Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-01 @ 1:52 PM
Study NCT ID:
NCT04017832
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2019-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin 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'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'phone': '(+1) 866-867-7178', 'title': 'Clinical Reporting Anchor and Disclosure (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': 'From baseline to week 31', 'description': 'AEs with onset during the on-treatment period correspond to TEAEs. On-treatment observation period represented the time period where participants were considered treated with the trial product following randomization. Results are based on the SAS which included all participants exposed to at least one dose of trial product.', 'eventGroups': [{'id': 'EG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.', 'otherNumAtRisk': 361, 'deathsNumAtRisk': 361, 'otherNumAffected': 109, 'seriousNumAtRisk': 361, 'deathsNumAffected': 2, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.', 'otherNumAtRisk': 358, 'deathsNumAtRisk': 358, 'otherNumAffected': 117, 'seriousNumAtRisk': 358, 'deathsNumAffected': 2, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.', 'otherNumAtRisk': 361, 'deathsNumAtRisk': 361, 'otherNumAffected': 144, 'seriousNumAtRisk': 361, 'deathsNumAffected': 1, 'seriousNumAffected': 11}, {'id': 'EG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.', 'otherNumAtRisk': 358, 'deathsNumAtRisk': 358, 'otherNumAffected': 65, 'seriousNumAtRisk': 358, 'deathsNumAffected': 0, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 39, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 31, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 40, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 57, 'numAffected': 48}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 38, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 42, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 50, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 29, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 35, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 35, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 30, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 38, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Cerebrovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Dacryocystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Dacryostenosis acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Fracture treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Infected skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Keratitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Lacrimal gland abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Macular fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Stab wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 358, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}, {'value': '350', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'title': 'On-treatment observation period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}, {'value': '334', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '1.0', 'groupId': 'OG003'}]}]}, {'title': 'In-trial observation period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}, {'value': '350', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '1.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0078', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '-0.1', 'pValueComment': 'Unadjusted two-sided p-value', 'statisticalMethod': 'Mixed model for repeated measurements', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '-0.6', 'pValueComment': 'Unadjusted two-sided p-value', 'statisticalMethod': 'Mixed model for repeated measurements', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.8', 'pValueComment': 'Unadjusted two-sided p-value', 'statisticalMethod': 'Mixed model for repeated measurements', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change in HbA1c from baseline to week 26 in percentage (%) point of HbA1c is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period and in-trial observation period. On-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. In-trial observation period: the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication.', 'unitOfMeasure': 'Percentage point of HbA1C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure and Number Analyzed: number of participants with available data for each specified category.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}, {'value': '294', 'groupId': 'OG002'}, {'value': '329', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.03', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '-1.79', 'spread': '2.20', 'groupId': 'OG001'}, {'value': '-2.00', 'spread': '2.42', 'groupId': 'OG002'}, {'value': '-0.52', 'spread': '2.36', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change in fasting plasma glucose (FPG) from baseline to week 26 in millimole per liter (mmol/l) is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '317', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '-1.2', 'spread': '2.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in mean 7-point SMPG profile at week 26 is presented. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '317', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '2.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in 7-point SMPG: Mean postprandial increment (over all meals) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}, {'value': '334', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '182', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '212', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 26', 'description': 'Number of participants who achieved HbA1c \\<7.0% (53 mmol/mol) (ADA target) is presented in category "Yes" and participants who could not achieve HbA1C \\<7.0 (53 mmol/mol) (ADA target) is presented in category "No". The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomised participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}, {'value': '334', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '240', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '280', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 26', 'description': 'Number of participants who achieved HbA1c equal to or below 6.5 percent (48 mmol/mol) (AACE target) (yes/no) is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}, {'value': '334', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '180', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '205', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 26', 'description': 'Number of participants who achieved HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) (yes/no) is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '359', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to week 31', 'description': "Time to rescue medication is presented as the number of participants who had taken rescue medication anytime from baseline to week 31. 'Rescue medication': use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Body Weight (Kilogram [kg])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '300', 'groupId': 'OG002'}, {'value': '335', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '3.7', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '2.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change in body weight from baseline to week 26 in kg is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.', 'unitOfMeasure': 'Kilogram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline to Week 26 in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '300', 'groupId': 'OG002'}, {'value': '335', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2', 'spread': '4', 'groupId': 'OG000'}, {'value': '-4', 'spread': '4', 'groupId': 'OG001'}, {'value': '-5', 'spread': '5', 'groupId': 'OG002'}, {'value': '-1', 'spread': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Percentage change from baseline to week 26 in body weight is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '300', 'groupId': 'OG002'}, {'value': '335', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in BMI is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.', 'unitOfMeasure': 'Kilogram per square meter (kg/m^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}, {'value': '300', 'groupId': 'OG002'}, {'value': '335', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '-3.7', 'spread': '4.1', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '3.