Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT05362058
Status:
COMPLETED
Last Update Posted:
2025-05-16
First Post:
2022-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}}}}, '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': 'C571886', 'term': 'insulin degludec'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'As prespecified in the statistical analysis plan, outcome analyses related to Continuous Glucose Monitoring (CGM) were conducted using data from the Dexcom G6 system, which was used at all study sites except those in China. In China, CGM data were collected using the Libre FreeStyle H system.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline to end of follow-up (up to 57 weeks)', 'description': '* All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received.\n* Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.', 'otherNumAtRisk': 466, 'deathsNumAtRisk': 466, 'otherNumAffected': 195, 'seriousNumAtRisk': 466, 'deathsNumAffected': 2, 'seriousNumAffected': 41}, {'id': 'EG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.', 'otherNumAtRisk': 462, 'deathsNumAtRisk': 462, 'otherNumAffected': 224, 'seriousNumAtRisk': 462, 'deathsNumAffected': 1, 'seriousNumAffected': 38}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 36, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 48, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 29, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 38, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 51, 'numAffected': 51}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 31, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 50, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 50, 'numAffected': 41}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 52, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 63, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 35, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Drug titration error', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 58, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 86, 'numAffected': 55}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 30, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 30, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 47, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac ventricular thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Microvascular coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Retinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rhegmatogenous retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Intestinal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chronic tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Covid-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pilonidal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Traumatic renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chondropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Benign spleen tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Clear cell renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Colorectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diffuse large b-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hormone receptor positive breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pancreatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypoglycaemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Peripheral nerve lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abnormal uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 281, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac pacemaker insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Coronary artery bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 466, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 462, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '463', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.26', 'spread': '0.0470', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '0.0473', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.04', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': '0.4% noninferiority margin (NIM)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': '* HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.\n* Least Squares (LS) mean was determined using Analysis of Covariance (ANCOVA) model with Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of the study drug and had HbA1c measurement at baseline or Week 52. Participants who discontinued the study drug due to inadvertent enrollment were excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c at Week 52 in Participants Using GLP-1 Receptor Agonists [Noninferiority Analysis]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.26', 'spread': '0.0699', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '0.0696', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': '0.4% noninferiority margin (NIM)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': '* HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.\n* LS mean was determined using ANCOVA model with Baseline + Country + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who continued using GLP-1 receptor agonists and received at least one dose of the study drug, had HbA1c measurement at baseline or Week 52. Participants who discontinued the study drug due to inadvertent enrollment were excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c at Week 52 in Participants Not Using GLP-1 Receptor Agonists [Noninferiority Analysis]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.26', 'spread': '0.0627', 'groupId': 'OG000'}, {'value': '-1.15', 'spread': '0.0639', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.07', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': '0.4% noninferiority margin (NIM)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': '* HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.