Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT05662332
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2022-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '08004595979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Week 57', 'description': 'All randomized participants who received atleast one dose of study drug. Participants were analyzed according to the treatment they were assigned. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Efsitora', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.', 'otherNumAtRisk': 397, 'deathsNumAtRisk': 397, 'otherNumAffected': 104, 'seriousNumAtRisk': 397, 'deathsNumAffected': 3, 'seriousNumAffected': 26}, {'id': 'EG001', 'title': 'Glargine', 'description': 'Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.', 'otherNumAtRisk': 398, 'deathsNumAtRisk': 398, 'otherNumAffected': 121, 'seriousNumAtRisk': 398, 'deathsNumAffected': 3, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 30, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 26, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 27, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Drug titration error', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 53, 'numAffected': 39}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dermatofibrosarcoma protuberans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hepatic cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cerebellar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abnormal uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Adnexa uteri mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 194, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Breast hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Prostatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 195, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority Analysis]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efsitora', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.19', 'spread': '0.0546', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '0.0545', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority margin (NIM) was 0.4%'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over the last 2-3 months. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation 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, excluding participants discontinuing the study treatment due to inadvertent enrollment. All measurements were included regardless of the use of study treatment or rescue medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c [Superiority]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efsitora', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.19', 'spread': '0.0546', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '0.0545', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.684', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation 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, excluding participants discontinuing the study treatment due to inadvertent enrollment. All measurements were included regardless of the use of study treatment or rescue medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efsitora', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.'}], 'classes': [{'categories': [{'measurements': [{'value': '-46.76', 'spread': '2.0797', 'groupId': 'OG000'}, {'value': '-50.92', 'spread': '2.0595', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.155', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.16', 'ciLowerLimit': '-1.58', 'ciUpperLimit': '9.90', 'groupDescription': 'Week 52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Change from baseline in fasting blood glucose measured by self-monitoring blood glucose (SMBG). LS mean was determined using ANCOVA model with Variable = Baseline + Country + GLP-1 RA Use at Baseline + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares).', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', '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': 'Basal Insulin Dose at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efsitora', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.'}], 'classes': [{'categories': [{'measurements': [{'value': '289.1', 'spread': '6.81', 'groupId': 'OG000'}, {'value': '332.8', 'spread': '6.68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Change difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-43.7', 'ciLowerLimit': '-62.4', 'ciUpperLimit': '-25.0', 'groupDescription': 'Week 52', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 52', 'description': 'The insulin dose was recorded daily or weekly in an electronic diary. The average weekly basal insulin dose at Week 52 was reported. LS mean was determined using MMRM model with Baseline + Hemoglobin A1c Stratum at Baseline + Country + GLP-1 RA use at Randomization + 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 evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Rate Per Year of Hypoglycemia Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efsitora', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'spread': '0.062', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '0.152', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '0.39', 'ciUpperLimit': '0.84', 'statisticalMethod': 'Negative binomial model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 52', 'description': 'Rate of Composite Level 2 and 3 Hypoglycemia Events were reported. Hypoglycemia with glucose \\<54 mg/dL (Level 2) or Severe Hypoglycemia confirmed by the investigator to be an event that required assistance for treatment (Level 3) was reported. A severe hypoglycemic event is characterized by altered mental or physical status requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia.\n\nGroup mean was reported and determined by Negative binomial model using Number of episodes = Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.', 'unitOfMeasure': 'Events per year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Hypoglycemia Events (Incidence)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efsitora', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.94', 'groupId': 'OG000'}, {'value': '29.90', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to the study drug. Incidence of Composite Level 2 and 3 Hypoglycemia Events was reported. Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia with glucose \\<54 mg/dL (Level 2) or severe hypoglycemia confirmed by the investigator to be an event that required assistance for treatment (Level 3). A severe hypoglycemic event is characterized by altered mental or physical status requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Rate Per Year of Nocturnal Hypoglycemia Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efsitora', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.013', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.021', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.155', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.28', 'ciUpperLimit': '1.23', 'statisticalMethod': 'Negative binomial model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 52', 'description': 'The event rate of participant-reported clinically significant glucose \\<54 mg/dL (3.0 mmol/L) or severe nocturnal hypoglycemia that occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment period up to week 52. Group mean is reported here. Group mean is determined by Negative Binomial Model using Number of episodes = .Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.', 'unitOfMeasure': 'Events per year', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of the study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Nocturnal Hypoglycemia Events (Incidence)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efsitora', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.53', 'groupId': 'OG000'}, {'value': '5.03', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Incidence of nocturnal hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to the study drug. Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. The event rate of participant-reported clinically significant glucose \\<54 mg/dL (3.0 mmol/L) or severe nocturnal hypoglycemia that occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment period up to week 52..', 'unitOfMeasure': 'percentage of participants', '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': '357', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efsitora', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.86', 'spread': '0.190', 'groupId': 'OG000'}, {'value': '3.29', 'spread': '0.189', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.033', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '0.047', 'ciUpperLimit': '1.10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Change from baseline in body weight was reported. LS mean was determined using ANCOVA model with Variable = Baseline + Country + GLP-1 RA Use at Baseline + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares).', 'unitOfMeasure': 'Kilogram (kg)', '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': 'Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efsitora', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'spread': '0.608', 'groupId': 'OG000'}, {'value': '13.87', 'spread': '0.607', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.071', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.56', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '3.25', 'groupDescription': 'Week 52', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "The TRIM-D is a self-administered instrument, which assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments. The TRIM-D consists of 28 items, each assessed on a 5-point scale. The TRIM-D questionnaire consists of 5 sub-domains.\n\nTreatment Burden (6 items) Daily Life (5 items) Diabetes Management (5 items), Compliance (4 items), and Psychological Health (8 items), where each question is scored on a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D individual sub-domain scores and total scores are later transformed to a 0-100 scale for analysis. LS mean change in scores from baseline to 52 weeks for total score are presented here.\n\nLS mean was determined using MMRM model with BASELINE + Hemoglobin A1c Stratum at Baseline + Country + GLP-1 RA. Use at Randomization + 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 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': 'Change From Baseline in Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQ-c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efsitora', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.'}], 'classes': [{'title': 'Perceived frequency of hypoglycemia score', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.89', 'groupId': 'OG001'}]}]}, {'title': 'Perceived frequency of hyperglycemia score', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.80', 'groupId': 'OG001'}]}]}, {'title': 'Treatment satisfaction score', 'categories': [{'measurements': [{'value': '15.1', 'spread': '4.57', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '4.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The DTSQ-c is a validated, patient-reported questionnaire designed to assess perceived changes in satisfaction with diabetes treatment over time. It is especially useful in clinical trials comparing a new treatment to a previous one. The DTSQ-c includes 8 items, each scored on a 7-point Likert scale ranging from -3 (Much less satisfied) to +3 (Much more satisfied). A score of 0 indicates no change in perception.\n\nThis outcome reports three domains: (1) Perceived frequency of hypoglycaemia - lower scores reflect fewer perceived episodes; (2) Perceived frequency of hyperglycaemia - lower scores reflect fewer perceived episodes; (3) Treatment satisfaction -Aggregated score from the remaining 6 items assessing satisfaction with treatment, convenience, flexibility, understanding, and willingness to continue. A higher scores indicating greater improvement in satisfaction. Total score range: -18 to +18.', 'unitOfMeasure': 'Score on a scale', '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': 'Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Efsitora Alfa', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.'