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in waist circumference is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.', 'unitOfMeasure': 'Centimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}, {'value': '330', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'spread': '15.78', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '17.34', 'groupId': 'OG001'}, {'value': '0.96', 'spread': '17.86', 'groupId': 'OG002'}, {'value': '0.99', 'spread': '19.69', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in total cholesterol (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.', 'unitOfMeasure': 'Ratio of total cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}, {'value': '327', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'spread': '25.63', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '28.70', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '28.95', 'groupId': 'OG002'}, {'value': '1.01', 'spread': '30.12', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in LDL cholesterol (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.', 'unitOfMeasure': 'Ratio of LDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Fasting Lipid Profile: Very-low-density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}, {'value': '327', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.05', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '0.94', 'spread': '0.41', 'groupId': 'OG002'}, {'value': '0.98', 'spread': '0.43', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in VLDL cholesterol (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.', 'unitOfMeasure': 'Ratio of VLDL cholesterol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}, {'value': '293', 'groupId': 'OG002'}, {'value': '323', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'spread': '13.25', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '14.42', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '14.82', 'groupId': 'OG002'}, {'value': '1.00', 'spread': '16.03', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in HDL Cholesterol (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.', 'unitOfMeasure': 'Ratio of HDL cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Fasting Lipid Profile: Triglycerides (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}, {'value': '327', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'spread': '43.41', 'groupId': 'OG000'}, {'value': '0.86', 'spread': '46.28', 'groupId': 'OG001'}, {'value': '0.86', 'spread': '46.40', 'groupId': 'OG002'}, {'value': '0.91', 'spread': '44.29', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in triglycerides (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.', 'unitOfMeasure': 'Ratio of triglycerides', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Fasting Lipid Profile: Free Fatty Acids (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '318', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.95', 'spread': '56.36', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '56.46', 'groupId': 'OG001'}, {'value': '0.87', 'spread': '66.18', 'groupId': 'OG002'}, {'value': '0.96', 'spread': '62.50', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in free fatty acids (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.', 'unitOfMeasure': 'Ratio of free fatty acids', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '334', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'title': 'Physical Function', 'categories': [{'measurements': [{'value': '0.20', 'spread': '5.63', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '3.95', 'groupId': 'OG001'}, {'value': '0.93', 'spread': '4.51', 'groupId': 'OG002'}, {'value': '0.31', 'spread': '5.25', 'groupId': 'OG003'}]}]}, {'title': 'Role Physical', 'categories': [{'measurements': [{'value': '-0.47', 'spread': '6.72', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '6.82', 'groupId': 'OG001'}, {'value': '0.28', 'spread': '6.11', 'groupId': 'OG002'}, {'value': '0.24', 'spread': '7.27', 'groupId': 'OG003'}]}]}, {'title': 'Bodily Pain', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '8.44', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '8.08', 'groupId': 'OG001'}, {'value': '0.51', 'spread': '8.03', 'groupId': 'OG002'}, {'value': '0.22', 'spread': '8.44', 'groupId': 'OG003'}]}]}, {'title': 'General Health', 'categories': [{'measurements': [{'value': '1.47', 'spread': '7.54', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '7.09', 'groupId': 'OG001'}, {'value': '1.95', 'spread': '7.44', 'groupId': 'OG002'}, {'value': '0.95', 'spread': '7.19', 'groupId': 'OG003'}]}]}, {'title': 'Vitality', 'categories': [{'measurements': [{'value': '0.44', 'spread': '6.68', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '6.64', 'groupId': 'OG001'}, {'value': '1.21', 'spread': '7.66', 'groupId': 'OG002'}, {'value': '0.33', 'spread': '7.28', 'groupId': 'OG003'}]}]}, {'title': 'Social Function', 'categories': [{'measurements': [{'value': '0.49', 'spread': '6.14', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '6.45', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '5.92', 'groupId': 'OG002'}, {'value': '0.10', 'spread': '6.36', 'groupId': 'OG003'}]}]}, {'title': 'Role Emotional', 'categories': [{'measurements': [{'value': '0.06', 'spread': '8.80', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '8.37', 'groupId': 'OG001'}, {'value': '0.23', 'spread': '8.26', 'groupId': 'OG002'}, {'value': '0.03', 'spread': '8.40', 'groupId': 'OG003'}]}]}, {'title': 'Mental Health', 'categories': [{'measurements': [{'value': '0.51', 'spread': '7.01', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '6.71', 'groupId': 'OG001'}, {'value': '0.70', 'spread': '7.34', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '7.13', 'groupId': 'OG003'}]}]}, {'title': 'Physical Component', 'categories': [{'measurements': [{'value': '0.15', 'spread': '5.32', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '4.74', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '5.00', 'groupId': 'OG002'}, {'value': '0.69', 'spread': '5.62', 'groupId': 'OG003'}]}]}, {'title': 'Mental Component', 'categories': [{'measurements': [{'value': '0.50', 'spread': '6.71', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '6.50', 'groupId': 'OG001'}, {'value': '0.44', 'spread': '6.75', 'groupId': 'OG002'}, {'value': '-0.39', 'spread': '6.64', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 26', 'description': "SF-36 v2.0 is a 36-item, patient-reported survey of patient health. SF-36 measures the participant's overall Health Related Quality of Life on 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) and two component summary scores (physical component summary and mental component summary). Range of score for domains and component summary scores : 1-100 (Higher scores indicated a better health state). A positive change score indicates an improvement since baseline. Outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to end date which was first date of any of following: the last dose of trial product plus 3 days or initiation of rescue medication.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure and Number Analyzed: number of participants with available data for each specified category.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}, {'value': '350', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '234', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '282', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 26', 'description': 'Number of participants who achieved body weight loss equal to or above 3 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}, {'value': '333', 'groupId': 'OG002'}, {'value': '351', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '288', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}, {'value': '323', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 26', 'description': 'Number of participants who achieved body weight loss equal to or above 5 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}, {'value': '333', 'groupId': 'OG002'}, {'value': '351', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '338', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}, {'value': '291', 'groupId': 'OG002'}, {'value': '349', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 26', 'description': 'Number of participants who achieved body weight loss equal to or above 10 percent (yes/no). The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved HbA1c Below 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}, {'value': '350', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '230', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '271', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 26', 'description': 'Number of participants who achieved HbA1c \\< 7.0 percent (53 mmol/mol) without hypoglycaemia (treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and no body weight gain (yes/no) at week 26 is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) and Body Weight Loss Equal to or Above 3 Percent (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}, {'value': '350', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '280', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}, {'value': '317', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At week 26', 'description': 'Number of participants who achieved HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) and body weight loss equal to or above 3 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Adverse Events During Exposure to Trial Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '635', 'groupId': 'OG000'}, {'value': '741', 'groupId': 'OG001'}, {'value': '793', 'groupId': 'OG002'}, {'value': '643', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to week 31', 'description': 'An adverse event (AE) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. AEs with onset during the on-treatment period correspond to treatment-emergent AEs (TEAEs). The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAS) included all participants exposed to at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to week 31', 'description': "Number of treatment-emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes during exposure to trial product is presented. Severe: requiring assistance from another person for recovery. 