\n* LS mean was determined using ANCOVA model with Baseline + Country + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who were not using GLP-1 receptor agonists and received at least one dose of the study drug, had HbA1c measurement at baseline or Week 52. Participants who discontinued the study drug due to inadvertent enrollment were excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c at Week 52 [Superiority Analysis]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '463', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.26', 'spread': '0.0470', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '0.0473', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.188', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.04', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': '* HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.\n* LS mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of the study drug and had HbA1c measurement at baseline or Week 52. Participants who discontinued the study drug due to inadvertent enrollment were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] - Week 48 to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.27', 'spread': '1.076', 'groupId': 'OG000'}, {'value': '61.18', 'spread': '1.085', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.09', 'ciLowerLimit': '0.09', 'ciUpperLimit': '6.08', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 48 to Week 52', 'description': '* Percentage of time spent within the blood glucose range of 70 to 180 milligrams per deciliter (mg/dL) \\[3.9 to 10.0 millimoles per liter (mmol/L)\\], as measured during the continuous glucose monitoring (CGM) session over a 24-hour period, from Week 48 to Week 52.\n* LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed using multiple imputation under the assumption of missing at random, while missing data at Week 48-52 were imputed using a return-to-baseline multiple imputation approach.', 'unitOfMeasure': 'Percentage of time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least 1 dose of the study drug and had CGM data collected using the Dexcom G6 system at baseline or Week 48-52 were included. Participants who discontinued the study drug due to inadvertent enrollment were excluded. As pre-specified in the statistical analysis plan, outcome data were analyzed only from CGM data collected by the Dexcom G6 system.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c at Week 26 [Superiority Analysis]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '463', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.37', 'spread': '0.0394', 'groupId': 'OG000'}, {'value': '-1.30', 'spread': '0.0397', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.260', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': '* HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.\n* LS mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of the study drug and had HbA1c measurement at baseline or Week 26. Participants who discontinued the study drug due to inadvertent enrollment were excluded.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] - Week 22 to Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '382', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.12', 'spread': '0.991', 'groupId': 'OG000'}, {'value': '65.85', 'spread': '0.990', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.848', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-2.48', 'ciUpperLimit': '3.02', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 22 to Week 26', 'description': '* Percentage of time spent within the blood glucose range of 70 to 180 mg/dL (3.9 to 10.0 mmol/L), as measured during the CGM session over a 24-hour period, from Week 22 to Week 26.\n* LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed using multiple imputation under the assumption of missing at random, while missing data at Week 22-26 were imputed using a return-to-baseline multiple imputation approach.', 'unitOfMeasure': 'Percentage of time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least 1 dose of the study drug and had CGM data collected using the Dexcom G6 system at baseline or Week 22-26 were included. Participants who discontinued the study drug due to inadvertent enrollment were excluded. As pre-specified in the statistical analysis plan, outcome data were analyzed only from CGM data collected by the Dexcom G6 system.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Blood Glucose (FBG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '458', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'title': 'Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '458', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-57.86', 'spread': '1.491', 'groupId': 'OG000'}, {'value': '-63.04', 'spread': '1.500', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '458', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-59.77', 'spread': '1.400', 'groupId': 'OG000'}, {'value': '-59.97', 'spread': '1.405', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.18', 'ciLowerLimit': '1.06', 'ciUpperLimit': '9.30', 'groupDescription': 'Week 26 (Statistical Analysis) - LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at week 26 were imputed by return-to-baseline multiple imputations approach.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.918', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '-3.65', 'ciUpperLimit': '4.06', 'groupDescription': 'Week 52 (Statistical Analysis) - LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at week 52 were imputed by return-to-baseline multiple imputations approach.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26, Week 52', 'description': 'Change from baseline in fasting blood glucose measured by self-monitoring blood glucose (SMBG).', 'unitOfMeasure': 'Milligram per deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of the study drug and had evaluable data for this outcome at Baseline, Week 26, or Week 52 were included.For the Week 26 analysis data from Baseline and Week 26 were used and for Week 52 analysis data from Baseline and Week 52 data were used.Participants who discontinued the study drug due to inadvertent enrollment were excluded.'