Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-30 @ 7:16 PM
Study NCT ID:
NCT00377858
Status:
COMPLETED
Last Update Posted:
2009-12-09
First Post:
2006-09-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX)
Sponsor:
Organization:
Raw JSON
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'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Insulin Lispro Mid Mixture', 'description': 'Insulin lispro mid mixture (MM) up to three times a day (TID)', 'otherNumAtRisk': 239, 'otherNumAffected': 91, 'seriousNumAtRisk': 239, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.', 'otherNumAtRisk': 240, 'otherNumAffected': 92, 'seriousNumAtRisk': 240, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': 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{'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 31, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 22, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Coronary artery disease', 'notes': 'Death (insulin glargine patient)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acetabulum fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ilium fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypoglycaemic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary oedema', 'notes': 'Death (insulin glargine patient)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Angiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arterial disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 239, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hemoglobin A1c (HbA1c) at 36 Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Lispro Mid Mixture', 'description': 'Insulin lispro mid mixture (MM) up to three times a day (TID)'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.66', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '7.49', 'spread': '0.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.097', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.37', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for (Insulin Lispro Mid Mixture minus Insulin Glargine).', 'groupDescription': 'Assuming 15% drop-out rate after randomization, remaining 213 patients in each treatment group would allow confirmation of noninferiority with no treatment difference and a noninferiority limit of 0.3% using upper limit of 2-sided confidence interval at significance level of 0.05 with 80% power.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline HbA1c Stratum + Sulfonylurea stratum + Country + Baseline HbA1c Stratum.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Noninferiority margin of 0.3% based on prior studies indicating an HbA1c difference of 0.6% in patients treated with lispro and sulfonylurea compared with those treated with sulfonylurea and metformin.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '36 weeks', 'description': 'Level of hemoglobin A1c at endpoint.', 'unitOfMeasure': 'percent HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in the per-protocol population. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Hemoglobin A1c (HbA1c) at Interval Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Lispro Mid Mixture', 'description': 'Insulin lispro mid mixture (MM) up to three times a day (TID)'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.'}], 'classes': [{'title': '12 Week Interval (n=222, n=222)', 'categories': [{'measurements': [{'value': '8.02', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '7.85', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': '24 Week Interval (n=206, n=217)', 'categories': [{'measurements': [{'value': '7.53', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '7.36', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': '36 Week Interval (n=202, n=208)', 'categories': [{'measurements': [{'value': '7.53', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '7.44', 'spread': '0.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.33', 'pValueComment': 'P-value for 12 Week Interval.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.', 'testedNonInferiority': False}, {'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.35', 'pValueComment': 'P-value for 24 Week Interval.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.', 'testedNonInferiority': False}, {'pValue': '0.343', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.29', 'pValueComment': 'P-value for 36 Week Interval.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12, 24, and 36 weeks', 'description': 'Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks.', 'unitOfMeasure': 'percent HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Lispro Mid Mixture', 'description': 'Insulin lispro mid mixture (MM) up to three times a day (TID)'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.'}], 'classes': [{'title': 'Week 12: HbA1c ≤7.0% (n=222, n=222)', 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000'}, {'value': '25.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: HbA1c >7.0% (n=222, n=222)', 'categories': [{'measurements': [{'value': '78.8', 'groupId': 'OG000'}, {'value': '74.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: HbA1c <7.0% (n=222, n=222)', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000'}, {'value': '21.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: HbA1c ≥7.0% (n=222, n=222)', 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000'}, {'value': '78.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: HbA1c ≤6.5% (n=222, n=222)', 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '10.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: HbA1c >6.5% (n=222, n=222)', 'categories': [{'measurements': [{'value': '91.9', 'groupId': 'OG000'}, {'value': '89.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: HbA1c ≤7.0% (n=206, n=217)', 'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000'}, {'value': '47.