'BG-confirmed': hypoglycaemic episode with a plasma glucose value \\< 3.1 mmol/L (56 mg/dL); The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.", 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all all participants exposed to at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '320', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'title': 'Basophils', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.04', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.05', 'groupId': 'OG003'}]}]}, {'title': 'Eosinophils', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.25', 'groupId': 'OG002'}, {'value': '-0.00', 'spread': '0.11', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.40', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.52', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.39', 'groupId': 'OG003'}]}]}, {'title': 'Monocytes', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.14', 'groupId': 'OG002'}, {'value': '0.02', 'spread': '0.12', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils', 'categories': [{'measurements': [{'value': '0.03', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '0.10', 'spread': '1.22', 'groupId': 'OG002'}, {'value': '0.31', 'spread': '1.17', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in hematology parameters such as basophils, eosinophils, lymphocytes, monocytes, and neutrophils were reported. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': '10^9 cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Haematology Parameter: Haematocrit (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '320', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'spread': '6.76', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '6.64', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '6.21', 'groupId': 'OG002'}, {'value': '1.00', 'spread': '6.35', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in Haematocrit at week 26 is reported as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': 'Ratio of haematocrit', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Haematology Parameter: Haemoglobin (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '320', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'spread': '5.71', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '6.04', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '5.47', 'groupId': 'OG002'}, {'value': '1.00', 'spread': '6.11', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in Haemoglobin at week 26 is reported as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': 'Ratio of haemoglobin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Haematology Parameter: Leucocytes (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '320', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'spread': '19.28', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '19.54', 'groupId': 'OG001'}, {'value': '1.01', 'spread': '21.24', 'groupId': 'OG002'}, {'value': '1.04', 'spread': '17.87', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in Leucocytes at week 26 is reported as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': 'Ratio of leucocytes', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Haematology Parameter: Thrombocytes (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}, {'value': '316', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'spread': '14.53', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '16.65', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '16.65', 'groupId': 'OG002'}, {'value': '0.97', 'spread': '15.65', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in thrombocytes at week 26 is reported as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': 'Ratio of thrombocytes', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Biochemistry Parameter: Calcium (Total) (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '336', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.98', 'spread': '4.40', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '4.74', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '4.80', 'groupId': 'OG002'}, {'value': '0.98', 'spread': '4.40', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in calcium (total) (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': 'Ratio of calcium', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Biochemistry Parameter: Potassium (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '335', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'spread': '8.51', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '8.34', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '8.96', 'groupId': 'OG002'}, {'value': '1.01', 'spread': '9.28', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in potassium (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': 'Ratio of potassium', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Biochemistry Parameter: Sodium (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '335', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '1.49', 'groupId': 'OG002'}, {'value': '1.00', 'spread': '1.59', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in sodium (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': 'Ratio of sodium', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Biochemistry Parameter: Urea (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '336', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'spread': '26.29', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '25.61', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '23.78', 'groupId': 'OG002'}, {'value': '1.03', 'spread': '22.67', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in urea (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': 'Ratio of urea', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Biochemistry Parameter: Albumin (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}, {'value': '303', 'groupId': 'OG002'}, {'value': '337', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'spread': '4.40', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '4.57', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '5.22', 'groupId': 'OG002'}, {'value': '0.99', 'spread': '5.05', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in Albumin (measured in grams per deciliter \\[g/dL\\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': 'Ratio of albumin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Calcitonin (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '335', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'spread': '38.33', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '35.56', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '36.49', 'groupId': 'OG002'}, {'value': '1.01', 'spread': '31.96', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in calcitonin (measured in picograms per milliliter \\[pg/ml\\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': 'Ratio of calcitonin', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed: participants with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Vital Signs: Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'spread': '10', 'groupId': 'OG000'}, {'value': '78', 'spread': '11', 'groupId': 'OG001'}, {'value': '78', 'spread': '10', 'groupId': 'OG002'}, {'value': '78', 'spread': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in pulse rate is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': 'Beats per minute (beats/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Vital Signs: Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '131', 'spread': '16', 'groupId': 'OG000'}, {'value': '132', 'spread': '15', 'groupId': 'OG001'}, {'value': '130', 'spread': '14', 'groupId': 'OG002'}, {'value': '130', 'spread': '14', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in systolic blood pressure is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': 'Millimeter of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Vital Signs: Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'spread': '10', 'groupId': 'OG000'}, {'value': '84', 'spread': '9', 'groupId': 'OG001'}, {'value': '83', 'spread': '10', 'groupId': 'OG002'}, {'value': '83', 'spread': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in diastolic blood pressure is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': 'Millimeter of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Electrocardiogram (ECG) Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}, {'value': '303', 'groupId': 'OG002'}, {'value': '344', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'title': 'Normal (Baseline) to normal (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}, {'value': '197', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '174', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}, {'value': '175', 'groupId': 'OG003'}]}]}, {'title': 'Normal (Baseline) to abnormal NCS (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}, {'value': '197', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Normal (Baseline) to abnormal CS (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}, {'value': '197', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal NCS (Baseline) to normal (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal NCS (Baseline) to abnormal NCS (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal NCS (Baseline) to abnormal CS (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal CS (Baseline) to normal (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal CS (Baseline) to abnormal NCS (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal CS (Baseline) to abnormal CS (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in ECG category at week 26 is presented. Change from baseline results are presented as shift in findings categorized as: normal, abnormal and not clinically significant (NCS), and abnormal and clinically significant (CS). The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed: participants with available data for this outcome measure and Number Analyzed: number of participants with available data for each specified category.'