}, {'type': 'SECONDARY', 'title': 'Glucose Variability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'title': 'Week 22 to Week 26', 'categories': [{'measurements': [{'value': '26.31', 'spread': '0.250', 'groupId': 'OG000'}, {'value': '26.67', 'spread': '0.251', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 to Week 52', 'categories': [{'measurements': [{'value': '26.29', 'spread': '0.243', 'groupId': 'OG000'}, {'value': '26.81', 'spread': '0.246', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.310', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '0.34', 'groupDescription': 'Week 22 to Week 26 (Statistical Analysis)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.138', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '0.17', 'groupDescription': 'Week 48 to Week 52 (Statistical Analysis)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 22 to Week 26 and Week 48 to Week 52', 'description': '* Glucose variability measured as coefficient of variation (CV) for blood glucose during the CGM session over a 24-hour period, between Week 22 to Week 26 and Week 48 to Week 52 was reported.\n* LS mean was determined using Mixed Model Repeated Measures (MMRM) model with Baseline + Country +HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'Percentage of CV', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least 1 dose of the study drug and had Dexcom G6 system CGM data collected at baseline and at least 1 post-baseline value were included. Participants who discontinued the study drug due to inadvertent enrollment were excluded. As pre-specified in the statistical analysis plan, outcome data were analyzed only from CGM data collected by the Dexcom G6 system.'}, {'type': 'SECONDARY', 'title': 'Basal Insulin Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '463', 'groupId': 'OG000'}, {'value': '457', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'title': 'Week 26', 'categories': [{'measurements': [{'value': '292.8', 'spread': '6.30', 'groupId': 'OG000'}, {'value': '305.9', 'spread': '6.17', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '314.7', 'spread': '6.25', 'groupId': 'OG000'}, {'value': '334.4', 'spread': '6.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.136', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.2', 'ciLowerLimit': '-30.5', 'ciUpperLimit': '4.1', 'groupDescription': 'Week 26 (Statistical Analysis)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.7', 'ciLowerLimit': '-37.0', 'ciUpperLimit': '-2.4', 'groupDescription': 'Week 52 (Statistical Analysis)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26 and Week 52', 'description': "* The insulin dose was calculated based on the participant's entry of daily or weekly insulin doses in an electronic diary. The average weekly basal insulin dose at Week 26 and Week 52 was reported.\n* LS mean was determined using MMRM model with Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.", 'unitOfMeasure': 'Units per week (U/week)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of the study drug and had a baseline and at least one post-baseline value for this outcome. Participants who discontinued the study drug due to inadvertent enrollment were excluded.'}, {'type': 'SECONDARY', 'title': 'Hypoglycemia Event Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.58', 'spread': '0.062', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.058', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.111', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.78', 'statisticalMethod': 'Negative binomial model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 52', 'description': '* A hypoglycemic event with blood glucose (BG) levels of less than (\\<) 54 mg/dL (3.0 mmol/L) \\[Level 2\\] or Severe Hypoglycemia \\[Level 3\\] was reported. A severe hypoglycemic event was characterized by altered mental or physical status, requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia.\n* Group mean was reported and determined by Negative binomial model using Number of episodes = HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.', 'unitOfMeasure': 'Events per participant-year of exposure', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Nocturnal Hypoglycemia Event Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.018', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.983', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.89', 'statisticalMethod': 'Negative binomial model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 52', 'description': '* The event rate of participant-reported clinically significant nocturnal hypoglycemia (defined as blood glucose level \\<54 mg/dL (3.0 mmol/L) or severe hypoglycemia and occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment phase up to week 52.\n* Group mean was reported and determined by Negative binomial model using Number of episodes = HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.', 'unitOfMeasure': 'Events per participant-year of exposure', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '465', 'groupId': 'OG000'}, {'value': '461', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'title': 'Week 26', 'categories': [{'measurements': [{'value': '3.16', 'spread': '0.158', 'groupId': 'OG000'}, {'value': '2.66', 'spread': '0.158', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '3.60', 'spread': '0.158', 'groupId': 'OG000'}, {'value': '3.54', 'spread': '0.159', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.064', 'ciUpperLimit': '0.94', 'groupDescription': 'Week 26 (Statistical Analysis)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.801', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.056', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.50', 'groupDescription': 'Week 52 (Statistical Analysis)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26, Week 52', 'description': 'Change from baseline in body weight was reported. LS mean was determined by MMRM model with Baseline + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'Kilogram (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome were included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time in Hypoglycemia