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: HbA1c >7.0% (n=206, n=217)', 'categories': [{'measurements': [{'value': '60.2', 'groupId': 'OG000'}, {'value': '53.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: HbA1c <7.0% (n=206, n=217)', 'categories': [{'measurements': [{'value': '35.4', 'groupId': 'OG000'}, {'value': '38.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: HbA1c ≥7.0% (n=206, n=217)', 'categories': [{'measurements': [{'value': '64.6', 'groupId': 'OG000'}, {'value': '61.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: HbA1c ≤6.5% (n=206, n=217)', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: HbA1c >6.5% (n=206, n=217)', 'categories': [{'measurements': [{'value': '84.0', 'groupId': 'OG000'}, {'value': '78.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 36: HbA1c ≤7.0% (n=202, n=208)', 'categories': [{'measurements': [{'value': '39.6', 'groupId': 'OG000'}, {'value': '44.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 36: HbA1c >7.0% (n=202, n=208)', 'categories': [{'measurements': [{'value': '60.4', 'groupId': 'OG000'}, {'value': '55.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 36: HbA1c <7.0% (n=202, n=208)', 'categories': [{'measurements': [{'value': '37.6', 'groupId': 'OG000'}, {'value': '40.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 36: HbA1c ≥7.0% (n=202, n=208)', 'categories': [{'measurements': [{'value': '62.4', 'groupId': 'OG000'}, {'value': '59.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 36: HbA1c ≤6.5% (n=202, n=208)', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '19.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 36: HbA1c >6.5% (n=202, n=208)', 'categories': [{'measurements': [{'value': '84.7', 'groupId': 'OG000'}, {'value': '80.8', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint (LOCF): HbA1c ≤7.0% (n=234, n=235)', 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000'}, {'value': '43.0', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint (LOCF): HbA1c >7.0% (n=234, n=235)', 'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000'}, {'value': '57.0', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint (LOCF): HbA1c <7.0% (n=234, n=235)', 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000'}, {'value': '39.1', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint (LOCF): HbA1c ≥7.0% (n=234, n=235)', 'categories': [{'measurements': [{'value': '65.0', 'groupId': 'OG000'}, {'value': '60.9', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint (LOCF): HbA1c ≤6.5% (n=234, n=235)', 'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000'}, {'value': '19.1', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint (LOCF): HbA1c >6.5% (n=234, n=235)', 'categories': [{'measurements': [{'value': '86.8', 'groupId': 'OG000'}, {'value': '80.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.432', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Week 12: HbA1c ≤7.0%.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.', 'testedNonInferiority': False}, {'pValue': '0.602', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for 12 Week: HbA1c \\<7.0%.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.', 'testedNonInferiority': False}, {'pValue': '0.370', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for 12 Week: HbA1c ≤6.5%.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.', 'testedNonInferiority': False}, {'pValue': '0.198', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for 24 Week: HbA1c ≤7.0%.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.', 'testedNonInferiority': False}, {'pValue': '0.636', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for 24 Week: HbA1c \\<7.0%.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.', 'testedNonInferiority': False}, {'pValue': '0.185', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for 24 Week: HbA1c ≤6.5%.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.', 'testedNonInferiority': False}, {'pValue': '0.393', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for 36 Week: HbA1c ≤7.0%.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.', 'testedNonInferiority': False}, {'pValue': '0.739', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for 36 Week: HbA1c \\<7.0%.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.', 'testedNonInferiority': False}, {'pValue': '0.396', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for 36 Week: HbA1c ≤6.5%.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.', 'testedNonInferiority': False}, {'pValue': '0.227', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Endpoint (LOCF): HbA1c ≤7.0%.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.', 'testedNonInferiority': False}, {'pValue': '0.482', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Endpoint (LOCF): HbA1c \\<7.0%.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.', 'testedNonInferiority': False}, {'pValue': '0.108', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Endpoint (LOCF): HbA1c ≤6.5%.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12-24-36 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).'}, {'type': 'SECONDARY', 'title': '7-point Self-monitored Blood Glucose Profiles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Lispro Mid Mixture', 'description': 'Insulin lispro mid mixture (MM) up to three times a day (TID)'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.'