}, {'type': 'SECONDARY', 'title': 'Physical Examination Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'title': 'Cardiovascular system - Normal (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '354', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}, {'value': '356', 'groupId': 'OG003'}]}]}, {'title': 'Cardiovascular system - abnormal NCS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Cardiovascular system - Abnormal CS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Cardiovascular system -Normal (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '339', 'groupId': 'OG003'}]}]}, {'title': 'Cardiovascular system - Abnormal NCS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Cardiovascular system - Abnormal CS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Central and Peripheral Nervous System - Normal (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '355', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}, {'value': '357', 'groupId': 'OG003'}]}]}, {'title': 'Central and Peripheral Nervous System - Abnormal NCS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Central and Peripheral Nervous System - Abnormal CS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Central and Peripheral Nervous System - Normal (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '322', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}, {'value': '339', 'groupId': 'OG003'}]}]}, {'title': 'Central and Peripheral Nervous System - Abnormal NCS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Central and Peripheral Nervous System - Abnormal CS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Gastrointestinal System incl. Mouth - Normal (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '350', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '353', 'groupId': 'OG002'}, {'value': '346', 'groupId': 'OG003'}]}]}, {'title': 'Gastrointestinal System incl. Mouth - Abnormal NCS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Gastrointestinal System incl. Mouth - Abnormal CS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Gastrointestinal System incl. Mouth - Normal (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '314', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '300', 'groupId': 'OG002'}, {'value': '329', 'groupId': 'OG003'}]}]}, {'title': 'Gastrointestinal System incl. Mouth - Abnormal NCS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Gastrointestinal System incl. Mouth - Abnormal CS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'General Appearance - Normal (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '329', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}, {'value': '328', 'groupId': 'OG002'}, {'value': '328', 'groupId': 'OG003'}]}]}, {'title': 'General Appearance - Abnormal NCS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}, {'title': 'General Appearance - Abnormal CS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'General Appearance - Normal (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '300', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}, {'value': '313', 'groupId': 'OG003'}]}]}, {'title': 'General Appearance - Abnormal NCS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}]}, {'title': 'General Appearance - Abnormal CS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Head, Ears, Eyes, Nose, Throat, Neck - Normal (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '360', 'groupId': 'OG002'}, {'value': '355', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '348', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}, {'value': '344', 'groupId': 'OG003'}]}]}, {'title': 'Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '360', 'groupId': 'OG002'}, {'value': '355', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '360', 'groupId': 'OG002'}, {'value': '355', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Head, Ears, Eyes, Nose, Throat, Neck - Normal (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}, {'value': '303', 'groupId': 'OG002'}, {'value': '339', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '322', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}, {'value': '330', 'groupId': 'OG003'}]}]}, {'title': 'Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}, {'value': '303', 'groupId': 'OG002'}, {'value': '339', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}, {'value': '303', 'groupId': 'OG002'}, {'value': '339', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Lymph Node Palpation - Normal (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '361', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}, {'value': '357', 'groupId': 'OG002'}, {'value': '357', 'groupId': 'OG003'}]}]}, {'title': 'Lymph Node Palpation - Abnormal NCS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Lymph Node Palpation - Abnormal CS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lymph Node Palpation - Normal (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '325', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}, {'value': '304', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}]}, {'title': 'Lymph Node Palpation - Abnormal NCS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lymph Node Palpation - Abnormal CS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Musculoskeletal System - Normal (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '344', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}, {'value': '351', 'groupId': 'OG002'}, {'value': '352', 'groupId': 'OG003'}]}]}, {'title': 'Musculoskeletal System - Abnormal NCS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Musculoskeletal System - Abnormal CS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Musculoskeletal System - Normal (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '314', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '335', 'groupId': 'OG003'}]}]}, {'title': 'Musculoskeletal System - Abnormal NCS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Musculoskeletal System - Abnormal CS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Respiratory System - Normal (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '355', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}, {'value': '359', 'groupId': 'OG002'}, {'value': '357', 'groupId': 'OG003'}]}]}, {'title': 'Respiratory System -Abnormal NCS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Respiratory System - Abnormal CS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Respiratory System - Normal (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '324', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}]}, {'title': 'Respiratory System - Abnormal NCS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Respiratory System - Abnormal CS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Skin - Normal (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '282', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '296', 'groupId': 'OG002'}, {'value': '277', 'groupId': 'OG003'}]}]}, {'title': 'Skin - Abnormal NCS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}]}, {'title': 'Skin - Abnormal CS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Skin - Normal (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '260', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}, {'value': '267', 'groupId': 'OG003'}]}]}, {'title': 'Skin - Abnormal NCS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}]}, {'title': 'Skin - Abnormal CS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Thyroid Gland - Normal (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '356', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}, {'value': '350', 'groupId': 'OG003'}]}]}, {'title': 'Thyroid Gland - Abnormal NCS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Thyroid Gland - Abnormal CS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Thyroid Gland - Normal (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '322', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}, {'value': '304', 'groupId': 'OG002'}, {'value': '337', 'groupId': 'OG003'}]}]}, {'title': 'Thyroid Gland - Abnormal NCS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Thyroid Gland - Abnormal CS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '305', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and week 26', 'description': 'The physical examination values for different body systems at baseline and week 26 are presented. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. The physical examination are presented for the following body systems: cardiovascular system; central and peripheral nervous system; gastrointestinal system, including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin; and thyroid gland. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product. Number Analyzed: number of participants with available data for each specified category.