Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-04-20 @ 12:45 PM
Study NCT ID:
NCT05462756
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2022-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, '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': 'D061268', 'term': 'Insulin Lispro'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-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'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}]}}, '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}}, 'adverseEventsModule': {'timeFrame': 'Baseline Through Safety Follow-Up (Up To 31 Weeks)', 'description': 'All participants who received at least one dose of the study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the cohorts corresponding to the actual regimen received.', 'eventGroups': [{'id': 'EG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.', 'otherNumAtRisk': 365, 'deathsNumAtRisk': 365, 'otherNumAffected': 35, 'seriousNumAtRisk': 365, 'deathsNumAffected': 1, 'seriousNumAffected': 25}, {'id': 'EG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.', 'otherNumAtRisk': 365, 'deathsNumAtRisk': 365, 'otherNumAffected': 40, 'seriousNumAtRisk': 365, 'deathsNumAffected': 1, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Haemoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diabetic foot infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastroenteritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Spinal instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acute psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Postrenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 365, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 365, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.01', 'spread': '0.0463', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '0.0463', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.012', 'ciLowerLimit': '-0.140', 'ciUpperLimit': '0.116', 'groupDescription': 'Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Personal Use of CGM or FGM at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The sample size provided \\>99% statistical power to show noninferiority assuming a 0.4% noninferiority margin (NIM), in insulin efsitora doses compared to insulin glargine, in a 1:1 randomization, a standard deviation (SD) of 1.1%, and a dropout rate of 15%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had at least one post-baseline HbA1c data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HbA1c [Superiority]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.01', 'spread': '0.0463', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '0.0463', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.855', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.012', 'ciLowerLimit': '-0.140', 'ciUpperLimit': '0.116', 'groupDescription': 'Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Personal Use of CGM or FGM at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had at least one post-baseline HbA1c data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving HbA1c <7% Without Nocturnal Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'groupId': 'OG000'}, {'value': '35.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.504', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.52', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'Percentage of participants achieving HbA1c \\<7% without nocturnal hypoglycemia \\[\\<54 milligram/deciliter (mg/dL) 3.0 millimole/Liter (mmol/L)\\] or severe during treatment phase up to week 26. Nocturnal hypoglycemia is a hypoglycemia event, including severe hypoglycemia, that occurs at night and presumably during sleep between midnight and 6:00 am.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Nocturnal Hypoglycemia Event Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.67', 'spread': '0.112', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.151', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.44', 'ciUpperLimit': '1.01', 'estimateComment': 'Relative rate is the ratio of the group means (Insulin Efsitora vs Insulin Glargine).', 'groupDescription': 'Group mean is determined by Negative Binomial Model using Number of episodes = Baseline hypoglycemia rate + Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.', 'statisticalMethod': 'Negative binomial model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Up To Week 26', 'description': 'The event rate of participant-reported clinically significant nocturnal hypoglycemia, (where glucose \\<54 mg/dL (3.0 mmol/L) or severe and occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment phase up to week 26. Group mean is reported here.', 'unitOfMeasure': 'Events per year', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.87', 'spread': '1.876', 'groupId': 'OG000'}, {'value': '-26.58', 'spread': '1.871', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.104', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.29', 'ciLowerLimit': '-9.461', 'ciUpperLimit': '0.886', 'groupDescription': 'LS Mean was determined using ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + 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. