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'Percentage change in body weight', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Mass Index (BMI) (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '503', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '495', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '-2.9', 'spread': '2.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'kilogram per square metre (kg/m^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BMI (Week 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '495', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '-2.9', 'spread': '2.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Change from baseline (week 0) in BMI was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Waist Circumference (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '494', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4', 'spread': '7', 'groupId': 'OG000'}, {'value': '-5', 'spread': '7', 'groupId': 'OG001'}, {'value': '-6', 'spread': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Change from baseline (week 0) in waist circumference was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'centimetre (cm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Waist Circumference (Week 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '476', 'groupId': 'OG001'}, {'value': '495', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4', 'spread': '6', 'groupId': 'OG000'}, {'value': '-6', 'spread': '7', 'groupId': 'OG001'}, {'value': '-7', 'spread': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Change from baseline (week 0) in waist circumference was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Weight Loss Greater Than or Equal to (>=) 5 % (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '535', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '67.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At week 52', 'description': 'Percentage of participants who achieved weight loss \\>= 5 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Weight Loss >= 5 % (Week 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '535', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000'}, {'value': '58.5', 'groupId': 'OG001'}, {'value': '65.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At week 68', 'description': 'Percentage of participants who achieved weight loss \\>= 5 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '535', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '37.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At week 52', 'description': 'Percentage of participants who achieved weight loss \\>= 10 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '535', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '29.4', 'groupId': 'OG001'}, {'value': '34.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At week 68', 'description': 'Percentage of participants who achieved weight loss \\>= 10 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Cholesterol (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}, {'value': '486', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '0.94', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Change from baseline (week 0) in total cholesterol was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Cholesterol (Week 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '484', 'groupId': 'OG000'}, {'value': '470', 'groupId': 'OG001'}, {'value': '487', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '1.05', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '1.00', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 68', 'description': 'Change from baseline (week 0) in total cholesterol was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Low Density Lipoproteins (LDL) (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}, {'value': '473', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.76', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Change from baseline (week 0) in LDL was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in LDL (Week 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '472', 'groupId': 'OG000'}, {'value': '459', 'groupId': 'OG001'}, {'value': '476', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.79', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 68', 'description': 'Change from baseline (week 0) in LDL was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High Density Lipoproteins (HDL) (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}, {'value': '474', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.18', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Change from baseline (week 0) in HDL was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HDL (Week 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '473', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}, {'value': '476', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '0.20', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 68', 'description': 'Change from baseline (week 0) in HDL was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Triglycerides (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}, {'value': '483', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.46', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '2.08', 'groupId': 'OG001'}, {'value': '-0.71', 'spread': '1.40', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Change from baseline (week 0) in triglycerides was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Triglycerides (Week 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}, {'value': '486', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.51', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '2.06', 'groupId': 'OG001'}, {'value': '-0.70', 'spread': '1.43', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 68', 'description': 'Change from baseline (week 0) in triglycerides was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '534', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '1641', 'groupId': 'OG000'}, {'value': '2055', 'groupId': 'OG001'}, {'value': '2115', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (week 0) up to week 73', 'description': 'An adverse event (AE) defined as any unfavourable and unintended sign, including an abnormal laboratory finding, symptom or disease (new or exacerbated) temporally associated with the use of an investigational medicinal products (IMP). Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAS) which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '534', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'title': 'Level 2', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'Level 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (week 0) up to week 68', 'description': 'Hypoglycaemic episodes were classified according to the American Diabetes Association 2018/ International Hypoglycaemia Study Group 2017, where glycemic criteria for level 2 was \\< 3.0 mmol/L (54 mg/dL) and level 3 had no specific glucose threshold. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.', 'unitOfMeasure': 'Count of episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '434', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4', 'spread': '14', 'groupId': 'OG000'}, {'value': '-6', 'spread': '13', 'groupId': 'OG001'}, {'value': '-6', 'spread': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Change from baseline (week 0) in systolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.', 'unitOfMeasure': 'millimetres of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure (Week 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}, {'value': '429', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4', 'spread': '13', 'groupId': 'OG000'}, {'value': '-6', 'spread': '13', 'groupId': 'OG001'}, {'value': '-5', 'spread': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Change from baseline (week 0) in systolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Diastolic Blood Pressure (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '434', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2', 'spread': '8', 'groupId': 'OG000'}, {'value': '-2', 'spread': '8', 'groupId': 'OG001'}, {'value': '-2', 'spread': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Change from baseline (week 0) in diastolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Diastolic Blood Pressure (Week 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}, {'value': '429', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3', 'spread': '8', 'groupId': 'OG000'}, {'value': '-3', 'spread': '8', 'groupId': 'OG001'}, {'value': '-2', 'spread': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Change from baseline (week 0) in diastolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pulse (Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}, {'value': '434', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '10', 'groupId': 'OG000'}, {'value': '2', 'spread': '10', 'groupId': 'OG001'}, {'value': '3', 'spread': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Change from baseline (week 0) in pulse at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.', 'unitOfMeasure': 'beats per minute (beats/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pulse (Week 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '429', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '10', 'groupId': 'OG000'}, {'value': '2', 'spread': '10', 'groupId': 'OG001'}, {'value': '2', 'spread': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Change from baseline (week 0) in pulse at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS which comprised all participants who received at least 1 dose of trial treatment. Overall number of participants analyzed = participants with available data for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'FG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'FG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '536'}, {'groupId': 'FG001', 'numSubjects': '535'}, {'groupId': 'FG002', 'numSubjects': '535'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '534'}, {'groupId': 'FG001', 'numSubjects': '534'}, {'groupId': 'FG002', 'numSubjects': '534'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '536'}, {'groupId': 'FG001', 'numSubjects': '535'}, {'groupId': 'FG002', 'numSubjects': '535'}]}, {'type': 'Safety Analysis Set (SAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '534'}, {'groupId': 'FG001', 'numSubjects': '534'}, {'groupId': 'FG002', 'numSubjects': '534'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '507'}, {'groupId': 'FG001', 'numSubjects': '490'}, {'groupId': 'FG002', 'numSubjects': '505'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Site closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'The trial was conducted in 14 countries (184 sites screened/177 randomised participants) as follows: Australia: 7/6; Bulgaria: 15/15; Canada: 13/13; Croatia: 5/5; Czech Republic: 5/5; Estonia: 6/5; Germany: 8/8; Hungary: 9/9; India: 20/20; Poland: 18/18; Slovakia: 9/9; Slovenia: 5/5; Taiwan: 2/2; United States: 62/57. In addition, Bulgaria (1 site), Canada (1 site), Croatia (1 site) and Poland (1 site) were approved by the institutional review board, but did not randomise any participant.', 'preAssignmentDetails': 'Participants were randomized in 1:1:1 ratio to receive either 14 milligram (mg), 25 mg or 50 mg oral semaglutide once daily. The trial had a 68-week treatment period (8-16 weeks of dose escalation period and 52-60 weeks of maintenance period), followed by a 5-week follow-up period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '536', 'groupId': 'BG000'}, {'value': '535', 'groupId': 'BG001'}, {'value': '535', 'groupId': 'BG002'}, {'value': '1606', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 68.'}, {'id': 'BG001', 'title': 'Oral Semaglutide 25 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12 and 25 mg from week 12 to week 68.'}, {'id': 'BG002', 'title': 'Oral Semaglutide 50 mg', 'description': 'Participants were to take oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 68: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8, 14 mg from week 8 to 12, 25 mg from week 12 to week 16 and 50 mg from week 16 to week 68.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.4', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '58.8', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '57.6', 'spread': '11.2', 'groupId': 'BG002'}, {'value': '58.2', 'spread': '10.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}, {'value': '670', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '325', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}, {'value': '936', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '498', 'groupId': 'BG000'}, {'value': '498', 'groupId': 'BG001'}, {'value': '499', 'groupId': 'BG002'}, {'value': '1495', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '269', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '424', 'groupId': 'BG000'}, {'value': '432', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}, {'value': '1254', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all randomised participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-16', 'size': 963998, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-05T08:13', 'hasProtocol': True}, {'date': '2022-12-23', 'size': 1661933, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-05T08:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sponsor staff involved in the clinical trial is masked according to company standard procedures.