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 26 in Eye Examination Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'title': 'Left Eye Ophthalmoscopy - Normal (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '254', 'groupId': 'OG002'}, {'value': '248', 'groupId': 'OG003'}]}]}, {'title': 'Left Eye Ophthalmoscopy - Abnormal NCS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}]}, {'title': 'Left Eye Ophthalmoscopy - Abnormal CS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}]}, {'title': 'Left Eye Ophthalmoscopy - Normal (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '335', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}, {'value': '240', 'groupId': 'OG003'}]}]}, {'title': 'Left Eye Ophthalmoscopy -Abnormal NCS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '335', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}]}, {'title': 'Left Eye Ophthalmoscopy - Abnormal CS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '335', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}]}, {'title': 'Right Eye Ophthalmoscopy - Normal (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '240', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}, {'value': '240', 'groupId': 'OG003'}]}]}, {'title': 'Right Eye Ophthalmoscopy - Abnormal NCS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}]}, {'title': 'Right Eye Ophthalmoscopy - Abnormal CS (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}]}, {'title': 'Right Eye Ophthalmoscopy - Normal (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '335', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '220', 'groupId': 'OG002'}, {'value': '233', 'groupId': 'OG003'}]}]}, {'title': 'Right Eye Ophthalmoscopy - Abnormal NCS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '335', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}]}, {'title': 'Right Eye Ophthalmoscopy - Abnormal CS (Week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '301', 'groupId': 'OG002'}, {'value': '335', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to week 26', 'description': 'The eye examination category at baseline and week 26 are presented. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product. Number Analyzed: number of participants with available data for each specified category.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '358', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'OG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to week 31', 'description': "Number of participants with treatment-emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes during exposure to trial product is presented. Severe: requiring assistance from another person for recovery. 'BG-confirmed': hypoglycaemic episode with a plasma glucose value \\< 3.1 mmol/L (56 mg/dL); The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS included all participants exposed to at least one dose of trial product.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'FG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'FG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'FG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '361'}, {'groupId': 'FG001', 'numSubjects': '360'}, {'groupId': 'FG002', 'numSubjects': '361'}, {'groupId': 'FG003', 'numSubjects': '359'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '361'}, {'groupId': 'FG001', 'numSubjects': '360'}, {'groupId': 'FG002', 'numSubjects': '361'}, {'groupId': 'FG003', 'numSubjects': '359'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '361'}, {'groupId': 'FG001', 'numSubjects': '358'}, {'groupId': 'FG002', 'numSubjects': '361'}, {'groupId': 'FG003', 'numSubjects': '358'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '345'}, {'groupId': 'FG001', 'numSubjects': '342'}, {'groupId': 'FG002', 'numSubjects': '335'}, {'groupId': 'FG003', 'numSubjects': '350'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The trial was conducted at 90 sites in 8 countries as follows: Brazil (3 sites), China (58 sites), Czech Republic (4 sites); Hong Kong (1 site), Romania (6 sites), Serbia (7 sites), Taiwan (4 sites), and South Africa (7 sites).', 'preAssignmentDetails': 'This was a 26-week, multicenter, multinational trial with four arms comparing efficacy and safety of oral semaglutide 3 milligram (mg), 7 mg and 14 mg once-daily with sitagliptin 100 mg once-daily. Out of 1441 participants randomized in the study, 1438 participants were exposed to trial product.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'BG000'}, {'value': '360', 'groupId': 'BG001'}, {'value': '361', 'groupId': 'BG002'}, {'value': '359', 'groupId': 'BG003'}, {'value': '1441', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants received semaglutide 3 mg tablet and placebo tablet matched to sitagliptin orally once daily for 26 weeks.'}, {'id': 'BG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 0 to week 4 and 7 mg from week 5 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'BG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants received oral semaglutide tablets once daily in a dose escalation manner from week 0 to week 26: 3 mg from week 1 to week 4, 7 mg from week 5 to week 8 and 14 mg from week 9 to week 26. Participants also received placebo matched to sitagliptin 100 mg for 26 weeks.'}, {'id': 'BG003', 'title': 'Sitagliptin 100 mg', 'description': 'Participants received oral sitagliptin 100 mg tablet and placebo tablet matched to oral semaglutide orally once daily for 26 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.5', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '53.4', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '53.5', 'spread': '10.5', 'groupId': 'BG002'}, {'value': '52.9', 'spread': '10.9', 'groupId': 'BG003'}, {'value': '53.3', 'spread': '10.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}, {'value': '601', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}, {'value': '203', 'groupId': 'BG003'}, {'value': '840', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '344', 'groupId': 'BG000'}, {'value': '341', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}, {'value': '341', 'groupId': 'BG003'}, {'value': '1372', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '272', 'groupId': 'BG000'}, {'value': '270', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}, {'value': '271', 'groupId': 'BG003'}, {'value': '1084', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'NA', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '264', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-28', 'size': 3896844, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-26T12:23', 'hasProtocol': True}, {'date': '2021-11-18', 'size': 713838, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-26T12:23', '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': 1441}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2019-07-11', 'resultsFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2019-07-11', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-28', 'studyFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%)', 'timeFrame': 'From baseline to week 26', 'description': 'Change in HbA1c from baseline to week 26 in percentage (%) point of HbA1c is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period and in-trial observation period. On-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. In-trial observation period: the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG)', 'timeFrame': 'From baseline to week 26', 'description': 'Change in fasting plasma glucose (FPG) from baseline to week 26 in millimole per liter (mmol/l) is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.'}, {'measure': 'Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in mean 7-point SMPG profile at week 26 is presented. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.'}, {'measure': 'Change From Baseline to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in 7-point SMPG: Mean postprandial increment (over all meals) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.'}, {'measure': 'Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no)', 'timeFrame': 'At week 26', 'description': 'Number of participants who achieved HbA1c \\<7.0% (53 mmol/mol) (ADA target) is presented in category "Yes" and participants who could not achieve HbA1C \\<7.0 (53 mmol/mol) (ADA target) is presented in category "No". The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.'}, {'measure': 'Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no)', 'timeFrame': 'At week 26', 'description': 'Number of participants who achieved HbA1c equal to or below 6.5 percent (48 mmol/mol) (AACE target) (yes/no) is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.'}, {'measure': 'Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no)', 'timeFrame': 'At week 26', 'description': 'Number of participants who achieved HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) (yes/no) is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.'}, {'measure': 'Time to Rescue Medication', 'timeFrame': 'From baseline to week 31', 'description': "Time to rescue medication is presented as the number of participants who had taken rescue medication anytime from baseline to week 31. 'Rescue medication': use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication."}, {'measure': 'Change From Baseline to Week 26 in Body Weight (Kilogram [kg])', 'timeFrame': 'From baseline to week 26', 'description': 'Change in body weight from baseline to week 26 in kg is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.'}, {'measure': 'Percentage Change From Baseline to Week 26 in Body Weight', 'timeFrame': 'From baseline to week 26', 'description': 'Percentage change from baseline to week 26 in body weight is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.'}, {'measure': 'Change From Baseline to Week 26 in Body Mass Index (BMI)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in BMI is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.'}, {'measure': 'Change From Baseline to Week 26 in Waist Circumference', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in waist circumference is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.'}, {'measure': 'Change From Baseline to Week 26 in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in total cholesterol (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.'