Range With Blood Glucose <70 mg/dL (3.9 mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'title': 'Week 8 to Week 12', 'categories': [{'measurements': [{'value': '1.06', 'spread': '0.101', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '0.103', 'groupId': 'OG001'}]}]}, {'title': 'Week 22 to Week 26', 'categories': [{'measurements': [{'value': '1.55', 'spread': '0.137', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '0.137', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 to Week 52', 'categories': [{'measurements': [{'value': '1.49', 'spread': '0.150', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '0.152', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.374', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.41', 'groupDescription': 'Week 8 to Week 12 (Statistical Analysis)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.130', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.67', 'groupDescription': 'Week 22 to Week 26 (Statistical Analysis)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.162', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.72', 'groupDescription': 'Week 48 to Week 52 (Statistical Analysis)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52', 'description': '* Percentage of time spent in the hypoglycemia range with blood glucose \\<70 mg/dL (3.9 mmol/L), as measured during the CGM session over a 24-hour period from Week 8 to Week 12, Week 22 to Week 26, and Week 48 to Week 52 was reported.\n* LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'Percentage of time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least 1 dose of the study drug and had Dexcom G6 system CGM data collected at baseline and at least 1 post-baseline value were included. Participants who discontinued the study drug due to inadvertent enrollment were excluded. As pre-specified in the statistical analysis plan, outcome data were analyzed only from CGM data collected by the Dexcom G6 system.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time in Hypoglycemia Range With Blood Glucose <54 mg/dL (3.0 mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'title': 'Week 8 to Week 12', 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.041', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.041', 'groupId': 'OG001'}]}]}, {'title': 'Week 22 to Week 26', 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.037', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 to Week 52', 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.043', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.043', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.594', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.08', 'groupDescription': 'Week 8 to Week 12 (Statistical Analysis)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.266', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.16', 'groupDescription': 'Week 22 to Week 26 (Statistical Analysis)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.791', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.14', 'groupDescription': 'Week 48 to Week 52 (Statistical Analysis)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52', 'description': '* Percentage of time spent in the hypoglycemia range with blood glucose \\< 54 mg/dL (3.0 mmol/L), as measured during the CGM session over a 24-hour period from Week 8 to Week 12, Week 22 to Week 26, and Week 48 to Week 52, was reported.\n* LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'Percentage of time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least 1 dose of the study drug and had Dexcom G6 system CGM data collected at baseline and at least 1 post-baseline value were included. Participants who discontinued the study drug due to inadvertent enrollment were excluded. As pre-specified in the statistical analysis plan, outcome data were analyzed only from CGM data collected by the Dexcom G6 system.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time in Hyperglycemia Range With Blood Glucose >180 mg/dL (10.0 mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'title': 'Week 8 to Week 12', 'categories': [{'measurements': [{'value': '31.99', 'spread': '0.925', 'groupId': 'OG000'}, {'value': '32.40', 'spread': '0.939', 'groupId': 'OG001'}]}]}, {'title': 'Week 22 to Week 26', 'categories': [{'measurements': [{'value': '28.93', 'spread': '0.999', 'groupId': 'OG000'}, {'value': '29.87', 'spread': '1.007', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 to Week 52', 'categories': [{'measurements': [{'value': '29.66', 'spread': '1.074', 'groupId': 'OG000'}, {'value': '33.05', 'spread': '1.086', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.757', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-3.00', 'ciUpperLimit': '2.18', 'groupDescription': 'Week 8 to Week 12 (Statistical Analysis)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.511', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.93', 'ciLowerLimit': '-3.72', 'ciUpperLimit': '1.85', 'groupDescription': 'Week 22 to Week 26 (Statistical Analysis)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.39', 'ciLowerLimit': '-6.39', 'ciUpperLimit': '-0.39', 'groupDescription': 'Week 48 to Week 52 (Statistical Analysis)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52', 'description': '* Percentage of time spent in the hyperglycemia range with blood glucose greater than (\\>) 180 mg/dL (10.0 mmol/L), as measured during the CGM session over a 24-hour period from Week 8 to Week 12, Week 22 to Week 26, and Week 48 to Week 52 was reported.\n* LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'unitOfMeasure': 'Percentage of time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least 1 dose of the study drug and had Dexcom G6 system CGM data collected at baseline and at least 1 post-baseline value were included. Participants who discontinued the study drug due to inadvertent enrollment were excluded. As pre-specified in the statistical analysis plan, outcome data were analyzed only from CGM data collected by the Dexcom G6 system.