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Change from baseline in fasting glucose measured by self-monitoring blood glucose (SMBG).', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time in Glucose Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.39', 'spread': '0.993', 'groupId': 'OG000'}, {'value': '57.05', 'spread': '0.990', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.337', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '-1.404', 'ciUpperLimit': '4.101', 'groupDescription': 'LS Mean was determined using ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + 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 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 22 to Week 26', 'description': 'Percentage of Time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 mmol/L), inclusive measured during the continuous glucose monitoring (CGM) session.', 'unitOfMeasure': 'Percentage of time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time in Hypoglycemia Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.84', 'spread': '0.700', 'groupId': 'OG000'}, {'value': '5.25', 'spread': '0.680', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.104', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '-0.327', 'ciUpperLimit': '3.508', 'groupDescription': 'LS Mean was determined by ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + 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 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 22 to Week 26', 'description': 'Percentage of Time in hypoglycemia range with glucose \\<54 mg/dL (3.0 mmol/L), measured by CGM.', 'unitOfMeasure': 'Percentage of time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time in Hyperglycemia Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '359', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.10', 'spread': '1.024', 'groupId': 'OG000'}, {'value': '41.60', 'spread': '1.024', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.304', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.50', 'ciLowerLimit': '-4.358', 'ciUpperLimit': '1.360', 'groupDescription': 'LS Mean was determined by ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares). Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 22 to Week 26', 'description': 'Percentage of Time in hyperglycemia range with glucose \\>180 mg/dL (10.0 mmol/L), measured by CGM.', 'unitOfMeasure': 'Percentage of time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Glucose Variability Between Weeks 22 to 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.51', 'spread': '0.259', 'groupId': 'OG000'}, {'value': '28.28', 'spread': '0.254', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.523', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.95', 'groupDescription': 'LS Mean was determined by MMRM model with BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables. Unstructured variance-covariance structure was used.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 22 to Week 26', 'description': 'Glucose variability measured as coefficient of variation for glucose within day for 24-hour period between Week 22 and 26 was reported.', 'unitOfMeasure': 'Coefficient of Variation', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Basal Insulin Dose at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.'}], 'classes': [{'categories': [{'measurements': [{'value': '391.59', 'spread': '7.482', 'groupId': 'OG000'}, {'value': '426.62', 'spread': '7.323', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35.04', 'ciLowerLimit': '-55.57', 'ciUpperLimit': '-14.50', 'groupDescription': 'LS Mean was determined by Mixed Model Repeated Measures (MMRM) model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Average weekly basal Insulin Dose at Week 26 was reported.', 'unitOfMeasure': 'Units per week of basal insulin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Bolus Insulin Dose at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.01', 'spread': '1.182', 'groupId': 'OG000'}, {'value': '34.56', 'spread': '1.156', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.55', 'ciLowerLimit': '-10.79', 'ciUpperLimit': '-4.30', 'groupDescription': 'LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Average daily bolus Insulin Dose at Week 26 was reported.', 'unitOfMeasure': 'Units per day of bolus insulin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Total Insulin Dose at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.'}], 'classes': [{'categories': [{'measurements': [{'value': '592.92', 'spread': '12.560', 'groupId': 'OG000'}, {'value': '666.43', 'spread': '12.144', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-73.50', 'ciLowerLimit': '-107.81', 'ciUpperLimit': '-39.20', 'groupDescription': 'LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Average total weekly insulin dose at Week 26 was reported.', 'unitOfMeasure': 'Units per week of insulin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Basal Insulin Dose to Total Insulin Dose Ratio at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.09', 'spread': '0.749', 'groupId': 'OG000'}, {'value': '66.55', 'spread': '0.722', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.53', 'ciLowerLimit': '1.49', 'ciUpperLimit': '5.58', 'groupDescription': 'LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': 'Basal insulin dose to total insulin dose ratio at Week 26 was reported.