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1606}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2021-01-12', 'resultsFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2021-01-12', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-03-05', 'studyFirstPostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Glycated Haemoglobin (HbA1c) (Week 52)', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Body Weight (Week 52)', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Change from baseline (week 0) in body weight was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Change From Baseline in HbA1c (Week 68)', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Change from baseline (week 0) in HbA1c was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.'}, {'measure': 'Change From Week 12 in HbA1c (Week 52)', 'timeFrame': 'Week 12, Week 52', 'description': 'Change in HbA1c was evaluated from week 12 to week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment. Percentage point refers to arithmetic difference between two percentages.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) (Week 52)', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Change From Baseline in FPG (Week 68)', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Change from baseline (week 0) in FPG was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Percentage of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Week 52)', 'timeFrame': 'At week 52', 'description': 'Percentage of participants who achieved HbA1c \\<7.0 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Percentage of Participants Who Achieved HbA1c < 7.0 % (Week 68)', 'timeFrame': 'At week 68', 'description': 'Percentage of participants who achieved HbA1c \\<7.0 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Percentage of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 % (Week 52)', 'timeFrame': 'At week 52', 'description': 'Percentage of participants who achieved HbA1c \\<=6.5 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Percentage of Participants Who Achieved HbA1c <= 6.5 % (Week 68)', 'timeFrame': 'At week 68', 'description': 'Percentage of participants who achieved HbA1c \\<=6.5 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Time to Event Analyses of Rescue Medication', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Time to event analyses of rescue medication was evaluated from baseline (week 0) to week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Change From Baseline in Body Weight (Week 68)', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Change from baseline (week 0) in body weight was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Percentage Change From Baseline in Body Weight (Week 52)', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Percentage change from baseline (week 0) in body weight was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Percentage Change From Baseline in Body Weight (Week 68)', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Percentage change from baseline (week 0) in body weight was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Percentage Change From Week 12 in Body Weight (Week 52)', 'timeFrame': 'Week 12, Week 52', 'description': 'Percentage change in body weight was evaluated from week 12 to week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Change From Baseline in Body Mass Index (BMI) (Week 52)', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Change From Baseline in BMI (Week 68)', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Change from baseline (week 0) in BMI was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Change From Baseline in Waist Circumference (Week 52)', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Change from baseline (week 0) in waist circumference was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Change From Baseline in Waist Circumference (Week 68)', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Change from baseline (week 0) in waist circumference was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Percentage of Participants Who Achieved Weight Loss Greater Than or Equal to (>=) 5 % (Week 52)', 'timeFrame': 'At week 52', 'description': 'Percentage of participants who achieved weight loss \\>= 5 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Percentage of Participants Who Achieved Weight Loss >= 5 % (Week 68)', 'timeFrame': 'At week 68', 'description': 'Percentage of participants who achieved weight loss \\>= 5 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 52)', 'timeFrame': 'At week 52', 'description': 'Percentage of participants who achieved weight loss \\>= 10 % at week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Percentage of Participants Who Achieved Weight Loss >= 10 % (Week 68)', 'timeFrame': 'At week 68', 'description': 'Percentage of participants who achieved weight loss \\>= 10 % at week 68 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Change From Baseline in Total Cholesterol (Week 52)', 'timeFrame': 'Baseline, Week 52', 'description': 'Change from baseline (week 0) in total cholesterol was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Change From Baseline in Total Cholesterol (Week 68)', 'timeFrame': 'Baseline, Week 68', 'description': 'Change from baseline (week 0) in total cholesterol was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Change From Baseline in Low Density Lipoproteins (LDL) (Week 52)', 'timeFrame': 'Baseline, Week 52', 'description': 'Change from baseline (week 0) in LDL was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Change From Baseline in LDL (Week 68)', 'timeFrame': 'Baseline, Week 68', 'description': 'Change from baseline (week 0) in LDL was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Change From Baseline in High Density Lipoproteins (HDL) (Week 52)', 'timeFrame': 'Baseline, Week 52', 'description': 'Change from baseline (week 0) in HDL was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Change From Baseline in HDL (Week 68)', 'timeFrame': 'Baseline, Week 68', 'description': 'Change from baseline (week 0) in HDL was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Change From Baseline in Triglycerides (Week 52)', 'timeFrame': 'Baseline, Week 52', 'description': 'Change from baseline (week 0) in triglycerides was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Change From Baseline in Triglycerides (Week 68)', 'timeFrame': 'Baseline, Week 68', 'description': 'Change from baseline (week 0) in triglycerides was evaluated at week 68. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of additional anti-diabetic medication or discontinuation of trial treatment.'}, {'measure': 'Number of Adverse Events', 'timeFrame': 'From baseline (week 0) up to week 73', 'description': 'An adverse event (AE) defined as any unfavourable and unintended sign, including an abnormal laboratory finding, symptom or disease (new or exacerbated) temporally associated with the use of an investigational medicinal products (IMP). Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.'}, {'measure': 'Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) or Severe Hypoglycaemic Episodes (Level 3)', 'timeFrame': 'From baseline (week 0) up to week 68', 'description': 'Hypoglycaemic episodes were classified according to the American Diabetes Association 2018/ International Hypoglycaemia Study Group 2017, where glycemic criteria for level 2 was \\< 3.0 mmol/L (54 mg/dL) and level 3 had no specific glucose threshold. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.'}, {'measure': 'Change From Baseline in Systolic Blood Pressure (Week 52)', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Change from baseline (week 0) in systolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.'}, {'measure': 'Change From Baseline in Systolic Blood Pressure (Week 68)', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Change from baseline (week 0) in systolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.'}, {'measure': 'Change From Baseline in Diastolic Blood Pressure (Week 52)', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Change from baseline (week 0) in diastolic blood pressure at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.'}, {'measure': 'Change From Baseline in Diastolic Blood Pressure (Week 68)', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Change from baseline (week 0) in diastolic blood pressure at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.'}, {'measure': 'Change From Baseline in Pulse (Week 52)', 'timeFrame': 'Baseline (week 0), week 52', 'description': 'Change from baseline (week 0) in pulse at week 52 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.'}, {'measure': 'Change From Baseline in Pulse (Week 68)', 'timeFrame': 'Baseline (week 0), week 68', 'description': 'Change from baseline (week 0) in pulse at week 68 are presented. Results are based on the data from the on-treatment observation period, which was the time period when a participant was on trial treatment, including any period after initiation of rescue medication.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '37385279', 'type': 'RESULT', 'citation': 'Aroda VR, Aberle J, Bardtrum L, Christiansen E, Knop FK, Gabery S, Pedersen SD, Buse JB. Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial. Lancet. 2023 Aug 26;402(10403):693-704. doi: 10.1016/S0140-6736(23)01127-3. Epub 2023 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'This study compares three doses of once daily semaglutide tablets in people with type 2 diabetes who were previously treated with other oral anti-diabetic medicines. Participants will be initiated on the lowest starting dose of 3 mg and gradually increased until they reach the final trial dose of 14 mg, 25 mg or 50 mg once daily semaglutide tablets. The final three doses will be randomized (i.e., decided by chance). Participants will be administered one tablet per day for 68 weeks. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period. Women who can get pregnant will be checked for pregnancy via urine tests. Once daily semaglutide tablets (3 mg, 7 mg and 14 mg) are approved for the treatment of type 2 diabetes in the US, in the EU and in some other countries, under the brand name Rybelsus®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age above or equal to 18 years at the time of signing informed consent.\n* Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.\n* HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive).\n* BMI equal to or above 25 kg/m\\^2\n* Stable daily dose(s) for 90 days prior to the day of screening of any of the following treatment regimens:\n* No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a \\*:\n\n * Metformin (equal to or above1500 mg or maximum tolerated or effective dose).\n * Sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose).\n * Sodium/glucose cotransporter 2 (SGLT2) inhibitors (maximum tolerated dose).\n* Dipeptidyl peptidase-4 (DPP-4) inhibitors (maximally indicated dose as per local label).\n* Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be willing to discontinue DPP-4 inhibitor treatment at randomisation (with no wash-out).\n\nExclusion Criteria:\n\n* Treatment with any medication indicated for the treatment of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed.\n* Renal impairment measured as estimated glomerular filtration rate (eGFR) value of below 30 mL/min/1.73 m\\^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by kidney disease improving global outcomes (KDIGO 2012) classification.\n* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.'}, 'identificationModule': {'nctId': 'NCT04707469', 'acronym': 'PIONEER PLUS', 'briefTitle': 'Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Efficacy and Safety of Once-daily Oral Semaglutide 25 mg and 50 mg Compared With 14 mg in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NN9924-4635'}, 'secondaryIdInfos': [{'id': 'U1111-1247-0210', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': '2020-000299-39', 'type': 'REGISTRY', 'domain': 'European Medicines Agency (EudraCT)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral semaglutide 50 mg', 'description': 'Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12), 25 mg (week 13-16) and 50 mg (week 17-68).', 'interventionNames': ['Drug: Oral semaglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Oral semaglutide 25 mg', 'description': 'Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12) and 25 mg (week 13-68).', 'interventionNames': ['Drug: Oral semaglutide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral semaglutide 14 mg', 'description': 'Participants will receive once daily semaglutide tablets in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8) and 14 mg (week 9-68).', 'interventionNames': ['Drug: Oral semaglutide']}], 'interventions': [{'name': 'Oral semaglutide', 'type': 'DRUG', 'description': 'Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 68 weeks.', 'armGroupLabels': ['Oral semaglutide 14 mg', 'Oral semaglutide 25 mg', 'Oral semaglutide 50 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90620', 'city': 'Buena Park', 'state': 'California', 'country': 'United States', 'facility': 'American Clinical Trials', 'geoPoint': {'lat': 33.86751, 'lon': -117.99812}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Valley Research', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Velocity Clin Res San Diego', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'First Valley Medical Group', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Clinical Studies', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, 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