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Treatment-Related Impact Measures for Diabetes (TRIM-D) -Total Score at Week 26 and Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '444', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'title': 'Week 26', 'categories': [{'measurements': [{'value': '8.84', 'spread': '0.507', 'groupId': 'OG000'}, {'value': '7.18', 'spread': '0.507', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '8.82', 'spread': '0.519', 'groupId': 'OG000'}, {'value': '6.81', 'spread': '0.517', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.66', 'ciLowerLimit': '0.26', 'ciUpperLimit': '3.07', 'groupDescription': 'Week 26 (Statistical Analysis)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.00', 'ciLowerLimit': '0.57', 'ciUpperLimit': '3.44', 'groupDescription': 'Week 52 (Statistical Analysis)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26, Week 52', 'description': "* The TRIM-D is a participant-reported measure designed to assess the impact of diabetes treatment on individuals' functioning and well-being across different diabetes treatments. The questionnaire includes 28 items grouped into 5 sub-domains: treatment burden, daily life, diabetes management, compliance, and psychological health. Each item is assessed on a 5-point scale, with higher scores indicating better health status. All items were summed to obtain a total raw score, which was transformed to a scale of 0 to 100 to obtain a total score. The total score range is 0-100, with a higher total score indicating better overall health and well-being, while a lower total score indicates worse health or well-being.\n* LS mean was determined using MMRM model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.Participants who discontinued the study drug due to inadvertent enrollment were excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores at Week 26 and Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'title': 'Physical Component Score at Week 26', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.344', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.345', 'groupId': 'OG001'}]}]}, {'title': 'Mental Component Score at Week 26', 'categories': [{'measurements': [{'value': '0.018', 'spread': '0.380', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.381', 'groupId': 'OG001'}]}]}, {'title': 'Physical Component Score at Week 52', 'categories': [{'measurements': [{'value': '0.027', 'spread': '0.349', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.351', 'groupId': 'OG001'}]}]}, {'title': 'Mental Component Score at Week 52', 'categories': [{'measurements': [{'value': '0.014', 'spread': '0.386', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.389', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.638', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '0.63', 'groupDescription': 'Physical Component Score at Week 26 (Statistical Analysis) -LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.499', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-1.24', 'ciUpperLimit': '0.60', 'groupDescription': 'Mental Component Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.695', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '1.01', 'groupDescription': 'Physical Component Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.626', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-1.17', 'ciUpperLimit': '0.71', 'groupDescription': 'Mental Component Score at Week 52 (Statistical Analysis) -LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26, Week 52', 'description': 'The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Each domain is scored individually, and information from these 8 domains is further aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.Participants who discontinued the study drug due to inadvertent enrollment were excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQuality of Life (EuroQol) - 5 Dimensions-5 Levels (EQ-5D-5L) Health State Index and EQ Visual Analog Scale (VAS) Scores at Week 26 and Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'classes': [{'title': 'EQ-5D-5L Health State Index Score at Week 26', 'categories': [{'measurements': [{'value': '-0.018', 'spread': '0.0078', 'groupId': 'OG000'}, {'value': '-0.004', 'spread': '0.0078', 'groupId': 'OG001'}]}]}, {'title': 'EQ VAS Score at Week 26', 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.701', 'groupId': 'OG000'}, {'value': '2.18', 'spread': '0.699', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D-5L Health State Index Score at Week 52', 'categories': [{'measurements': [{'value': '-0.018', 'spread': '0.0077', 'groupId': 'OG000'}, {'value': '-0.008', 'spread': '0.0077', 'groupId': 'OG001'}]}]}, {'title': 'EQ VAS Score at Week 52', 'categories': [{'measurements': [{'value': '1.56', 'spread': '0.733', 'groupId': 'OG000'}, {'value': '1.91', 'spread': '0.739', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.128', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.015', 'ciLowerLimit': '-0.034', 'ciUpperLimit': '0.004', 'groupDescription': 'EQ-5D-5L Health State Index Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.196', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.11', 'ciLowerLimit': '-2.80', 'ciUpperLimit': '0.58', 'groupDescription': 'EQ VAS Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.285', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.010', 'ciLowerLimit': '-0.029', 'ciUpperLimit': '0.008', 'groupDescription': 'EQ-5D-5L Health State Index Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.701', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-2.15', 'ciUpperLimit': '1.44', 'groupDescription': 'EQ VAS Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26, Week 52', 'description': "The EQ-5D-5L is a multidimensional, health-related, quality-of-life instrument. It includes 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that are assessed at 5 levels of response (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). The scores in the 5 dimensions were summarized into a health state index score. A single health-state index value was derived, which ranges from less than 0 (health state equivalent to death, negative values are valued as worse than death) to 1 (perfect health). The EQ VAS rates the participants' perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). This score provides a composite picture of the respondent's health status.