}], 'classes': [{'title': 'SIMQF - How Simple or Complex Medication: Very Complex', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'SIMQF - How Simple or Complex Medication: Complex', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'SIMQF - How Simple or Complex Medication: A Little Complex', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}, {'value': '6.6', 'groupId': 'OG001'}]}]}, {'title': 'SIMQF - How Simple or Complex Medication: Simple', 'categories': [{'measurements': [{'value': '37.2', 'groupId': 'OG000'}, {'value': '41.2', 'groupId': 'OG001'}]}]}, {'title': 'SIMQF - How Simple or Complex Medication: Very Simple', 'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000'}, {'value': '48.7', 'groupId': 'OG001'}]}]}, {'title': 'SIMQF - Overall How to Manage Diabetes: Very Complex', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'SIMQF - Overall How to Manage Diabetes: Complex', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'SIMQF - Overall How to Manage Diabetes : A Little Complex', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '15.5', 'groupId': 'OG001'}]}]}, {'title': 'SIMQF - Overall How to Manage Diabetes: Simple', 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000'}, {'value': '40.3', 'groupId': 'OG001'}]}]}, {'title': 'SIMQF - Overall How to Manage Diabetes: Very Simple', 'categories': [{'measurements': [{'value': '36.3', 'groupId': 'OG000'}, {'value': '36.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'The SIM-Q is a brief 10-item measure developed to assess the simplicity and complexity of treatment for T2D. This version of the instrument assesses the simplicity and complexity of a single medication. Only the last 2 questions/items of the SIM-Q were completed by the study participants:\n\n1. "How simple or complex is your medication treatment for diabetes?"\n2. "Overall, how simple or complex is it to manage your diabetes, including medication, checking your blood glucose levels, diet, and any other aspects of diabetes treatment?" Participants were asked to provide responses to the study intervention at Week 52. Each item is scored on a 5-point scale ranging from "Very complex" to "Very simple." Higher scores indicate a more favorable (simpler) treatment experience.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome. Participants who discontinued the study drug due to inadvertent enrollment were excluded.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efsitora', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.4', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '89.6', 'spread': '0.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.072', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '3.8', 'groupDescription': 'Week 52', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "DID-EQ is a validated, self-administered, 10-item PRO instrument designed to assess participants' perceptions of diabetes injection delivery systems.This outcome measure reports only the Device Characteristics Subscale, which includes Items 1 through 7. These items evaluate specific features of injection devices such as:\n\n* Ease of preparation\n* Comfort during injection\n* Portability\n* Discreetness\n* Confidence in dose delivery\n* Ease of learning to use\n* Satisfaction with device features\n\nEach item is rated on a 4-point Likert scale: Strongly Disagree, Disagree, Agree, Strongly Agree. Responses are transformed to a 0-100 scale, where 0 represents most negative perception and 100 represents the most positive perception.Higher scores indicate more favorable perceptions of the injection device.\n\nLS Mean determined using ANCOVA model with Country + GLP-1 RA Use at Randomization + HbA1c Stratum at Baseline + 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 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': 'Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efsitora', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.'}, {'id': 'OG001', 'title': 'Glargine', 'description': 'Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.'}], 'classes': [{'title': 'Satisfied with the Injection Device (Strongly disagree)', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied with the Injection Device (Disagree)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied with the Injection Device (Agree)', 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}, {'value': '19.1', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied with the Injection Device (Strongly Agree)', 'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000'}, {'value': '79.4', 'groupId': 'OG001'}]}]}, {'title': 'Easy to Use the Injection Device (Strongly disagree)', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Easy to Use the Injection Device (Disagree)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Easy to Use the Injection Device (Agree)', 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}]}]}, {'title': 'Easy to Use the Injection Device (Strongly Agree)', 'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG000'}, {'value': '81.7', 'groupId': 'OG001'}]}]}, {'title': 'Convenient to Use the Injection Device (Strongly disagree)', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Convenient to Use the Injection Device (Disagree)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Convenient to Use the Injection Device (Agree)', 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000'}, {'value': '20.3', 'groupId': 'OG001'}]}]}, {'title': 'Convenient to Use the Injection Device (Strongly agree)', 'categories': [{'measurements': [{'value': '82.3', 'groupId': 'OG000'}, {'value': '78.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "The DID-EQ is a validated, self-administered, 10-item PRO instrument designed to assess participants' perceptions of diabetes injection delivery systems.