Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-02-26 @ 6:52 AM
Study NCT ID:
NCT03015220
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2017-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'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': 'C555680', 'term': 'dulaglutide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'phone': '(+1) 866-867-7178', 'title': 'Clinical Reporting Anchor and Disclosure (1452)', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Week 0 to week 57 (52 weeks treatment period + 5 weeks follow-up period). Results are based on the safety analysis set (SAS), which comprised all randomised participants who received at least one dose of trial product.', 'description': 'Serious adverse events and other AEs were based on the on-treatment observation period, i.e., the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. All-cause mortality were based on the in-trial observation period, i.e., the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'eventGroups': [{'id': 'EG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.', 'otherNumAtRisk': 131, 'deathsNumAtRisk': 131, 'otherNumAffected': 65, 'seriousNumAtRisk': 131, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.', 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 79, 'seriousNumAtRisk': 132, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 84, 'seriousNumAtRisk': 130, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 36, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 49, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 63, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 49, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 27, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Cardiac ablation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Ischaemic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}, {'term': 'Spinal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '330', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-57', 'description': 'Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Change in HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '1.0', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '0.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.23', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '-2.25', 'spread': '1.93', 'groupId': 'OG001'}, {'value': '-2.72', 'spread': '1.86', 'groupId': 'OG002'}, {'value': '-2.22', 'spread': '1.71', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.95', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '-1.96', 'spread': '1.72', 'groupId': 'OG001'}, {'value': '-2.18', 'spread': '2.50', 'groupId': 'OG002'}, {'value': '-1.80', 'spread': '1.71', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '2.3', 'groupId': 'OG002'}, {'value': '-2.9', 'spread': '2.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '2.4', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '2.6', 'groupId': 'OG002'}, {'value': '-2.6', 'spread': '2.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in mean 7-point SMPG profile was evaluated at weeks 26 and 52. 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. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '2.4', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '2.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '2.6', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '2.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '3.2', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '2.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '3.5', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '2.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in body weight was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '2.79', 'groupId': 'OG000'}, {'value': '-1.49', 'spread': '4.25', 'groupId': 'OG001'}, {'value': '-3.21', 'spread': '4.32', 'groupId': 'OG002'}, {'value': '0.25', 'spread': '3.33', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '3.28', 'groupId': 'OG000'}, {'value': '-1.34', 'spread': '4.77', 'groupId': 'OG001'}, {'value': '-2.33', 'spread': '4.67', 'groupId': 'OG002'}, {'value': '1.25', 'spread': '4.06', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '1.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in BMI was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Kilogram per square meter (kg/m^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '4.3', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '2.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '3.9', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '4.2', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '3.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Centimeters (cm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Total Cholesterol (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.96', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '12.3', 'groupId': 'OG001'}, {'value': '0.91', 'spread': '12.3', 'groupId': 'OG002'}, {'value': '0.92', 'spread': '8.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.98', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '13.3', 'groupId': 'OG001'}, {'value': '0.94', 'spread': '12.5', 'groupId': 'OG002'}, {'value': '0.93', 'spread': '11.4', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in fasting total cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Ratio of fasting total cholesterol', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.92', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '18.4', 'groupId': 'OG001'}, {'value': '0.87', 'spread': '20.7', 'groupId': 'OG002'}, {'value': '0.88', 'spread': '14.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.98', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '19.0', 'groupId': 'OG001'}, {'value': '0.92', 'spread': '18.6', 'groupId': 'OG002'}, {'value': '0.91', 'spread': '16.2', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in fasting low-density lipoprotein (LDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Ratio of fasting LDL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.02', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '12.8', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '12.5', 'groupId': 'OG002'}, {'value': '0.99', 'spread': '11.