}, {'measure': 'Change From Baseline to Week 26 in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in LDL cholesterol (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.'}, {'measure': 'Change From Baseline to Week 26 in Fasting Lipid Profile: Very-low-density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in VLDL cholesterol (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.'}, {'measure': 'Change From Baseline to Week 26 in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in HDL Cholesterol (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.'}, {'measure': 'Change From Baseline to Week 26 in Fasting Lipid Profile: Triglycerides (Ratio to Baseline)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in triglycerides (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.'}, {'measure': 'Change From Baseline to Week 26 in Fasting Lipid Profile: Free Fatty Acids (Ratio to Baseline)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in free fatty acids (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication.'}, {'measure': 'Change From Baseline to Week 26 in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey', 'timeFrame': 'From baseline to week 26', 'description': "SF-36 v2.0 is a 36-item, patient-reported survey of patient health. SF-36 measures the participant's overall Health Related Quality of Life on 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) and two component summary scores (physical component summary and mental component summary). Range of score for domains and component summary scores : 1-100 (Higher scores indicated a better health state). A positive change score indicates an improvement since baseline. Outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization up to end date which was first date of any of following: the last dose of trial product plus 3 days or initiation of rescue medication."}, {'measure': 'Number of Participants Who Achieved Body Weight Loss Equal to or Above 3 Percent (Yes/no)', 'timeFrame': 'At week 26', 'description': 'Number of participants who achieved body weight loss equal to or above 3 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.'}, {'measure': 'Number of Participants Who Achieved Body Weight Loss Equal to or Above 5 Percent (Yes/no)', 'timeFrame': 'At week 26', 'description': 'Number of participants who achieved body weight loss equal to or above 5 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.'}, {'measure': 'Number of Participants Who Achieved Body Weight Loss Equal to or Above 10 Percent (Yes/no)', 'timeFrame': 'At week 26', 'description': 'Number of participants who achieved body weight loss equal to or above 10 percent (yes/no). The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.'}, {'measure': 'Number of Participants Who Achieved HbA1c Below 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no)', 'timeFrame': 'At week 26', 'description': 'Number of participants who achieved HbA1c \\< 7.0 percent (53 mmol/mol) without hypoglycaemia (treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and no body weight gain (yes/no) at week 26 is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.'}, {'measure': 'Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) and Body Weight Loss Equal to or Above 3 Percent (Yes/no)', 'timeFrame': 'At week 26', 'description': 'Number of participants who achieved HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) and body weight loss equal to or above 3 percent (yes/no) is presented. The outcome data was evaluated based on In-trial observation period: This observation period represented the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. The in-trial observation period started at randomisation (as registered in the IWRS) and ended at the date of: The last direct participant-site contact, which was scheduled to take place 5 weeks after planned last dose of trial product at the follow-up visit; withdrawal for participants who withdrew their informed consent; The last participant-investigator contact as defined by the investigator for participants who were lost to follow-up; Death for participants who died before any of the above.'}, {'measure': 'Number of Treatment-emergent Adverse Events During Exposure to Trial Product', 'timeFrame': 'From baseline to week 31', 'description': 'An adverse event (AE) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. AEs with onset during the on-treatment period correspond to treatment-emergent AEs (TEAEs). The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product', 'timeFrame': 'From baseline to week 31', 'description': "Number of treatment-emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes during exposure to trial product is presented. Severe: requiring assistance from another person for recovery. 'BG-confirmed': hypoglycaemic episode with a plasma glucose value \\< 3.1 mmol/L (56 mg/dL); The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period."}, {'measure': 'Change From Baseline to Week 26 in Haematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in hematology parameters such as basophils, eosinophils, lymphocytes, monocytes, and neutrophils were reported. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Change From Baseline to Week 26 in Haematology Parameter: Haematocrit (Ratio to Baseline)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in Haematocrit at week 26 is reported as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Change From Baseline to Week 26 in Haematology Parameter: Haemoglobin (Ratio to Baseline)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in Haemoglobin at week 26 is reported as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Change From Baseline to Week 26 in Haematology Parameter: Leucocytes (Ratio to Baseline)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in Leucocytes at week 26 is reported as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Change From Baseline to Week 26 in Haematology Parameter: Thrombocytes (Ratio to Baseline)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in thrombocytes at week 26 is reported as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Change From Baseline to Week 26 in Biochemistry Parameter: Calcium (Total) (Ratio to Baseline)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in calcium (total) (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Change From Baseline to Week 26 in Biochemistry Parameter: Potassium (Ratio to Baseline)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in potassium (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Change From Baseline to Week 26 in Biochemistry Parameter: Sodium (Ratio to Baseline)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in sodium (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Change From Baseline to Week 26 in Biochemistry Parameter: Urea (Ratio to Baseline)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in urea (measured in mmol/L) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Change From Baseline to Week 26 in Biochemistry Parameter: Albumin (Ratio to Baseline)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in Albumin (measured in grams per deciliter \\[g/dL\\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Change From Baseline to Week 26 in Calcitonin (Ratio to Baseline)', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in calcitonin (measured in picograms per milliliter \\[pg/ml\\]) at week 26 is presented as ratio to baseline. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Change From Baseline to Week 26 in Vital Signs: Pulse Rate', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in pulse rate is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Change From Baseline to Week 26 in Vital Signs: Systolic Blood Pressure', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in systolic blood pressure is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Change From Baseline to Week 26 in Vital Signs: Diastolic Blood Pressure', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in diastolic blood pressure is presented. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Change From Baseline to Week 26 in Electrocardiogram (ECG) Category', 'timeFrame': 'From baseline to week 26', 'description': 'Change from baseline in ECG category at week 26 is presented. Change from baseline results are presented as shift in findings categorized as: normal, abnormal and not clinically significant (NCS), and abnormal and clinically significant (CS). The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Physical Examination Category', 'timeFrame': 'Baseline and week 26', 'description': 'The physical examination values for different body systems at baseline and week 26 are presented. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. The physical examination are presented for the following body systems: cardiovascular system; central and peripheral nervous system; gastrointestinal system, including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin; and thyroid gland. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Change From Baseline to Week 26 in Eye Examination Category', 'timeFrame': 'From baseline to week 26', 'description': 'The eye examination category at baseline and week 26 are presented. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period.'}, {'measure': 'Number of Participants With Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product', 'timeFrame': 'From baseline to week 31', 'description': "Number of participants with treatment-emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes during exposure to trial product is presented. Severe: requiring assistance from another person for recovery. 