\n\nThis outcome measure specifically reports the summary of DID-EQ scores for the 3 global items:\n\n* Item 8: Overall satisfaction with the injection device\n* Item 9: Ease of use of the injection device\n* Item 10: Convenience of the injection device\n\nEach item is rated on a 4-point Likert scale:\n\n* Strongly Disagree\n* Disagree\n* Agree\n* Strongly Agree\n\nResponses are transformed to a 0-100 scale, where:\n\n* 0 = Most negative perception\n* 100 = Most positive perception\n\nHigher scores indicate more favorable perceptions of the injection device's global characteristics.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome. Participants who discontinued the study drug due to inadvertent enrollment were excluded.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Efsitora Alfa', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.'}, {'id': 'FG001', 'title': 'Insulin Glargine', 'description': 'Participants received insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '397'}, {'groupId': 'FG001', 'numSubjects': '398'}]}, {'type': 'Received at Least One Dose of the Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '397'}, {'groupId': 'FG001', 'numSubjects': '398'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '362'}, {'groupId': 'FG001', 'numSubjects': '361'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Assigned Treatment by Mistake', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Due to Bariatric surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subject Moving out of State', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject Missed the Schedule', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'The Patient Moved to Another City', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'BG000'}, {'value': '398', 'groupId': 'BG001'}, {'value': '795', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Efsitora', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.'}, {'id': 'BG001', 'title': 'Glargine', 'description': 'Participants received Insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'BG000'}, {'value': '398', 'groupId': 'BG001'}, {'value': '795', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56.40', 'spread': '10.02', 'groupId': 'BG000'}, {'value': '56.20', 'spread': '9.67', 'groupId': 'BG001'}, {'value': '56.30', 'spread': '9.84', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'BG000'}, {'value': '398', 'groupId': 'BG001'}, {'value': '795', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'BG000'}, {'value': '398', 'groupId': 'BG001'}, {'value': '795', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '338', 'groupId': 'BG000'}, {'value': '336', 'groupId': 'BG001'}, {'value': '674', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'BG000'}, {'value': '398', 'groupId': 'BG001'}, {'value': '795', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '270', 'groupId': 'BG000'}, {'value': '272', 'groupId': 'BG001'}, {'value': '542', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'BG000'}, {'value': '398', 'groupId': 'BG001'}, {'value': '795', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '341', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'BG000'}, {'value': '398', 'groupId': 'BG001'}, {'value': '795', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'BG000'}, {'value': '398', 'groupId': 'BG001'}, {'value': '795', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HemoglobinA1c (HbA1c)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'BG000'}, {'value': '391', 'groupId': 'BG001'}, {'value': '783', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.20', 'spread': '0.91', 'groupId': 'BG000'}, {'value': '8.28', 'spread': '1.06', 'groupId': 'BG001'}, {'value': '8.24', 'spread': '0.99', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over the last 2-3 months.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All randomized participants who received at least one dose of the study drug and had HbA1c measurement at baseline.'}], 'populationDescription': 'All randomized participants who received at least one dose of the study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-31', 'size': 1310368, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-14T12:58', 'hasProtocol': True}, {'date': '2024-07-26', 'size': 803543, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-14T12:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Sponsor will be blinded throughout the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 795}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-19', 'studyFirstSubmitDate': '2022-12-15', 'resultsFirstSubmitDate': '2025-07-19', 'studyFirstSubmitQcDate': '2022-12-21', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-19', 'studyFirstPostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority Analysis]', 'timeFrame': 'Baseline, Week 52', 'description': 'HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over the last 2-3 months. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation approach.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HbA1c [Superiority]', 'timeFrame': 'Baseline, Week 52', 'description': 'HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + GLP-1 RA Use at Randomization Flag + Treatment (Type III sum of squares) as variables. Missing data at Week 52 were imputed by return-to-baseline multiple imputation approach.'}, {'measure': 'Change From Baseline in Fasting Glucose', 'timeFrame': 'Baseline, Week 52', 'description': 'Change from baseline in fasting blood glucose measured by self-monitoring blood glucose (SMBG). LS mean was determined using ANCOVA model with Variable = Baseline + Country + GLP-1 RA Use at Baseline + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares).'}, {'measure': 'Basal Insulin Dose at Week 52', 'timeFrame': 'Week 52', 'description': 'The insulin dose was recorded daily or weekly in an electronic diary. The average weekly basal insulin dose at Week 52 was reported. LS mean was determined using MMRM model with Baseline + Hemoglobin A1c Stratum at Baseline + Country + GLP-1 RA use at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables.'