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.Participants who discontinued the study drug due to inadvertent enrollment were excluded.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': '\\- Participants received 500 units per milliliter (U/mL) of insulin efsitora alfa administered subcutaneously (SC) once weekly (QW) over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'FG001', 'title': '100 U/mL - Insulin Degludec', 'description': '\\- Participants received 100 U/mL insulin degludec administered SC once daily (QD) over a 52-week treatment period, followed by a 5-week safety follow-up period.'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '466'}, {'groupId': 'FG001', 'numSubjects': '462'}]}, {'type': 'Participants Using GLP-1 Receptor Agonists', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}, {'groupId': 'FG001', 'numSubjects': '232'}]}, {'type': 'Participants Not Using GLP-1 Receptor Agonists', 'achievements': [{'groupId': 'FG000', 'numSubjects': '234'}, {'groupId': 'FG001', 'numSubjects': '230'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '466'}, {'groupId': 'FG001', 'numSubjects': '462'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '441'}, {'groupId': 'FG001', 'numSubjects': '439'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Assigned treatment by mistake', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}, {'title': 'Follow-Up Period', 'milestones': [{'type': 'STARTED', 'comment': 'Per the statistical analysis plan, participants who completed the study treatment period were required to complete a safety follow-up period and participants who discontinued the study treatment prematurely were encouraged to remain in the study for safety monitoring.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '445'}, {'groupId': 'FG001', 'numSubjects': '444'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '441'}, {'groupId': 'FG001', 'numSubjects': '439'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Participants continued their protocol-specified stable therapy with 1 to 3 non-insulin antihyperglycemic medications, including glucagon-like peptide-1 receptor agonists (GLP-1 RA), as well as non-GLP-1 receptor agonists such as dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter 2 (SGLT2) inhibitors, biguanides (e.g., metformin), alpha-glucosidase inhibitors, sulfonylureas (SUs), or thiazolidinediones throughout the study, at the discretion of the investigator.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'BG000'}, {'value': '462', 'groupId': 'BG001'}, {'value': '928', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '500 U/mL - Insulin Efsitora Alfa', 'description': 'Participants received 500 U/mL insulin efsitora alfa administered SC QW over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'BG001', 'title': '100 U/mL - Insulin Degludec', 'description': 'Participants received 100 U/mL insulin degludec administered SC QD over a 52-week treatment period, followed by a 5-week safety follow-up period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '57.3', 'spread': '11', 'groupId': 'BG001'}, {'value': '57.4', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '382', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '281', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '546', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '345', 'groupId': 'BG000'}, {'value': '335', 'groupId': 'BG001'}, {'value': '680', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '235', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '468', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'China', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}, {'title': 'South Korea', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'HemoglobinA1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.21', 'spread': '0.96', 'groupId': 'BG000'}, {'value': '8.23', 'spread': '0.96', 'groupId': 'BG001'}, {'value': '8.22', 'spread': '0.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-13', 'size': 2715389, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-06T07:39', 'hasProtocol': True}, {'date': '2024-04-22', 'size': 864122, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-06T08:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 928}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2022-05-02', 'resultsFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2022-05-02', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-05', 'studyFirstPostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in HbA1c at Week 52 [Noninferiority Analysis]', 'timeFrame': 'Baseline, Week 52', 'description': '* HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.\n* Least Squares (LS) mean was determined using Analysis of Covariance (ANCOVA) model with Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HbA1c at Week 52 in Participants Using GLP-1 Receptor Agonists [Noninferiority Analysis]', 'timeFrame': 'Baseline, Week 52', 'description': '* HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.\n* LS mean was determined using ANCOVA model with Baseline + Country + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach.'}, {'measure': 'Change From Baseline in HbA1c at Week 52 in Participants Not Using GLP-1 Receptor Agonists [Noninferiority Analysis]', 'timeFrame': 'Baseline, Week 52', 'description': '* HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.\n* LS mean was determined using ANCOVA model with Baseline + Country + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach.'}, {'measure': 'Change From Baseline in HbA1c at Week 52 [Superiority Analysis]', 'timeFrame': 'Baseline, Week 52', 'description': '* HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.\n* LS mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputations approach.'