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Hypoglycemia Event Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.58', 'spread': '0.709', 'groupId': 'OG000'}, {'value': '5.94', 'spread': '0.618', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.442', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.44', 'groupDescription': 'Group mean was reported and determined by Negative binomial method using Baseline hypoglycemia rate + Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as variables.', 'statisticalMethod': 'Negative binomial model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 26', 'description': 'Hypoglycemia event rate was reported. Hypoglycemia with glucose \\<54 mg/dL (Level 2) or Severe Hypoglycemia (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. Group mean was reported here.', 'unitOfMeasure': 'Events per year', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.67', 'spread': '0.165', 'groupId': 'OG000'}, {'value': '2.53', 'spread': '0.165', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.543', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.60', 'groupDescription': 'LS Mean was determined by MMRM model using BASELINE + 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', 'description': 'Change from baseline in body weight was reported.', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable data for this outcome.'}, {'type': 'SECONDARY', 'title': 'Treatment Experience for Diabetes Injection Device at Week 26 - Experience Questionnaire (DID-EQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.'}, {'id': 'OG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.1', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '86.3', 'spread': '0.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.099', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '4.0', 'groupDescription': 'LS Mean was determined by ANCOVA model using Country + Personal Use CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 26', 'description': "The DID-EQ is a self-administered, 10-item questionnaire designed to assess participants' perceptions of diabetes injection delivery systems for diabetes. The Device Characteristic Subscale is comprised of items 1 to 7 which focus on specific characteristics of injection devices. Each item is rated on a four-point Likert scale. Scores are transformed and range from 0 to 100. Higher scores indicate more positive perceptions of injection device characteristics", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable data for this outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW) along with 100 U/mL insulin lispro given SC.'}, {'id': 'FG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC once daily (QD) along with 100 U/mL insulin lispro given SC.'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '365'}, {'groupId': 'FG001', 'numSubjects': '365'}]}, {'type': 'Received At Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '365'}, {'groupId': 'FG001', 'numSubjects': '365'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '348'}, {'groupId': 'FG001', 'numSubjects': '344'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Assigned Treatment by Mistake', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}, {'title': 'Follow-Up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Per 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.', 'groupId': 'FG000', 'numSubjects': '357'}, {'comment': 'Per 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.', 'groupId': 'FG001', 'numSubjects': '354'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '352'}, {'groupId': 'FG001', 'numSubjects': '349'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Participants underwent a 26-week treatment period, followed by a 5-week safety follow-up period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '730', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 U/mL insulin efsitora administered SC QW along with 100 U/mL insulin lispro given SC.'}, {'id': 'BG001', 'title': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC QD along with 100 U/mL insulin lispro given SC.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '730', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58.3', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '59.4', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '58.9', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '730', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '361', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '730', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '324', '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': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '730', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '105', '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': '20', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '245', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '503', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'Argentina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '730', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '730', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'India', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '730', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '730', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '730', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '730', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '365', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '730', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'HemoglobinA1c (HbA1c)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'BG000'}, {'value': '362', 'groupId': 'BG001'}, {'value': '723', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.17', 'spread': '0.83', 'groupId': 'BG000'}, {'value': '8.18', 'spread': '0.79', 'groupId': 'BG001'}, {'value': '8.18', 'spread': '0.