}, {'measure': 'Rate Per Year of Hypoglycemia Events', 'timeFrame': 'Baseline up to Week 52', 'description': 'Rate of Composite Level 2 and 3 Hypoglycemia Events were reported. Hypoglycemia with glucose \\<54 mg/dL (Level 2) or Severe Hypoglycemia confirmed by the investigator to be an event that required assistance for treatment (Level 3) was reported. A severe hypoglycemic event is characterized by altered mental or physical status requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia.\n\nGroup mean was reported and determined by Negative binomial model using Number of episodes = Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.'}, {'measure': 'Percentage of Participants With Hypoglycemia Events (Incidence)', 'timeFrame': 'Week 52', 'description': 'Incidence of hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to the study drug. Incidence of Composite Level 2 and 3 Hypoglycemia Events was reported. Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia with glucose \\<54 mg/dL (Level 2) or severe hypoglycemia confirmed by the investigator to be an event that required assistance for treatment (Level 3). A severe hypoglycemic event is characterized by altered mental or physical status requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions for the treatment of hypoglycemia.'}, {'measure': 'Rate Per Year of Nocturnal Hypoglycemia Events', 'timeFrame': 'Baseline up to Week 52', 'description': 'The event rate of participant-reported clinically significant glucose \\<54 mg/dL (3.0 mmol/L) or severe nocturnal hypoglycemia that occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment period up to week 52. Group mean is reported here. Group mean is determined by Negative Binomial Model using Number of episodes = .Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.'}, {'measure': 'Percentage of Participants With Nocturnal Hypoglycemia Events (Incidence)', 'timeFrame': 'Week 52', 'description': 'Incidence of nocturnal hypoglycemic episodes is defined as 100 multiplied by the number of participants experiencing a hypoglycemic episode divided by the number of participants exposed to the study drug. Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. The event rate of participant-reported clinically significant glucose \\<54 mg/dL (3.0 mmol/L) or severe nocturnal hypoglycemia that occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment period up to week 52..'}, {'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Baseline, Week 52', 'description': 'Change from baseline in body weight was reported. LS mean was determined using ANCOVA model with Variable = Baseline + Country + GLP-1 RA Use at Baseline + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares).'}, {'measure': 'Change From Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) Total Score', 'timeFrame': 'Baseline, Week 52', 'description': "The TRIM-D is a self-administered instrument, which assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments. The TRIM-D consists of 28 items, each assessed on a 5-point scale. The TRIM-D questionnaire consists of 5 sub-domains.\n\nTreatment Burden (6 items) Daily Life (5 items) Diabetes Management (5 items), Compliance (4 items), and Psychological Health (8 items), where each question is scored on a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D individual sub-domain scores and total scores are later transformed to a 0-100 scale for analysis. LS mean change in scores from baseline to 52 weeks for total score are presented here.\n\nLS mean was determined using MMRM model with BASELINE + Hemoglobin A1c Stratum at Baseline + Country + GLP-1 RA. Use at Randomization + Treatment + Time + Treatment\\*Time(Type III sum of squares) as variables."}, {'measure': 'Change From Baseline in Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQ-c)', 'timeFrame': 'Baseline, Week 52', 'description': 'The DTSQ-c is a validated, patient-reported questionnaire designed to assess perceived changes in satisfaction with diabetes treatment over time. It is especially useful in clinical trials comparing a new treatment to a previous one. The DTSQ-c includes 8 items, each scored on a 7-point Likert scale ranging from -3 (Much less satisfied) to +3 (Much more satisfied). A score of 0 indicates no change in perception.\n\nThis outcome reports three domains: (1) Perceived frequency of hypoglycaemia - lower scores reflect fewer perceived episodes; (2) Perceived frequency of hyperglycaemia - lower scores reflect fewer perceived episodes; (3) Treatment satisfaction -Aggregated score from the remaining 6 items assessing satisfaction with treatment, convenience, flexibility, understanding, and willingness to continue. A higher scores indicating greater improvement in satisfaction. Total score range: -18 to +18.'}, {'measure': 'Percentage of Participants Reporting Treatment Experience Using the Simplicity of Diabetes Treatment Questionnaire (SIM-Q) Single Medication Status Version', 'timeFrame': 'Week 52', 'description': 'The SIM-Q is a brief 10-item measure developed to assess the simplicity and complexity of treatment for T2D. This version of the instrument assesses the simplicity and complexity of a single medication. Only the last 2 questions/items of the SIM-Q were completed by the study participants:\n\n1. "How simple or complex is your medication treatment for diabetes?"\n2. "Overall, how simple or complex is it to manage your diabetes, including medication, checking your blood glucose levels, diet, and any other aspects of diabetes treatment?" Participants were asked to provide responses to the study intervention at Week 52. Each item is scored on a 5-point scale ranging from "Very complex" to "Very simple." Higher scores indicate a more favorable (simpler) treatment experience.'}, {'measure': 'Change From Baseline in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics', 'timeFrame': 'Baseline, Week 52', 'description': "DID-EQ is a validated, self-administered, 10-item PRO instrument designed to assess participants' perceptions of diabetes injection delivery systems.This outcome measure reports only the Device Characteristics Subscale, which includes Items 1 through 7. These items evaluate specific features of injection devices such as:\n\n* Ease of preparation\n* Comfort during injection\n* Portability\n* Discreetness\n* Confidence in dose delivery\n* Ease of learning to use\n* Satisfaction with device features\n\nEach item is rated on a 4-point Likert scale: Strongly Disagree, Disagree, Agree, Strongly Agree. Responses are transformed to a 0-100 scale, where 0 represents most negative perception and 100 represents the most positive perception.Higher scores indicate more favorable perceptions of the injection device.