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '14.5', 'groupId': 'OG001'}, {'value': '1.01', 'spread': '13.1', 'groupId': 'OG002'}, {'value': '1.00', 'spread': '11.6', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in fasting high-density lipoprotein (HDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Ratio of fasting HDL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '37.9', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '32.3', 'groupId': 'OG001'}, {'value': '0.96', 'spread': '33.6', 'groupId': 'OG002'}, {'value': '0.93', 'spread': '33.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.90', 'spread': '33.3', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '39.4', 'groupId': 'OG001'}, {'value': '0.86', 'spread': '36.9', 'groupId': 'OG002'}, {'value': '0.88', 'spread': '31.6', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in fasting very-low density lipoprotein (VLDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Ratio of fasting VLDL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Triglyceride (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '41.1', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '34.1', 'groupId': 'OG001'}, {'value': '0.96', 'spread': '34.0', 'groupId': 'OG002'}, {'value': '0.93', 'spread': '33.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.89', 'spread': '33.9', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '43.0', 'groupId': 'OG001'}, {'value': '0.87', 'spread': '38.3', 'groupId': 'OG002'}, {'value': '0.88', 'spread': '30.8', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in fasting triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Ratio of fasting triglycerides', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26, week 52', 'description': 'Participants who achieved HbA1c below 7.0% (53 millimoles per mole \\[mmol/mol\\]) according to American Diabetes Association (ADA) target (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26, week 52', 'description': 'Participants who achieved HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) target (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26, week 52', 'description': 'Participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia episodes and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26, week 52', 'description': 'Participants who achieved HbA1c reduction more than or equal to 1% (10.9 mmol/mol) and weight loss more than or equal to 3% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26, week 52', 'description': 'Participants who achieved weight loss more than or equal to 5% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'No', 'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 26, week 52', 'description': 'Participants who achieved weight loss more than or equal to 10% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Time to Additional Anti-diabetic Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 0 to week 26', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Week 0 to week 52', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.2963', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '0.70', 'ciUpperLimit': '3.20', 'pValueComment': 'Unadjusted two-sided p-value for the test of no difference from 1.', 'estimateComment': 'Oral Semaglutide 3 mg\n\n/Dulaglutide 0.75 mg', 'groupDescription': 'Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'This hypothesis was not controlled for multiplicity.'}, {'pValue': '0.5997', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.83', 'pValueComment': 'Unadjusted two-sided p-value for the test of no difference from 1.', 'estimateComment': 'Oral Semaglutide 7 mg\n\n/Dulaglutide 0.75 mg', 'groupDescription': 'Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'This hypothesis was not controlled for multiplicity.'}, {'pValue': '0.1871', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.23', 'ciUpperLimit': '1.33', 'pValueComment': 'Unadjusted two-sided p-value for test of no difference from 1.', 'estimateComment': 'Oral Semaglutide 14 mg\n\n/Dulaglutide 0.75 mg', 'groupDescription': 'Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'This hypothesis was not controlled for multiplicity.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 0-52', 'description': 'Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment, 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 (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Time to Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 0 to week 26', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Week 0 to week 52', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.1672', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.90', 'ciLowerLimit': '0.76', 'ciUpperLimit': '4.72', 'pValueComment': 'Unadjusted two-sided p-value for test of no difference from 1.', 'estimateComment': 'Oral Semaglutide 3 mg\n\n/Dulaglutide 0.75 mg', 'groupDescription': 'Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'This hypothesis was not controlled for multiplicity.'}, {'pValue': '0.3391', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.21', 'ciUpperLimit': '1.72', 'pValueComment': 'Unadjusted two-sided p-value for test of no difference from 1.', 'estimateComment': 'Oral Semaglutide 7 mg\n\n/Dulaglutide 0.75 mg', 'groupDescription': 'Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'This hypothesis was not controlled for multiplicity.'}, {'pValue': '0.0110', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.62', 'pValueComment': 'Unadjusted two-sided p-value for test of no difference from 1.', 'estimateComment': 'Oral Semaglutide 14 mg\n\n/Dulaglutide 0.75 mg', 'groupDescription': 'Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'This hypothesis was not controlled for multiplicity.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 0-52', 'description': 'Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) 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. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants.'