'BG-confirmed': hypoglycaemic episode with a plasma glucose value \\< 3.1 mmol/L (56 mg/dL); The outcome data was evaluated based on the on-treatment observation period: from date of first dose of trial product following randomization up to the first date of any of the following: follow-up visit, premature follow-up visit, last date on trial product plus 38 days or the end of the in-trial observation period."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '38985161', 'type': 'DERIVED', 'citation': 'Ji L, Agesen RM, Bain SC, Fu F, Gabery S, Geng J, Li Y, Lu Y, Luo B, Pang W, Tao Y; PIONEER 12 investigators. Efficacy and safety of oral semaglutide vs sitagliptin in a predominantly Chinese population with type 2 diabetes uncontrolled with metformin: PIONEER 12, a double-blind, Phase IIIa, randomised trial. Diabetologia. 2024 Sep;67(9):1800-1816. doi: 10.1007/s00125-024-06133-4. Epub 2024 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'This study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and sitagliptin (a medicine doctors can already prescribe). Participants will either get oral semaglutide or sitagliptin - which treatment is decided by chance. Participants will get 2 tablets a day to take first thing in the morning on an empty stomach. Only 1 tablet has study medicine in it. The other tablet is a dummy medicine (placebo). After taking the semaglutide tablet, participants may not eat or drink anything for at least 30 minutes. After the 30 minutes, participants must take the sitagliptin tablet. Then participants can have their first meal of the day and take any other medicines they may need, including their metformin. The study will last for about 7 months (33 weeks). Participants will have 8 clinic visits and 1 phone call with the study doctor. At all 8 of the clinic visits, participants will have blood samples taken.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.\n* Male or female, age above or equal to 18 years at the time of signing informed consent.\n\nFor Algeria only: Male or female, age above or equal to 19 years at the time of signing informed consent.\n\nFor Taiwan only: Male or female, age above or equal to 20 years at the time of signing informed consent\n\n* Diagnosed with type 2 diabetes mellitus 60 days or more prior to day of screening.\n* HbA1c between 7.0-10.5% (53-91 mmol/mol) (both inclusive).\n* Stable daily dose of metformin (equal to or above 1500 mg or maximum tolerated dose as documented in the subject medical record) 60 days or more prior to day of screening\n\nExclusion Criteria:\n\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (adequate contraceptive measure as required by local regulation or practice).\n* Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC). Family is defined as a first degree relative.\n* History or presence of pancreatitis (acute or chronic).\n* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).\n* Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation.\n* Subjects presently classified as being in New York Heart Association (NYHA) Class IV.\n* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.\n* Renal impairment measured as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m\\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).\n* Subjects with alanine aminotransferase (ALT) above 2.5 x upper limit of the normal (ULN).\n* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation. Fundus examination without dilation is only allowed if the digital camera used for fundus photography has this feature.\n* Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.'}, 'identificationModule': {'nctId': 'NCT04017832', 'acronym': 'PIONEER 12', 'briefTitle': 'A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus Treated With Metformin', 'orgStudyIdInfo': {'id': 'NN9924-4309'}, 'secondaryIdInfos': [{'id': 'U1111-1188-1256', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}, {'id': '2018-002589-38', 'type': 'REGISTRY', 'domain': 'European Medicines Agency (EudraCT)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral semaglutide 3 mg and placebo (sitagliptin)', 'description': 'Oral semaglutide tablets 3 mg and sitagliptin placebo tablets for 26 weeks', 'interventionNames': ['Drug: Oral semaglutide', 'Drug: Placebo (sitagliptin)']}, {'type': 'EXPERIMENTAL', 'label': 'Oral semaglutide 7 mg and placebo (sitagliptin)', 'description': 'Oral semaglutide tablets and sitagliptin placebo tablets. The dose of oral semaglutide will be escalated over 4 weeks, after which the target dose of 7 mg is taken for 22 weeks', 'interventionNames': ['Drug: Oral semaglutide', 'Drug: Placebo (sitagliptin)']}, {'type': 'EXPERIMENTAL', 'label': 'Oral semaglutide 14 mg and placebo (sitagliptin)', 'description': 'Oral semaglutide tablets and sitagliptin placebo tablets. The dose of oral semaglutide will be escalated over 8 weeks, after which the target dose of 14 mg is taken for 18 weeks', 'interventionNames': ['Drug: Oral semaglutide', 'Drug: Placebo (sitagliptin)']}, {'type': 'EXPERIMENTAL', 'label': 'Sitagliptin 100 mg and placebo (oral semaglutide)', 'description': 'Sitagliptin tablets and oral semaglutide placebo tablets for 26 weeks', 'interventionNames': ['Drug: Sitagliptin', 'Drug: Placebo (oral semaglutide)']}], 'interventions': [{'name': 'Oral semaglutide', 'type': 'DRUG', 'description': 'Oral semaglutide to be taken every morning in a fasting state, to be followed by sitagliptin placebo after 30 minutes. Only then participants can have their first meal of the day and their pre-study metformin tablets', 'armGroupLabels': ['Oral semaglutide 14 mg and placebo (sitagliptin)', 'Oral semaglutide 3 mg and placebo (sitagliptin)', 'Oral semaglutide 7 mg and placebo (sitagliptin)']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'description': 'Sitagliptin to be taken every morning, 30 minutes after taking the oral semaglutide placebo tablet. Then participants can have their first meal of the day and their pre-study metformin tablets', 'armGroupLabels': ['Sitagliptin 100 mg and placebo (oral semaglutide)']}, {'name': 'Placebo (oral semaglutide)', 'type': 'DRUG', 'description': 'Placebo tablet to be taken first thing in the morning', 'armGroupLabels': ['Sitagliptin 100 mg and placebo (oral semaglutide)']}, {'name': 'Placebo (sitagliptin)', 'type': 'DRUG', 'description': 'Placebo tablet to be taken 30 minutes after oral semaglutide', 'armGroupLabels': ['Oral semaglutide 14 mg and placebo (sitagliptin)', 'Oral semaglutide 3 mg and placebo (sitagliptin)', 'Oral semaglutide 7 mg and placebo (sitagliptin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16000', 'city': 'Algiers', 'country': 'Algeria', 'facility': 'Maison des diabétiques El Harrach', 'geoPoint': {'lat': 36.73225, 'lon': 3.08746}}, {'zip': '16003', 'city': 'Algiers', 'country': 'Algeria', 'facility': 'Department of internal medicine hospital (CHU) of BIRTRARIA', 'geoPoint': {'lat': 36.73225, 'lon': 3.08746}}, {'zip': '90430-001', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '01228-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'CPQuali Pesquisa Clínica Ltda', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '01228-200', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'CPCLIN - Centro de Pesquisas Clínicas', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Anhui Provincial Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '230061', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100144', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Shougang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '101200', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Pinggu Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400010', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Second Affliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '350025', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': '900th Hospital of Joint Logistics Support Force', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '362000', 'city': 'Quanzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 24.91389, 'lon': 118.58583}}, {'zip': '528399', 'city': 'Foshan', 'state': 'Guangdong', 'country': 'China', 'facility': 'Shunde Hospital of Southern Medical University', 'geoPoint': {'lat': 23.02677, 'lon': 113.13148}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen Memorial Hospital, Sun Yat-sen Universtiy', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '511400', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangzhou Panyu Central Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '516001', 'city': 'Huizhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Huizhou Central People's Hospital", 'geoPoint': {'lat': 23.11147, 'lon': 114.41523}}, {'zip': '515065', 'city': 'Shantou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The 2nd Affiliated Hospital of Shantou Uni Medical College', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}, {'zip': '061000', 'city': 'Cangzhou', 'state': 'Hebei', 'country': 'China', 'facility': "Cangzhou People's Hospital", 'geoPoint': {'lat': 38.31124, 'lon': 116.85334}}, {'zip': '053000', 'city': 'Hengshui', 'state': 'Hebei', 'country': 'China', 'facility': 'Harrison International Peace Hospital', 'geoPoint': {'lat': 37.73908, 'lon': 115.68348}}, {'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The Second Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '475000', 'city': 'Kaifeng', 'state': 'Henan', 'country': 'China', 'facility': 'Huaihe Hospital of Henan University', 'geoPoint': {'lat': 34.7986, 'lon': 114.30742}}, {'zip': '471003', 'city': 'Luoyang', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Henan university of