}, {'measure': 'Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] - Week 48 to Week 52', 'timeFrame': 'Week 48 to Week 52', 'description': '* Percentage of time spent within the blood glucose range of 70 to 180 milligrams per deciliter (mg/dL) \\[3.9 to 10.0 millimoles per liter (mmol/L)\\], as measured during the continuous glucose monitoring (CGM) session over a 24-hour period, from Week 48 to Week 52.\n* LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed using multiple imputation under the assumption of missing at random, while missing data at Week 48-52 were imputed using a return-to-baseline multiple imputation approach.'}, {'measure': 'Change From Baseline in HbA1c at Week 26 [Superiority Analysis]', 'timeFrame': 'Baseline, Week 26', 'description': '* HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.\n* LS mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach.'}, {'measure': 'Percentage of Time in the Blood Glucose Range Between 70 and 180 mg/dL [3.9 and 10.0 mmol/L] - Week 22 to Week 26', 'timeFrame': 'Week 22 to Week 26', 'description': '* Percentage of time spent within the blood glucose range of 70 to 180 mg/dL (3.9 to 10.0 mmol/L), as measured during the CGM session over a 24-hour period, from Week 22 to Week 26.\n* LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at baseline were imputed using multiple imputation under the assumption of missing at random, while missing data at Week 22-26 were imputed using a return-to-baseline multiple imputation approach.'}, {'measure': 'Change From Baseline in Fasting Blood Glucose (FBG)', 'timeFrame': 'Baseline, Week 26, Week 52', 'description': 'Change from baseline in fasting blood glucose measured by self-monitoring blood glucose (SMBG).'}, {'measure': 'Glucose Variability', 'timeFrame': 'Week 22 to Week 26 and Week 48 to Week 52', 'description': '* Glucose variability measured as coefficient of variation (CV) for blood glucose during the CGM session over a 24-hour period, between Week 22 to Week 26 and Week 48 to Week 52 was reported.\n* LS mean was determined using Mixed Model Repeated Measures (MMRM) model with Baseline + Country +HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Basal Insulin Dose', 'timeFrame': 'Week 26 and Week 52', 'description': "* The insulin dose was calculated based on the participant's entry of daily or weekly insulin doses in an electronic diary. The average weekly basal insulin dose at Week 26 and Week 52 was reported.\n* LS mean was determined using MMRM model with Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables."}, {'measure': 'Hypoglycemia Event Rate', 'timeFrame': 'Baseline up to Week 52', 'description': '* A hypoglycemic event with blood glucose (BG) levels of less than (\\<) 54 mg/dL (3.0 mmol/L) \\[Level 2\\] or Severe Hypoglycemia \\[Level 3\\] was reported. A severe hypoglycemic event was characterized by altered mental or physical status, requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia.\n* Group mean was reported and determined by Negative binomial model using Number of episodes = HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.'}, {'measure': 'Nocturnal Hypoglycemia Event Rate', 'timeFrame': 'Baseline up to Week 52', 'description': '* The event rate of participant-reported clinically significant nocturnal hypoglycemia (defined as blood glucose level \\<54 mg/dL (3.0 mmol/L) or severe hypoglycemia and occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment phase up to week 52.\n* Group mean was reported and determined by Negative binomial model using Number of episodes = HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.'}, {'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Baseline, Week 26, Week 52', 'description': 'Change from baseline in body weight was reported. LS mean was determined by MMRM model with Baseline + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Percentage of Time in Hypoglycemia Range With Blood Glucose <70 mg/dL (3.9 mmol/L)', 'timeFrame': 'Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52', 'description': '* Percentage of time spent in the hypoglycemia range with blood glucose \\<70 mg/dL (3.9 mmol/L), as measured during the CGM session over a 24-hour period from Week 8 to Week 12, Week 22 to Week 26, and Week 48 to Week 52 was reported.\n* LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Percentage of Time in Hypoglycemia Range With Blood Glucose <54 mg/dL (3.0 mmol/L)', 'timeFrame': 'Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52', 'description': '* Percentage of time spent in the hypoglycemia range with blood glucose \\< 54 mg/dL (3.0 mmol/L), as measured during the CGM session over a 24-hour period from Week 8 to Week 12, Week 22 to Week 26, and Week 48 to Week 52, was reported.\n* LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Percentage of Time in Hyperglycemia Range With Blood Glucose >180 mg/dL (10.0 mmol/L)', 'timeFrame': 'Week 8 to Week 12, Week 22 to Week 26 and Week 48 to Week 52', 'description': '* Percentage of time spent in the hyperglycemia range with blood glucose greater than (\\>) 180 mg/dL (10.0 mmol/L), as measured during the CGM session over a 24-hour period from Week 8 to Week 12, Week 22 to Week 26, and Week 48 to Week 52 was reported.\n* LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Change From Baseline in Treatment-Related Impact Measures for Diabetes (TRIM-D) -Total Score at Week 26 and Week 52', 'timeFrame': 'Baseline, Week 26, Week 52', 'description': "* The TRIM-D is a participant-reported measure designed to assess the impact of diabetes treatment on individuals' functioning and well-being across different diabetes treatments. The questionnaire includes 28 items grouped into 5 sub-domains: treatment burden, daily life, diabetes management, compliance, and psychological health. Each item is assessed on a 5-point scale, with higher scores indicating better health status. All items were summed to obtain a total raw score, which was transformed to a scale of 0 to 100 to obtain a total score. The total score range is 0-100, with a higher total score indicating better overall health and well-being, while a lower total score indicates worse health or well-being.