}, {'type': 'SECONDARY', 'title': 'Change in Amylase (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.01', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '18.1', 'groupId': 'OG001'}, {'value': '1.10', 'spread': '19.4', 'groupId': 'OG002'}, {'value': '1.05', 'spread': '23.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '23.8', 'groupId': 'OG001'}, {'value': '1.11', 'spread': '20.0', 'groupId': 'OG002'}, {'value': '1.07', 'spread': '18.8', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in amylase (measured as units per liter \\[U/L\\]) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.', 'unitOfMeasure': 'Ratio of amylase', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Lipase (Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.15', 'spread': '37.4', 'groupId': 'OG000'}, {'value': '1.27', 'spread': '35.8', 'groupId': 'OG001'}, {'value': '1.40', 'spread': '42.8', 'groupId': 'OG002'}, {'value': '1.14', 'spread': '48.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.11', 'spread': '34.7', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '50.3', 'groupId': 'OG001'}, {'value': '1.40', 'spread': '42.0', 'groupId': 'OG002'}, {'value': '1.15', 'spread': '57.7', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in lipase (measured as U/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.', 'unitOfMeasure': 'Ratio of lipase', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'spread': '9', 'groupId': 'OG000'}, {'value': '4', 'spread': '10', 'groupId': 'OG001'}, {'value': '4', 'spread': '9', 'groupId': 'OG002'}, {'value': '4', 'spread': '9', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'spread': '10', 'groupId': 'OG000'}, {'value': '3', 'spread': '9', 'groupId': 'OG001'}, {'value': '3', 'spread': '9', 'groupId': 'OG002'}, {'value': '2', 'spread': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.', 'unitOfMeasure': 'Beats per minute (beats/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Week 26: SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '13.0', 'groupId': 'OG001'}, {'value': '-6.0', 'spread': '15.0', 'groupId': 'OG002'}, {'value': '-4.0', 'spread': '12.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 52: SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '13.0', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '13.0', 'groupId': 'OG002'}, {'value': '-3.0', 'spread': '13.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 26: DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '9.0', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '10.0', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '11.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 52: DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '9.0', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '10.0', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '9.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in blood pressure (systolic blood pressure \\[SBP\\] and diastolic blood pressure \\[DBP\\]) was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.', 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in ECG Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Normal (week 0) to normal (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}]}, {'title': 'Normal (week 0) to abnormal NCS (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Normal (week 0) to abnormal CS (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal NCS (week 0) to normal (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal NCS (week 0) to abnormal NCS (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal NCS (week 0) to abnormal CS (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal CS (week 0) to normal (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal CS (week 0) to abnormal NCS (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal CS (week 0) to abnormal CS (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Normal (week 0) to normal (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}]}, {'title': 'Normal (week 0) to abnormal NCS (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Normal (week 0) to abnormal CS (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal (week 0) NCS to normal (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal (week 0) NCS to abnormal NCS (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal (week 0) NCS to abnormal CS (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal (week 0) CS to normal (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal (week 0) CS to abnormal NCS (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal (week 0) CS to abnormal CS (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Physical Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': '1) Cardiovascular system (week -2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '1) Cardiovascular system (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '1) Cardiovascular system (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '2) Central and peripheral nervous system (week -2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '2) Central and peripheral nervous system (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '2) Central and peripheral nervous system (week 56)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '3) Gastrointestinal system, incl. mouth (week -2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': '3) Gastrointestinal system, incl. mouth (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '3) Gastrointestinal system, incl. mouth (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '4.General appearance (week -2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '4.General appearance (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '4.General appearance (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '5.Head, ears, eyes, nose, throat, neck (week -2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': '5.Head, ears, eyes, nose, throat, neck (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': '5.Head, ears, eyes, nose, throat, neck (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': '6. Lymph node palpation (week -2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '6. Lymph node palpation (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '6. Lymph node palpation (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '7. Musculoskeletal system (week -2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '7. Musculoskeletal system (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': '7. Musculoskeletal system (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '8) Respiratory system (week -2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '8) Respiratory system (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '8) Respiratory system (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '9) Skin (week -2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '9) Skin (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '9) Skin (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '10) Thyroid gland (week -2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '10) Thyroid gland (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '10) Thyroid gland (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week -2, week 26, week 52', 'description': 'Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), week 26 and weeks 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Change in Eye Examination Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': 'Left eye (week -2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Left eye (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Right eye (week -2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Right eye (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}, {'title': 'Abnormal NCS', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Abnormal CS', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week -2, week 52', 'description': 'Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-57', 'description': 'Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.', 'unitOfMeasure': 'Episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 0-57', 'description': 'Participants with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 83 (78-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.'}, {'type': 'SECONDARY', 'title': 'Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': '1) Physical functioning (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.18', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '4.04', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '4.16', 'groupId': 'OG002'}, {'value': '-0.24', 'spread': '3.71', 'groupId': 'OG003'}]}]}, {'title': '1) Physical functioning (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.37', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '4.08', 'groupId': 'OG001'}, {'value': '-0.02', 'spread': '4.27', 'groupId': 'OG002'}, {'value': '-0.61', 'spread': '5.01', 'groupId': 'OG003'}]}]}, {'title': '2) Role Physical (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.58', 'spread': '5.12', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '5.49', 'groupId': 'OG001'}, {'value': '-1.01', 'spread': '6.00', 'groupId': 'OG002'}, {'value': '-0.48', 'spread': '5.22', 'groupId': 'OG003'}]}]}, {'title': '2) Role Physical (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.92', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '6.13', 'groupId': 'OG001'}, {'value': '-0.92', 'spread': '7.26', 'groupId': 'OG002'}, {'value': '-0.28', 'spread': '5.31', 'groupId': 'OG003'}]}]}, {'title': '3) Bodily Pain (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.88', 'spread': '8.39', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '8.26', 'groupId': 'OG001'}, {'value': '-0.99', 'spread': '9.32', 'groupId': 'OG002'}, {'value': '-0.44', 'spread': '7.25', 'groupId': 'OG003'}]}]}, {'title': '3) Bodily Pain (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.72', 'spread': '9.74', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '8.88', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '9.48', 'groupId': 'OG002'}, {'value': '0.24', 'spread': '5.77', 'groupId': 'OG003'}]}]}, {'title': '4)General Health (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.42', 'spread': '4.59', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '5.26', 'groupId': 'OG001'}, {'value': '0.71', 'spread': '5.94', 'groupId': 'OG002'}, {'value': '-1.03', 'spread': '5.28', 'groupId': 'OG003'}]}]}, {'title': '4)General Health (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'spread': '5.27', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '5.27', 'groupId': 'OG001'}, {'value': '0.59', 'spread': '6.13', 'groupId': 'OG002'}, {'value': '-0.97', 'spread': '6.63', 'groupId': 'OG003'}]}]}, {'title': '5) Vitality (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.62', 'spread': '7.49', 'groupId': 'OG000'}, {'value': '-0.79', 'spread': '7.08', 'groupId': 'OG001'}, {'value': '-0.83', 'spread': '6.84', 'groupId': 'OG002'}, {'value': '-1.40', 'spread': '7.94', 'groupId': 'OG003'}]}]}, {'title': '5) Vitality (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.90', 'spread': '7.29', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '7.03', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '6.83', 'groupId': 'OG002'}, {'value': '-0.86', 'spread': '7.63', 'groupId': 'OG003'}]}]}, {'title': '6) Social functioning (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.77', 'spread': '5.87', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '5.95', 'groupId': 'OG001'}, {'value': '-0.15', 'spread': '6.08', 'groupId': 'OG002'}, {'value': '0.15', 'spread': '4.98', 'groupId': 'OG003'}]}]}, {'title': '6) Social functioning (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.98', 'spread': '8.10', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '6.80', 'groupId': 'OG001'}, {'value': '-0.12', 'spread': '5.92', 'groupId': 'OG002'}, {'value': '-0.08', 'spread': '6.73', 'groupId': 'OG003'}]}]}, {'title': '7) Role emotional (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.54', 'spread': '7.87', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '6.96', 'groupId': 