Science', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'zip': '450004', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': "Zhengzhou First People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '442008', 'city': 'Shiyan', 'state': 'Hubei', 'country': 'China', 'facility': 'Taihe Hospital', 'geoPoint': {'lat': 32.6475, 'lon': 110.77806}}, {'zip': '430034', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Puai Hosptial', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410018', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Changsha Central Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '423000', 'city': 'Chenzhou', 'state': 'Hunan', 'country': 'China', 'facility': "Chenzhou No.1 People's Hospital", 'geoPoint': {'lat': 25.8, 'lon': 113.03333}}, {'zip': '421001', 'city': 'Hengyang', 'state': 'Hunan', 'country': 'China', 'facility': 'The First Affiliated Hospital Of University Of South China', 'geoPoint': {'lat': 26.88946, 'lon': 112.61888}}, {'zip': '412007', 'city': 'Zhuzhou', 'state': 'Hunan', 'country': 'China', 'facility': 'Zhuzhou Central Hospital', 'geoPoint': {'lat': 27.83333, 'lon': 113.15}}, {'zip': '213003', 'city': 'Changzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "Changzhou No.2 People's Hospital, Yanghu Branch", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}, {'zip': '213003', 'city': 'Changzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "The First People's Hospital of Changzhou", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}, {'zip': '210011', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '211106', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Jiangning Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '211166', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Sir Run Run Hospital Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '215004', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '214023', 'city': 'Wuxi', 'state': 'Jiangsu', 'country': 'China', 'facility': "Wuxi People's Hospital", 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'zip': '221002', 'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Affiliated Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'zip': '212001', 'city': 'Zhenjiang', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Affiliated Hospital of Jiangsu University', 'geoPoint': {'lat': 32.21086, 'lon': 119.45508}}, {'zip': '337055', 'city': 'Pingxiang', 'state': 'Jiangxi', 'country': 'China', 'facility': "Pingxiang People's Hospital", 'geoPoint': {'lat': 27.61672, 'lon': 113.85353}}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': "Jilin Province People's Hospital", 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '130033', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'China-Japan Union Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '130041', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'The Second Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '750004', 'city': 'Yinchuan', 'state': 'Ningxia', 'country': 'China', 'facility': 'General Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}, {'zip': '810007', 'city': 'Xining', 'state': 'Qinghai', 'country': 'China', 'facility': "Qinghai Provincial People's Hospital", 'geoPoint': {'lat': 36.62554, 'lon': 101.75739}}, {'zip': '710004', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': "The second Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '250013', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Jinan Central Hospital Affiliated to Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '266003', 'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'facility': 'The Affiliated Hospital of Qingdao Medical College', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'zip': '261041', 'city': 'Weifang', 'state': 'Shandong', 'country': 'China', 'facility': "Weifang People's Hospital", 'geoPoint': {'lat': 36.71, 'lon': 119.10194}}, {'zip': '201200', 'city': 'Pudong New District', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Pudong New Area People's Hospital"}, {'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Huashan Hospital, Affiliated to Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200065', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Tongji Hospital of Tongji university', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Tenth People's Hsopital, Tongji University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200120', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Dongfang Hospital Affiliated to Shanghai Tongji University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200240', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "The Fifth People's Hospital of Shanghai", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200336', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'General Hospital of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '300211', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'The Second Hospital of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '650032', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'First Affiated Hospital of Kunming Medical University', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '650032', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': "The First People's Hospital of Yunnan Province", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '650101', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Kunming Medical University', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The 2nd Affi Hosp of Zhejiang Univer School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '410013', 'city': 'Changsha', 'country': 'China', 'facility': 'The Third Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '63900', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Nemocnice milosrdnych bratri', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '537 01', 'city': 'Chrudim', 'country': 'Czechia', 'facility': 'DIAMIN', 'geoPoint': {'lat': 49.95109, 'lon': 15.79558}}, {'zip': '46001', 'city': 'Liberec', 'country': 'Czechia', 'facility': 'Interna a diabetologie MUDr. Vodickova', 'geoPoint': {'lat': 50.76711, 'lon': 15.05619}}, {'zip': '130 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'CCR Prague', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '140 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'MUDr. Michala Pelikanova', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Shatin, New Territories', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital'}, {'zip': '410025', 'city': 'Oradea', 'state': 'Bihor County', 'country': 'Romania', 'facility': 'SC Grand Med SRL', 'geoPoint': {'lat': 47.0458, 'lon': 21.91833}}, {'zip': '410151', 'city': 'Oradea', 'state': 'Bihor County', 'country': 'Romania', 'facility': 'S.C. Endodigest S.R.L.', 'geoPoint': {'lat': 47.0458, 'lon': 21.91833}}, {'zip': '300456', 'city': 'Timișoara', 'state': 'Timiș County', 'country': 'Romania', 'facility': 'SC Centru Medical Dr. Negrisanu SRL', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'zip': '13682', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'SC Nutrilife SRL', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '900591', 'city': 'Constanța', 'country': 'Romania', 'facility': 'Clinic of Diabetes Constanta', 'geoPoint': {'lat': 44.18073, 'lon': 28.63432}}, {'zip': '410169', 'city': 'Oradea', 'country': 'Romania', 'facility': 'Clinical County Emergency Hosp', 'geoPoint': {'lat': 47.0458, 'lon': 21.91833}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Hospital Centre Dragisa Misovic', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Endocrinology, Diabetes and Metabolism Diseases Clinic', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11080', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Hospital Centre Zemun', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '0083', 'city': 'Arcadia', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'GCT', 'geoPoint': {'lat': -25.7464, 'lon': 28.22137}}, {'zip': '1812', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Dr R Dulabh', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2001', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Newtown Clinical Research', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2193', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'WITS Clinical Research', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '1619', 'city': 'Kempton Park', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Clinresco Centres (Pty) Ltd', 'geoPoint': {'lat': -26.10859, 'lon': 28.2377}}, {'zip': '0152', 'city': 'Soshanguve', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Setshaba Research Centre', 'geoPoint': {'lat': -25.47288, 'lon': 28.09919}}, {'zip': '0250', 'city': 'Brits', 'state': 'North West', 'country': 'South Africa', 'facility': 'Armansis Medical Centre', 'geoPoint': {'lat': -25.63473, 'lon': 27.78022}}, {'zip': '7580', 'city': 'Kuilsriver', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Cape Town Medical Research Centre'}, {'zip': '7646', 'city': 'Paarl', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Paarl Reserch Centre', 'geoPoint': {'lat': -33.73378, 'lon': 18.97523}}, {'zip': '1449', 'city': 'Alberton', 'country': 'South Africa', 'facility': 'Union Hospital', 'geoPoint': {'lat': -26.26786, 'lon': 28.12225}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '114', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan', 'country': 'Taiwan', 'facility': 'Chang Gung Medical Foundation - Linko Branch', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}], 'overallOfficials': [{'name': 'Clinical Reporting Anchor and Disclosure (1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}