\n* LS mean was determined using MMRM model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables."}, {'measure': 'Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores at Week 26 and Week 52', 'timeFrame': 'Baseline, Week 26, Week 52', 'description': 'The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Each domain is scored individually, and information from these 8 domains is further aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.'}, {'measure': 'Change From Baseline in EuroQuality of Life (EuroQol) - 5 Dimensions-5 Levels (EQ-5D-5L) Health State Index and EQ Visual Analog Scale (VAS) Scores at Week 26 and Week 52', 'timeFrame': 'Baseline, Week 26, Week 52', 'description': "The EQ-5D-5L is a multidimensional, health-related, quality-of-life instrument. It includes 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that are assessed at 5 levels of response (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). The scores in the 5 dimensions were summarized into a health state index score. A single health-state index value was derived, which ranges from less than 0 (health state equivalent to death, negative values are valued as worse than death) to 1 (perfect health). The EQ VAS rates the participants' perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). This score provides a composite picture of the respondent's health status."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '39254740', 'type': 'DERIVED', 'citation': 'Wysham C, Bajaj HS, Del Prato S, Franco DR, Kiyosue A, Dahl D, Zhou C, Carr MC, Case M, Firmino Goncalves L; QWINT-2 Investigators. Insulin Efsitora versus Degludec in Type 2 Diabetes without Previous Insulin Treatment. N Engl J Med. 2024 Dec 12;391(23):2201-2211. doi: 10.1056/NEJMoa2403953. Epub 2024 Sep 10.'}], 'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/find/completed?trialname=%20I8H-MC-BDCX&externalRequestID=68cbce79-fbf1-46c5-852a-338ca6e2be85', 'label': 'A Study of LY3209590 Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-2)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect and safety of insulin efsitora alfa (LY3209590) compared to degludec in adult participants with type 2 diabetes who are starting basal insulin for the first time. The study consists of a 1-week screening period, a 2-week lead-in period, a 52-week treatment period, and a 5-week safety follow-up period. The study will last up to 60 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have diagnosis of Type 2 diabetes (T2D) according to the World Health Organization Criteria\n* Have an Hemoglobin A1c (HbA1c) of 7.0 percent (%) - 10.5% inclusive, at screening\n* Are on a stable treatment with 1 to 3 antihyperglycemic medication for at least 3 months prior to screening and willing to continue the stable treatment for the duration of the study\n* These antihyperglycemic medications are accepted in the study\n\n * dipeptidyl peptidase-4 (DPP-4) inhibitors\n * sodium-glucose cotransporter 2 (SGLT2) inhibitors\n * biguanides, such as metformin\n * alpha-glucosidase inhibitors\n * glucagon-like peptide-1 (GLP-1) receptor agonists, oral or injectable\n * Sulfonylureas, or\n * Thiazolidinediones.\n* Are insulin naïve.\n\nExceptions:\n\n* short-term insulin treatment for a maximum of 14 days, prior to screening, and prior insulin treatment for gestational diabetes\n\n * Have a body mass index of less than or equal to (≤) 45 kilogram/square meter (kg/m²).\n\nExclusion Criteria:\n\n* Have a diagnosis of Type 1 diabetes (T1D), latent autoimmune diabetes, or a specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug-induced or chemical-induced diabetes.\n* Have a history of greater than (\\>) 1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening. Have had severe hypoglycemia episodes within 6 months prior to screening. Have a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate.\n* Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.\n* Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening\n\n * Acute myocardial infarction\n * Cerebrovascular accident (stroke), or\n * Coronary bypass surgery.\n * Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening\n * Have had significant weight gain or loss within 3 months prior to screening, for example, greater than or equal to (≥) 5%.'}, 'identificationModule': {'nctId': 'NCT05362058', 'acronym': 'QWINT-2', 'briefTitle': 'A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Degludec in Insulin Naïve Adults With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '18262'}, 'secondaryIdInfos': [{'id': 'I8H-MC-BDCX', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2021-005891-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '500 U/mL - Insulin Efsitora Alfa', 'description': '* Participants received 500 units per milliliter (U/mL) of insulin efsitora alfa administered subcutaneously (SC) once weekly (QW) over a 52-week treatment period, followed by a 5-week safety follow-up period.\n* Participants continued their protocol-specified stable therapy with non-insulin antihyperglycemic medications throughout the study, at the discretion of the investigator.', 'interventionNames': ['Drug: Insulin Efsitora Alfa']}, {'type': 'ACTIVE_COMPARATOR', 'label': '100 U/mL - Insulin Degludec', 'description': '* Participants received 100 U/mL insulin degludec administered SC once daily (QD) over a 52-week treatment period, followed by a 5-week safety follow-up period.\n* Participants continued their protocol-specified stable therapy with non-insulin antihyperglycemic medications throughout the study, at the discretion of the investigator.', 'interventionNames': ['Drug: Insulin Degludec']}], 'interventions': [{'name': 'Insulin Efsitora Alfa', 'type': 'DRUG', 'otherNames': ['LY3209590 and Basal Insulin-FC'], 'description': 'Administered SC', 'armGroupLabels': ['500 U/mL - Insulin Efsitora Alfa']}, {'name': 'Insulin Degludec', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['100 U/mL - Insulin Degludec']}]}, 'contactsLocationsModule': 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