'OG001'}, {'value': '-1.16', 'spread': '6.60', 'groupId': 'OG002'}, {'value': '-1.01', 'spread': '6.28', 'groupId': 'OG003'}]}]}, {'title': '7) Role emotional (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.02', 'spread': '7.70', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '6.89', 'groupId': 'OG001'}, {'value': '-1.05', 'spread': '8.16', 'groupId': 'OG002'}, {'value': '-1.21', 'spread': '7.31', 'groupId': 'OG003'}]}]}, {'title': '8) Mental health (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.03', 'spread': '6.54', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '6.66', 'groupId': 'OG001'}, {'value': '-0.41', 'spread': '7.32', 'groupId': 'OG002'}, {'value': '0.27', 'spread': '7.34', 'groupId': 'OG003'}]}]}, {'title': '8) Mental health (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.64', 'spread': '7.63', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '6.68', 'groupId': 'OG001'}, {'value': '0.27', 'spread': '7.58', 'groupId': 'OG002'}, {'value': '-0.31', 'spread': '10.24', 'groupId': 'OG003'}]}]}, {'title': 'Physical component summary (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '4.19', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '4.27', 'groupId': 'OG001'}, {'value': '-0.23', 'spread': '5.24', 'groupId': 'OG002'}, {'value': '-0.57', 'spread': '4.80', 'groupId': 'OG003'}]}]}, {'title': 'Physical component summary (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.88', 'spread': '4.73', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '4.91', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '5.34', 'groupId': 'OG002'}, {'value': '-0.24', 'spread': '4.52', 'groupId': 'OG003'}]}]}, {'title': 'Mental component summary (week 26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.13', 'spread': '6.54', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '5.85', 'groupId': 'OG001'}, {'value': '-0.71', 'spread': '5.91', 'groupId': 'OG002'}, {'value': '-0.42', 'spread': '6.04', 'groupId': 'OG003'}]}]}, {'title': 'Mental component summary (week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.52', 'spread': '7.26', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '6.31', 'groupId': 'OG001'}, {'value': '-0.23', 'spread': '6.15', 'groupId': 'OG002'}, {'value': '-0.74', 'spread': '8.57', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 26, week 52', 'description': "SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}, {'type': 'SECONDARY', 'title': 'Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'OG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'classes': [{'title': '1.Burden on social and daily activities (W26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.44', 'spread': '17.59', 'groupId': 'OG000'}, {'value': '6.93', 'spread': '18.09', 'groupId': 'OG001'}, {'value': '4.88', 'spread': '16.46', 'groupId': 'OG002'}, {'value': '5.29', 'spread': '19.65', 'groupId': 'OG003'}]}]}, {'title': '1.Burden on social and daily activities (W52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.73', 'spread': '18.69', 'groupId': 'OG000'}, {'value': '6.81', 'spread': '18.85', 'groupId': 'OG001'}, {'value': '5.44', 'spread': '16.57', 'groupId': 'OG002'}, {'value': '3.99', 'spread': '19.25', 'groupId': 'OG003'}]}]}, {'title': '2.Anxiety and dissatisfaction with treatment(W26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.54', 'spread': '18.08', 'groupId': 'OG000'}, {'value': '10.94', 'spread': '17.83', 'groupId': 'OG001'}, {'value': '12.24', 'spread': '17.41', 'groupId': 'OG002'}, {'value': '9.24', 'spread': '20.87', 'groupId': 'OG003'}]}]}, {'title': '2.Anxiety and dissatisfaction with treatment(W52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.98', 'spread': '18.60', 'groupId': 'OG000'}, {'value': '9.93', 'spread': '19.61', 'groupId': 'OG001'}, {'value': '11.37', 'spread': '18.68', 'groupId': 'OG002'}, {'value': '3.14', 'spread': '19.79', 'groupId': 'OG003'}]}]}, {'title': '3.Hypoglycemia (W26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.18', 'spread': '20.62', 'groupId': 'OG000'}, {'value': '1.95', 'spread': '18.14', 'groupId': 'OG001'}, {'value': '2.67', 'spread': '21.14', 'groupId': 'OG002'}, {'value': '3.26', 'spread': '19.82', 'groupId': 'OG003'}]}]}, {'title': '3.Hypoglycemia (W52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.20', 'spread': '19.61', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '19.36', 'groupId': 'OG001'}, {'value': '3.87', 'spread': '20.70', 'groupId': 'OG002'}, {'value': '-0.66', 'spread': '23.10', 'groupId': 'OG003'}]}]}, {'title': '4.Satisfaction with treatment(W26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.67', 'spread': '19.08', 'groupId': 'OG000'}, {'value': '10.81', 'spread': '24.53', 'groupId': 'OG001'}, {'value': '14.29', 'spread': '28.11', 'groupId': 'OG002'}, {'value': '13.15', 'spread': '24.69', 'groupId': 'OG003'}]}]}, {'title': '4.Satisfaction with treatment(W52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.46', 'spread': '19.66', 'groupId': 'OG000'}, {'value': '7.88', 'spread': '23.92', 'groupId': 'OG001'}, {'value': '15.49', 'spread': '27.01', 'groupId': 'OG002'}, {'value': '6.35', 'spread': '26.22', 'groupId': 'OG003'}]}]}, {'title': 'Total score(W26)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.74', 'spread': '13.01', 'groupId': 'OG000'}, {'value': '7.88', 'spread': '14.40', 'groupId': 'OG001'}, {'value': '7.90', 'spread': '12.72', 'groupId': 'OG002'}, {'value': '7.18', 'spread': '15.56', 'groupId': 'OG003'}]}]}, {'title': 'Total score(W52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.31', 'spread': '13.47', 'groupId': 'OG000'}, {'value': '7.15', 'spread': '15.69', 'groupId': 'OG001'}, {'value': '8.25', 'spread': '12.81', 'groupId': 'OG002'}, {'value': '3.44', 'spread': '14.89', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 0, week 26, week 52', 'description': 'DTR-QoL questionnaire is a 29-item patient-reported survey of patient health that measures the influence of diabetes treatment on health related-QoL on 4 domains on individual scale ranges: "Burden on social activities and daily activities", "Anxiety and dissatisfaction with treatment", "Hypoglycemia" and "Satisfaction with treatment" on a 7-point graded response scale. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100 (best-case response = 100; worst case response = 0). The total score, after simple addition of the item scores, is converted to 0 - 100 (best-case response = 100; worst case response = 0). Change from baseline (week 0) in the scores were evaluated at week 26, week 52. Data based on in-trial observation period is presented. W26 and W52 refer to week 26 and week 52 respectively.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'FG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'FG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'FG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '132'}, {'groupId': 'FG002', 'numSubjects': '130'}, {'groupId': 'FG003', 'numSubjects': '65'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '132'}, {'groupId': 'FG002', 'numSubjects': '130'}, {'groupId': 'FG003', 'numSubjects': '65'}]}, {'type': 'Safety Analysis Set (SAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '132'}, {'groupId': 'FG002', 'numSubjects': '130'}, {'groupId': 'FG003', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '130'}, {'groupId': 'FG002', 'numSubjects': '127'}, {'groupId': 'FG003', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The trial was conducted at 36 sites in Japan.', 'preAssignmentDetails': 'Data presented in "participant flow" is based on the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '458', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Semaglutide 3 mg', 'description': 'Participants were to take oral semaglutide 3 mg tablets once-daily from week 0 to week 52. In addition, participants were to continue their pre-trial oral anti-diabetic drug (OAD) (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'BG001', 'title': 'Oral Semaglutide 7 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4 and 7 mg from week 4 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'BG002', 'title': 'Oral Semaglutide 14 mg', 'description': 'Participants were to take oral semaglutide tablets once-daily in a dose escalation manner from week 0 to week 52: 3 mg from week 0 to week 4, 7 mg from week 4 to week 8 and 14 mg from week 8 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'BG003', 'title': 'Dulaglutide 0.75 mg', 'description': 'Participants were to take dulaglutide 0.75 mg subcutaneous (under the skin) injections once-weekly from week 0 to week 52. In addition, participants were to continue their pre-trial OAD (either of sulphonylurea, glinide, thiazolidinedione, alpha-glucosidase inhibitor or SGLT-2 inhibitor) from week 0 to week 52.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '10', 'groupId': 'BG000'}, {'value': '58', 'spread': '11', 'groupId': 'BG001'}, {'value': '57', 'spread': '10', 'groupId': 'BG002'}, {'value': '61', 'spread': '9', 'groupId': 'BG003'}, {'value': '58', 'spread': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '117', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '341', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '458', '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 (NIH/OMB)', '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': '131', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '458', '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': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', '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'}], 'populationDescription': 'The FAS comprised of all randomised participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-15', 'size': 1212817, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-15T07:07', 'hasProtocol': True}, {'date': '2018-11-02', 'size': 508998, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-15T07:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 458}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'dispFirstSubmitDate': '2019-07-08', 'completionDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-11', 'studyFirstSubmitDate': '2017-01-06', 'dispFirstSubmitQcDate': '2019-07-08', 'resultsFirstSubmitDate': '2019-10-15', 'studyFirstSubmitQcDate': '2017-01-06', 'dispFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-06', 'studyFirstPostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Weeks 0-57', 'description': 'Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Change in Fasting Plasma Glucose', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in mean 7-point SMPG profile was evaluated at weeks 26 and 52. 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. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Change in Body Weight (kg)', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in body weight was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Change in Body Weight (%)', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Change in Body Mass Index (BMI)', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in BMI was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Change in Waist Circumference', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Change in Fasting Total Cholesterol (Ratio to Baseline)', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in fasting total cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline)', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in fasting low-density lipoprotein (LDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline)', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in fasting high-density lipoprotein (HDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline)', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in fasting very-low density lipoprotein (VLDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Change in Fasting Triglyceride (Ratio to Baseline)', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in fasting triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No)', 'timeFrame': 'Week 26, week 52', 'description': 'Participants who achieved HbA1c below 7.0% (53 millimoles per mole \\[mmol/mol\\]) according to American Diabetes Association (ADA) target (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No)', 'timeFrame': 'Week 26, week 52', 'description': 'Participants who achieved HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) target (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)', 'timeFrame': 'Week 26, week 52', 'description': 'Participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia episodes and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \\<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No)', 'timeFrame': 'Week 26, week 52', 'description': 'Participants who achieved HbA1c reduction more than or equal to 1% (10.9 mmol/mol) and weight loss more than or equal to 3% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No).', 'timeFrame': 'Week 26, week 52', 'description': 'Participants who achieved weight loss more than or equal to 5% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No)', 'timeFrame': 'Week 26, week 52', 'description': 'Participants who achieved weight loss more than or equal to 10% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Time to Additional Anti-diabetic Medication', 'timeFrame': 'Weeks 0-52', 'description': 'Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment, 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 (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Time to Rescue Medication', 'timeFrame': 'Weeks 0-52', 'description': 'Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) 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. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.'}, {'measure': 'Change in Amylase (Ratio to Baseline)', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in amylase (measured as units per liter \\[U/L\\]) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.'}, {'measure': 'Change in Lipase (Ratio to Baseline)', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in lipase (measured as U/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.'}, {'measure': 'Change in Pulse Rate', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.'}, {'measure': 'Change in Blood Pressure', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in blood pressure (systolic blood pressure \\[SBP\\] and diastolic blood pressure \\[DBP\\]) was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.'}, {'measure': 'Change in ECG Evaluation', 'timeFrame': 'Week 0, week 26, week 52', 'description': 'Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Change in Physical Examination', 'timeFrame': 'Week -2, week 26, week 52', 'description': 'Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), week 26 and weeks 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.'}, {'measure': 'Change in Eye Examination Category', 'timeFrame': 'Week -2, week 52', 'description': 'Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.'}, {'measure': 'Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes', 'timeFrame': 'Weeks 0-57', 'description': 'Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.'}, {'measure': 'Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes', 'timeFrame': 'Weeks 0-57', 'description': 'Participants with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 83 (78-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \\<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.'}, {'measure': 'Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)', 'timeFrame': 'Week 0, week 26, week 52', 'description': "SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period."}, {'measure': 'Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains', 'timeFrame': 'week 0, week 26, week 52', 'description': 'DTR-QoL questionnaire is a 29-item patient-reported survey of patient health that measures the influence of diabetes treatment on health related-QoL on 4 domains on individual scale ranges: "Burden on social activities and daily activities", "Anxiety and dissatisfaction with treatment", "Hypoglycemia" and "Satisfaction with treatment" on a 7-point graded response scale. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100 (best-case response = 100; worst case response = 0). The total score, after simple addition of the item scores, is converted to 0 - 100 (best-case response = 100; worst case response = 0). Change from baseline (week 0) in the scores were evaluated at week 26, week 52. Data based on in-trial observation period is presented. W26 and W52 refer to week 26 and week 52 respectively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '33460016', 'type': 'RESULT', 'citation': 'Ishii H, Hansen BB, Langer J, Horio H. Effect of Orally Administered Semaglutide Versus Dulaglutide on Diabetes-Related Quality of Life in Japanese Patients with Type 2 Diabetes: The PIONEER 10 Randomized, Active-Controlled Trial. Diabetes Ther. 2021 Feb;12(2):613-623. doi: 10.1007/s13300-020-00985-w. Epub 2021 Jan 18.'}, {'pmid': '32333876', 'type': 'RESULT', 'citation': 'Yabe D, Nakamura J, Kaneto H, Deenadayalan S, Navarria A, Gislum M, Inagaki N; PIONEER 10 Investigators. Safety and efficacy of oral semaglutide versus dulaglutide in Japanese patients with type 2 diabetes (PIONEER 10): an open-label, randomised, active-controlled, phase 3a trial. Lancet Diabetes Endocrinol. 2020 May;8(5):392-406. doi: 10.1016/S2213-8587(20)30074-7.'}, {'pmid': '32998732', 'type': 'DERIVED', 'citation': 'Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.'}, {'pmid': '32267058', 'type': 'DERIVED', 'citation': 'Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13.'}, {'pmid': '31903692', 'type': 'DERIVED', 'citation': 'Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Asia. The aim of this trial is to investigate Safety and efficacy of oral semaglutide versus dulaglutide both in combination with one OAD (oral antidiabetic drug) in Japanese subjects with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 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* Japanese male or female, age above or equal to 20 years at the time of signing informed consent\n* Diagnosed with type 2 diabetes mellitus for at least 60 days prior to day of screening\n* HbA1c (glycosylated haemoglobin) between 7.0%-10.5% (53-91 mmol/mol) (both inclusive)\n* OAD (oral antidiabetic drug) monotherapy with stable daily dose for at least 60 days prior to the day of screening of one of SU (sulphonylurea) glinide , TZD (thiazolidinedione), α-GI (alpha-glucosidase inhibitor) or SGLT-2 (sodium-glucose cotransporter-2) inhibitor according to Japanese labelling\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 an adequate contraceptive method. Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives\n* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol\n* Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)\n* History 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 or hospitalisation for unstable angina or transient ischaemic attack (TIA) 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* Subjects with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL)\n* Renal impairment defined as estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)\n* Treatment with once-weekly glucagon-like peptide-1 receptor agonists (GLP-1 RA) or once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor in a period of 90 days before the day of screening\n* For subjects treated with an OAD other than TZD at screening: Treatment with TZD in a period of 90 days before the day of screening\n* Treatment with any medication for the indication of diabetes or obesity in addition to background OAD medication (SU, glinide, TZD, α-GI or SGLT-2 inhibitor) in a period of 60 days before the day of screening with the exception of short-term insulin treatment for acute illness for a total of at least 14 days\n* Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation\n* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in situ carcinomas)\n* History of diabetic ketoacidosis"}, 'identificationModule': {'nctId': 'NCT03015220', 'acronym': 'PIONEER 10', 'briefTitle': 'Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD in Japanese Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NN9924-4282'}, 'secondaryIdInfos': [{'id': 'U1111-1181-4133', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'JapicCTI-173485', 'type': 'OTHER', 'domain': 'Japic'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral semaglutide 3 mg', 'interventionNames': ['Drug: Semaglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Oral semaglutide 7 mg', 'interventionNames': ['Drug: Semaglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Oral semaglutide 14 mg', 'interventionNames': ['Drug: Semaglutide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dulaglutide 0.75 mg', 'interventionNames': ['Drug: Dulaglutide']}], 'interventions': [{'name': 'Semaglutide', 'type': 'DRUG', 'description': 'Oral administration once-daily, as add-on to pre-trial oral antidiabetic drug (OAD).', 'armGroupLabels': ['Oral semaglutide 14 mg', 'Oral semaglutide 3 mg', 'Oral semaglutide 7 mg']}, {'name': 'Dulaglutide', 'type': 'DRUG', 'description': 'Subcutaneously administration (s.c., under the skin) once-weekly, as add-on to pre-trial oral antidiabetic drug (OAD).', 'armGroupLabels': ['Dulaglutide 0.75 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '123-0845', 'city': 'Adachi-ku, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '379-0116', 'city': 'Annaka-shi, Gunma', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '116-0012', 'city': 'Arakawa-ku, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '260-0804', 'city': 'Chiba-shi, Chiba', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '104-0061', 'city': 'Chuo-ku, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '963-8851', 'city': 'Fukushima', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'zip': '373-0036', 'city': 'Gunma', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '311-0113', 'city': 'Ibaraki', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'zip': '358-0011', 'city': 'Iruma-shi, Saitama', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '232-0064', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '582-0005', 'city': 'Kashiwara-shi, Osaka', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '350-0851', 'city': 'Kawagoe-shi, Saitama', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '332-8558', 'city': 'Kawaguchi-shi, Saitama', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '862-0976', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '701-0192', 'city': 'Kurashiki-shi, Okayama', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '601-1495', 'city': 'Kyoto-shi, Kyoto', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '181-0013', 'city': 'Mitaka-shi, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '310-0826', 'city': 'Mito-shi, Ibaraki', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '880-0034', 'city': 'Miyazaki', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'zip': '569-1045', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '144-0051', 'city': 'Ota-ku, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '062 0007', 'city': 'Sapporo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '004-0004', 'city': 'Sapporo-shi, Hokkaido', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '980-0021', 'city': 'Sendai-shi, Miyagi', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '329-0433', 'city': 'Shimotsuke-shi, Tochigi', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}, {'zip': '141-0032', 'city': 'Shinagawa-ku, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '424-0853', 'city': 'Shizuoka-shi, Shizuoka', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '565-0853', 'city': 'Suita-shi, Osaka', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '103-0027', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '104-0031', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '125-0054', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '160-0008', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '171-0021', 'city': 'Toshima-ku, Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '242-0004', 'city': 'Yamato-shi, Kanagawa', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com/', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitent on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}