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.', 'unitOfMeasure': 'Percentage of HbA1c', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All participants who received at least one dose of study drug and had baseline HbA1c value.'}], 'populationDescription': 'All participants who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-17', 'size': 1414482, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-13T06:35', 'hasProtocol': True}, {'date': '2024-03-18', 'size': 10162147, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-13T06:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 730}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2022-07-14', 'resultsFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2022-07-14', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-10', 'studyFirstPostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority]', 'timeFrame': 'Baseline, Week 26', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HbA1c [Superiority]', 'timeFrame': 'Baseline, Week 26', 'description': 'HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.'}, {'measure': 'Percentage of Participants Achieving HbA1c <7% Without Nocturnal Hypoglycemia', 'timeFrame': 'Week 26', 'description': 'Percentage of participants achieving HbA1c \\<7% without nocturnal hypoglycemia \\[\\<54 milligram/deciliter (mg/dL) 3.0 millimole/Liter (mmol/L)\\] or severe during treatment phase up to week 26. Nocturnal hypoglycemia is a hypoglycemia event, including severe hypoglycemia, that occurs at night and presumably during sleep between midnight and 6:00 am.'}, {'measure': 'Nocturnal Hypoglycemia Event Rate', 'timeFrame': 'Baseline Up To Week 26', 'description': 'The event rate of participant-reported clinically significant nocturnal hypoglycemia, (where glucose \\<54 mg/dL (3.0 mmol/L) or severe and occurs at night and presumably during sleep between midnight and 6:00 AM), measured during treatment phase up to week 26. Group mean is reported here.'}, {'measure': 'Change From Baseline in Fasting Glucose', 'timeFrame': 'Baseline, Week 26', 'description': 'Change from baseline in fasting glucose measured by self-monitoring blood glucose (SMBG).'}, {'measure': 'Percentage of Time in Glucose Range', 'timeFrame': 'Week 22 to Week 26', 'description': 'Percentage of Time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 mmol/L), inclusive measured during the continuous glucose monitoring (CGM) session.'}, {'measure': 'Percentage of Time in Hypoglycemia Range', 'timeFrame': 'Week 22 to Week 26', 'description': 'Percentage of Time in hypoglycemia range with glucose \\<54 mg/dL (3.0 mmol/L), measured by CGM.'}, {'measure': 'Percentage of Time in Hyperglycemia Range', 'timeFrame': 'Week 22 to Week 26', 'description': 'Percentage of Time in hyperglycemia range with glucose \\>180 mg/dL (10.0 mmol/L), measured by CGM.'}, {'measure': 'Glucose Variability Between Weeks 22 to 26', 'timeFrame': 'Week 22 to Week 26', 'description': 'Glucose variability measured as coefficient of variation for glucose within day for 24-hour period between Week 22 and 26 was reported.'}, {'measure': 'Basal Insulin Dose at Week 26', 'timeFrame': 'Week 26', 'description': 'Average weekly basal Insulin Dose at Week 26 was reported.'}, {'measure': 'Bolus Insulin Dose at Week 26', 'timeFrame': 'Week 26', 'description': 'Average daily bolus Insulin Dose at Week 26 was reported.'}, {'measure': 'Total Insulin Dose at Week 26', 'timeFrame': 'Week 26', 'description': 'Average total weekly insulin dose at Week 26 was reported.'}, {'measure': 'Basal Insulin Dose to Total Insulin Dose Ratio at Week 26', 'timeFrame': 'Week 26', 'description': 'Basal insulin dose to total insulin dose ratio at Week 26 was reported.'}, {'measure': 'Hypoglycemia Event Rate', 'timeFrame': 'Baseline up to Week 26', 'description': 'Hypoglycemia event rate was reported. Hypoglycemia with glucose \\<54 mg/dL (Level 2) or Severe Hypoglycemia (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. Group mean was reported here.'}, {'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'Baseline, Week 26', 'description': 'Change from baseline in body weight was reported.'}, {'measure': 'Treatment Experience for Diabetes Injection Device at Week 26 - Experience Questionnaire (DID-EQ)', 'timeFrame': 'Week 26', 'description': "The DID-EQ is a self-administered, 10-item questionnaire designed to assess participants' perceptions of diabetes injection delivery systems for diabetes. The Device Characteristic Subscale is comprised of items 1 to 7 which focus on specific characteristics of injection devices. Each item is rated on a four-point Likert scale. Scores are transformed and range from 0 to 100. Higher scores indicate more positive perceptions of injection device characteristics"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Type 2 Diabetes Treated With Insulin']}, 'referencesModule': {'references': [{'pmid': '40562048', 'type': 'DERIVED', 'citation': 'Blevins T, Dahl D, Perez Manghi FC, Murthy S, Ortiz Carrasquillo R, Li X, Chang AM, Carr MC, Katz M. Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial. Lancet. 2025 Jun 28;405(10497):2290-2301. doi: 10.1016/S0140-6736(25)01069-4. Epub 2025 Jun 22.'}], 'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/350915', 'label': 'A Study of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections (QWINT-4)'}]}, 'descriptionModule': {'briefSummary': 'The reason for this study is to evaluate if the once-weekly study drug insulin efsitora alfa (LY3209590) is safe and effective compared with daily insulin glargine in participants with Type 2 diabetes (T2D) that have already been treated with basal insulin and at least 2 injections per day of prandial insulin. The study consists of a 3-week screening/lead-in period, a 26-week treatment period and a 5-week safety follow-up period. The study will last up to 34 weeks.'