\n\nLS Mean determined using ANCOVA model with Country + GLP-1 RA Use at Randomization + HbA1c Stratum at Baseline + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables."}, {'measure': 'Percentage of Participants in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) (3-Global Items)', 'timeFrame': 'Week 52', 'description': "The DID-EQ is a validated, self-administered, 10-item PRO instrument designed to assess participants' perceptions of diabetes injection delivery systems.\n\nThis outcome measure specifically reports the summary of DID-EQ scores for the 3 global items:\n\n* Item 8: Overall satisfaction with the injection device\n* Item 9: Ease of use of the injection device\n* Item 10: Convenience of the injection device\n\nEach item is rated on a 4-point Likert scale:\n\n* Strongly Disagree\n* Disagree\n* Agree\n* Strongly Agree\n\nResponses are transformed to a 0-100 scale, where:\n\n* 0 = Most negative perception\n* 100 = Most positive perception\n\nHigher scores indicate more favorable perceptions of the injection device's global characteristics."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'T2D']}, 'referencesModule': {'references': [{'pmid': '40548694', 'type': 'DERIVED', 'citation': 'Rosenstock J, Bailey T, Connery L, Miller E, Desouza C, Wang Q, Leohr J, Knights A, Carr MC, Child CJ; QWINT-1 trial investigators. Weekly Fixed-Dose Insulin Efsitora in Type 2 Diabetes without Previous Insulin Therapy. N Engl J Med. 2025 Jul 24;393(4):325-335. doi: 10.1056/NEJMoa2502796. Epub 2025 Jun 22.'}], 'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/379581', 'label': 'A Study of LY3209590 Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to determine the efficacy and safety of insulin efsitora alfa (LY3209590) administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (T2D) who are starting basal insulin therapy for the first time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of T2D according to the World Health Organization criteria.\n* Have an HbA1c of 7.0% to 10.0%, inclusive, at screening.\n* Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study.\n* Are insulin naive\n\nExceptions:\n\n* short-term insulin treatment for a maximum of 14 days, prior to screening, and\n* prior insulin treatment for gestational diabetes.\n\nExclusion Criteria:\n\n* Have a diagnosis of type 1 diabetes (T1D), latent autoimmune diabetes, or 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 \\>1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.\n* Have had severe hypoglycemia episodes within 6 months prior to screening.\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* 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, ≥5%.'}, 'identificationModule': {'nctId': 'NCT05662332', 'acronym': 'QWINT-1', 'briefTitle': 'A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)', '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 Administered Weekly Using a Fixed Dose Escalation Compared to Insulin Glargine in Insulin-Naïve Adults With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '18261'}, 'secondaryIdInfos': [{'id': 'I8H-MC-BDCW', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin Efsitora Alfa', 'description': 'Participants received Insulin Efsitora Alfa (insulin efsitora; 500 U/ml) administered subcutaneously (SC) once weekly (QW) for 52 weeks, with titration using fixed-doses 100 U, 150 U, 250 U, and 400 U.', 'interventionNames': ['Drug: Insulin Efsitora Alfa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Glargine', 'description': 'Participants received insulin glargine (100 U/ml) administered SC once daily (QD) for 52 weeks with titration by standard sliding-scale dose adjustments.', 'interventionNames': ['Drug: Insulin Glargine']}], 'interventions': [{'name': 'Insulin Efsitora Alfa', 'type': 'DRUG', 'otherNames': ['LY3209590 and Basal Insulin-FC'], 'description': 'Administered SC', 'armGroupLabels': ['Insulin Efsitora Alfa']}, {'name': 'Insulin Glargine', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Insulin Glargine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35242', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cahaba Research', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35660', 'city': 'Sheffield', 'state': 'Alabama', 'country': 'United States', 'facility': 'Syed Research Consultants Llc', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'AMCR Institute', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '90247', 'city': 'Gardena', 'state': 'California', 'country': 'United States', 'facility': 'Velocity Clinical Research, Gardena', 'geoPoint': {'lat': 33.88835, 'lon': -118.30896}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'facility': 'National Research Institute - Huntington Park', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'National Research Institute - Wilshire', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Diabetes Associates Medical Group', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '91978', 'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'facility': 'Encompass Clinical Research', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'zip': '93065', 'city': 'Thousand Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Millennium Clinical Trials', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'University Clinical Investigators, Inc.', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research, Inc.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Chase Medical Research, LLC', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of West Florida, Inc. 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Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}