}, '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 (WHO) criteria, currently treated with basal insulin and at least 2 injections of prandial insulin per day.\n* Are receiving ≥10 units of total basal insulin per day at screening.\n* Are receiving ≤2 units/kilogram/day of total daily insulin at screening\n* Have an HbA1c value of 7.0% to 10%, inclusive, as determined by the central laboratory at screening\n* Have been treated with a stable regimen of one of the following basal insulins used according to local product label with or without noninsulin diabetes therapy for at least 90 days prior to screening\n\n * once daily U-100 or U-200 insulin degludec\n * once daily U-100 or U-300 insulin glargine\n * once or twice daily U-100 insulin detemir or\n * once or twice daily human insulin Neutral Protamine Hagedorn\n* Have been treated with at least twice daily dosing of one of the following insulins used according to local product label for at least 90 days prior to screening. One dose of prandial insulin must occur at the evening meal.\n\n * Insulin lispro-aabc\n * Insulin lispro (U-100 and U-200)s, IN\\], U-100 or U200)\n * Insulin aspart (U-100)\n * Insulin glulisine (U-100), or\n * Regular insulin (U-100)\n* Acceptable noninsulin diabetes therapies may include 0 to up to 3 of the following with a stable dose for at least 90 days prior to screening\n\n * dipeptidyl peptidase IV inhibitors\n * sodium-glucose co-transporter-2 inhibitors\n * biguanides (for example, metformin), or\n * glucagon-like peptide-1 receptor agonists Note: All noninsulin diabetes therapies must be used in accordance with the corresponding local product label at the time of screening, and participants should be willing to continue stable dosing throughout the study\n * Have a body mass index ≤45 kilogram/square meter (kg/m²)\n\nExclusion Criteria:\n\n* Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes, or specific type of diabetes other than T2D (for example, monogenic diabetes, diseases of the exocrine pancreas, drug-induced or chemical-induced diabetes).\n* Are currently receiving any of the following insulin therapies anytime in the past 90 days:\n\n * insulin mixtures\n * insulin human, inhalation powder, or\n * continuous subcutaneous insulin infusion therapy, or\n * regular insulin U-500\n* Have a history of greater than 1 episode of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening\n* Have had any episodes of severe hypoglycemia, defined as requiring assistance due to neurologically disabling hypoglycemia, within the 6 months prior to screening\n* Have hypoglycemia unawareness in the opinion of the investigator\n* Anticipate making changes in personal CGM or flash glucose monitoring (FGM) use (for example, initiation, stopping, or changing device) during the study.\n* Have had New York Heart Association Class IV heart failure or any of the following cardiovascular conditions in the past 3 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or coronary bypass surgery.\n* Have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery, or sleeve gastrectomy within 1 year prior to screening'}, 'identificationModule': {'nctId': 'NCT05462756', 'acronym': 'QWINT-4', 'briefTitle': 'A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Parallel-Design, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adults With Type 2 Diabetes on Multiple Daily Injections', 'orgStudyIdInfo': {'id': '18260'}, 'secondaryIdInfos': [{'id': 'I8H-MC-BDCV', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2021-005878-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '500 U/mL - Insulin Efsitora', 'description': 'Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW) along with 100 U/mL insulin lispro given SC with meals as needed.', 'interventionNames': ['Drug: Insulin Efsitora Alfa', 'Drug: Insulin Lispro (U100)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '100 U/mL - Insulin Glargine', 'description': 'Participants received 100 U/mL insulin glargine administered SC once daily (QD) along with 100 U/mL insulin lispro given SC with meals as needed.', 'interventionNames': ['Drug: Insulin Lispro (U100)', 'Drug: Insulin Glargine (U100)']}], 'interventions': [{'name': 'Insulin Efsitora Alfa', 'type': 'DRUG', 'otherNames': ['LY3209590 and Basal Insulin-FC'], 'description': 'Administered SC', 'armGroupLabels': ['500 U/mL - Insulin Efsitora']}, {'name': 'Insulin Lispro (U100)', 'type': 'DRUG', 'otherNames': ['Humalog'], 'description': 'Administered SC', 'armGroupLabels': ['100 U/mL - Insulin Glargine', '500 U/mL - Insulin Efsitora']}, {'name': 'Insulin Glargine (U100)', 'type': 'DRUG', 'otherNames': ['Basaglar'], 'description': 'Administered SC', 'armGroupLabels': ['100 U/mL - Insulin Glargine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06517', 'city': 'Hamden', 'state': 'Connecticut', 'country': 'United States', 'facility': 'CMR of Greater New Haven, LLC', 'geoPoint': {'lat': 41.39593, 'lon': -72.89677}}, {'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa Bay Medical Research', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Panax Clinical Research', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Encore Medical Research - Weston', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '83221', 'city': 'Blackfoot', 'state': 'Idaho', 'country': 'United States', 'facility': 'Elite Clinical Trials', 'geoPoint': {'lat': 43.19047, 'lon': -112.34498}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Rocky Mountain Clinical Research', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '21239', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar Good Samaritan Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02721', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'NECCR PrimaCare Research', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Arcturus Healthcare , PLC, Troy Internal Medicine Research Division', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Palm Research Center Tenaya', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Palm Research Center Sunset', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '14221', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Research Foundation of SUNY - University of Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Remington Davis Clinical Research', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43016', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Aventiv Research', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '15009', 'city': 'Beaver', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Heritage Valley Multispecialty Group, Inc', 'geoPoint': {'lat': 40.69534, 'lon': -80.30478}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Diabetes & Endocrinology, P.A.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78749', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Diabetes & Endocrinology, P.A.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'North Texas Endocrine Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77043', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Biopharma Informatic, LLC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Institute of Dallas', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '78231', 'city': 'Shavano Park', 'state': 'Texas', 'country': 'United States', 'facility': 'Consano Clinical Research, LLC', 'geoPoint': {'lat': 29.58495, 'lon': -98.55252}}, {'zip': '84790', 'city': 'St. George', 'state': 'Utah', 'country': 'United States', 'facility': 'Chrysalis Clinical Research', 'geoPoint': {'lat': 37.10415, 'lon': -113.58412}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Rainier Clinical Research Center', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': 'C1060ABN', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'CEDIC'}, {'zip': '1056', 'city': 'Ciudad Autónoma de Buenos Aire', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Centro de Investigaciones Metabólicas (CINME)'}, {'zip': '2900', 'city': 'San Nicolás de los Arroyos', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Go Centro Medico San Nicolás', 'geoPoint': {'lat': -33.33425, 'lon': -60.2108}}, {'zip': 'C1128AAF', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Mautalen Salud e Investigación', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1061AAS', 'city': 'CABA', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'CIPREC'}, {'zip': 'C1405BUB', 'city': 'Ciudad Autonoma de Buenos Aire', 'state': 'Buenos Air', 'country': 'Argentina', 'facility': 'Consultorio de Investigación Clínica EMO SRL'}, {'zip': '1204', 'city': 'CABA', 'state': 'Ciudad Autónoma de Buenos Aire', 'country': 'Argentina', 'facility': 'Instituto Centenario'}, {'zip': 'C1425AGC', 'city': 'Ciudad Autonoma de Buenos Aire', 'state': 'Ciudad Autónoma de Buenos Aire', 'country': 'Argentina', 'facility': 'Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada'}, {'zip': '5800', 'city': 'Río Cuarto', 'state': 'Córdoba Province', 'country': 'Argentina', 'facility': 'Instituto Médico Río Cuarto', 'geoPoint': {'lat': -33.13044, 'lon': -64.35272}}, {'zip': '6300', 'city': 'Santa Rosa', 'state': 'La Pampa Province', 'country': 'Argentina', 'facility': 'Centro de Salud e Investigaciones Médicas', 'geoPoint': {'lat': -36.61617, 'lon': -64.28991}}, {'zip': '2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Instituto de Investigaciones Clinicas Rosario-Sanatorio Delta', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Instituto Médico Catamarca IMEC', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'T4000AXL', 'city': 'San Miguel de Tucumán', 'state': 'Tucumán Province', 'country': 'Argentina', 'facility': 'Centro de Investigaciones Médicas Tucuman', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': 'C1440AAD', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'CENUDIAB', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '5000', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Instituto de Investigaciones Clínicas Córdoba', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '3000', 'city': 'Santa Fe', 'country': 'Argentina', 'facility': 'Centro de Investigaciones Clinicas del Litoral', 'geoPoint': {'lat': -31.64881, 'lon': -60.70868}}, {'zip': '60596', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'ClinPhenomics GmbH & Co KG', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '45136', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'InnoDiab Forschung Gmbh', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '48145', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Institut für Diabetesforschung GmbH Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '48153', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '23758', 'city': 'Oldenburg in Holstein', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'RED-Institut GmbH', 'geoPoint': {'lat': 54.29498, 'lon': 10.89043}}, {'zip': '97980', 'city': 'Bad Mergentheim', 'country': 'Germany', 'facility': 'Diabetespraxis Mergentheim', 'geoPoint': {'lat': 49.4925, 'lon': 9.77361}}, {'zip': '22607', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Diabeteszentrum Hamburg West', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '560092', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Life Care Hospital and Research Centre', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '400008', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Topiwala National Medical College & B. Y. L. Nair Charitable Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400058', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'BSES MG Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '600086', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Madras Diabetes Research Foundation', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '500012', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'Osmania General Hospital', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '160012', 'city': 'Chandigarh', 'country': 'India', 'facility': 'Post Graduate Institute of Medical Education & Research (PGIMER)', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}, {'zip': '03023', 'city': 'Ceccano', 'state': 'Frosinone', 'country': 'Italy', 'facility': 'Osepdale Civile Fr 5', 'geoPoint': {'lat': 41.57236, 'lon': 13.32901}}, {'zip': '00186', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': '"Fatebenefratelli Isola Tiberina - Gemelli Isola"', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '07026', 'city': 'Olbia', 'state': 'Sardinia', 'country': 'Italy', 'facility': 'Ospedale san Giovanni di Dio-Diabetologia', 'geoPoint': {'lat': 40.92337, 'lon': 9.49802}}, {'zip': '60125', 'city': 'Ancona', 'country': 'Italy', 'facility': 'INRCA Ancona', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'IRCCS - AOU di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '25123', 'city': 'Brescia', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Mater Domini', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '90127', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '44670', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Private Practice - Dr. Arechavaleta Granell Maria del Rosario', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '44670', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Unidad de Investigación Clínica y Atención Médica HEPA', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '66460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Hospital Universitario "Dr. Jose Eleuterio Gonzalez"', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '66465', 'city': 'San Nicolás de los Garza', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Unidad Médica para la Salud Integral', 'geoPoint': {'lat': 25.74167, 'lon': -100.30222}}, {'zip': '89440', 'city': 'Ciudad Madero', 'state': 'Tamaulipas', 'country': 'Mexico', 'facility': 'Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.', 'geoPoint': {'lat': 22.2475, 'lon': -97.83665}}, {'zip': '31217', 'city': 'Chihuahua City', 'country': 'Mexico', 'facility': 'Investigacion En Salud Y Metabolismo Sc', 'geoPoint': {'lat': 28.63528, 'lon': -106.08889}}, {'zip': '00959', 'city': 'Bayamón', 'country': 'Puerto Rico', 'facility': 'Centro de Endocrinologia Alcantara Gonzalez', 'geoPoint': {'lat': 18.39856, 'lon': -66.15572}}, {'zip': '00674', 'city': 'Manatí', 'country': 'Puerto Rico', 'facility': 'Manati Center for Clinical Research', 'geoPoint': {'lat': 18.42745, 'lon': -66.49212}}, {'zip': '15006', 'city': 'A Coruña', 'state': 'A Coruña [La Coruña]', 'country': 'Spain', 'facility': 'CHUAC-Complejo Hospitalario Universitario A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '15405', 'city': 'Ferrol', 'state': 'A Coruña [La Coruña]', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval', 'geoPoint': {'lat': 43.48451, 'lon': -8.23293}}, {'zip': '29010', 'city': 'Málaga', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '07120', 'city': 'Palma', 'state': 'Balears [Baleares]', 'country': 'Spain', 'facility': 'Hospital Universitari Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '47010', 'city': 'Valladolid', 'state': 'Castille and León', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '08041', 'city': 'Barcelona', 'state': 'Catalunya [Cataluña]', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28223', 'city': 'Pozuelo de Alarcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Quironsalud Madrid', 'geoPoint': {'lat': 40.43293, 'lon': -3.81338}}, {'zip': '41950', 'city': 'Seville', 'state': 'Sevilla', 'country': 'Spain', 'facility': 'Vithas Hospital Sevilla', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46600', 'city': 'Alzira', 'state': 'Valenciana, Comunitat', 'country': 'Spain', 'facility': 'Hospital Universitario de La Ribera', 'geoPoint': {'lat': 39.15, 'lon': -0.43333}}, {'zip': '46014', 'city': 'Valencia', 'state': 'Valenciana, Comunitat', 'country': 'Spain', 'facility': 'Hospital General Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '18016', 'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '41003', 'city': 'Seville', 'country': 'Spain', 'facility': 'Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) Mon- Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'http://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES', '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'}}}}