}], 'classes': [{'title': 'Baseline: Morning Pre-Meal (n=228, n=231)', 'categories': [{'measurements': [{'value': '10.22', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '9.64', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Morning Postprandial Meal (n=213, n=222)', 'categories': [{'measurements': [{'value': '12.49', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '12.39', 'spread': '1.16', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Midday Pre-Meal (n=227, n=230)', 'categories': [{'measurements': [{'value': '10.15', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '9.62', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Midday Postprandial Meal (n=215, n=223)', 'categories': [{'measurements': [{'value': '11.40', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '11.22', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Evening Pre-Meal (n=227, n=229)', 'categories': [{'measurements': [{'value': '10.38', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '10.31', 'spread': '1.07', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Evening Postprandial Meal (n=226,n= 229)', 'categories': [{'measurements': [{'value': '11.87', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '11.76', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 0300 Hours (n=205, n=202)', 'categories': [{'measurements': [{'value': '9.37', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '9.17', 'spread': '1.06', 'groupId': 'OG001'}]}]}, {'title': '12 Week: Morning Pre-Meal (n=218, n=226)', 'categories': [{'measurements': [{'value': '7.26', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '6.68', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': '12 Week: Morning Postprandial Meal (n=192, n=206)', 'categories': [{'measurements': [{'value': '11.56', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '11.28', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': '12 Week: Midday Pre-Meal (n=215, n=220)', 'categories': [{'measurements': [{'value': '8.63', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '8.10', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': '12 Week: Midday Postprandial Meal (n=196, n=209)', 'categories': [{'measurements': [{'value': '9.92', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '9.43', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': '12 Week: Evening Pre-Meal (n=216, n=221)', 'categories': [{'measurements': [{'value': '8.75', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '7.98', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': '12 Week: Evening Postprandial Meal (n=213, n= 223)', 'categories': [{'measurements': [{'value': '8.23', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '9.40', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': '12 Week: 0300 Hours (n=185, n=187)', 'categories': [{'measurements': [{'value': '6.97', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '7.12', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': '24 Week: Morning Pre-Meal (n=210, n=213)', 'categories': [{'measurements': [{'value': '6.72', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '6.07', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': '24 Week: Morning Postprandial Meal (n=193, n=201)', 'categories': [{'measurements': [{'value': '9.87', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '9.45', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': '24 Week: Midday Pre-Meal (n=209, n=213)', 'categories': [{'measurements': [{'value': '7.99', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '7.82', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': '24 Week: Midday Postprandial Meal (n=196, n=203)', 'categories': [{'measurements': [{'value': '9.38', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '9.15', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': '24 Week: Evening Pre-Meal (n=209, n=211)', 'categories': [{'measurements': [{'value': '7.50', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '6.94', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': '24 Week: Evening Postprandial Meal (n=207, n= 207)', 'categories': [{'measurements': [{'value': '8.21', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '8.69', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': '24 Week: 0300 Hours (n=181, n=184)', 'categories': [{'measurements': [{'value': '7.14', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '7.18', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': '36 Week: Morning Pre-Meal (n=200, n=210)', 'categories': [{'measurements': [{'value': '6.96', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '6.48', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': '36 Week: Morning Postprandial Meal (n=179, n=194)', 'categories': [{'measurements': [{'value': '10.09', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '10.29', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': '36 Week: Midday Pre-Meal (n=199, n=210)', 'categories': [{'measurements': [{'value': '7.33', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '7.46', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': '36 Week: Midday Postprandial Meal (n=182, n=195)', 'categories': [{'measurements': [{'value': '10.31', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '10.30', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': '36 Week: Evening Pre-Meal (n=199, n=207)', 'categories': [{'measurements': [{'value': '8.13', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '7.97', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': '36 Week: Evening Postprandial Meal (n=195, n= 225)', 'categories': [{'measurements': [{'value': '9.46', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '9.85', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': '36 Week: 0300 Hours (n=167, n=177)', 'categories': [{'measurements': [{'value': '8.18', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '8.25', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint: Morning Pre-Meal (n=228, n=231)', 'categories': [{'measurements': [{'value': '6.98', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '6.53', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint: Morning Postprandial Meal (n=213, n=222)', 'categories': [{'measurements': [{'value': '9.98', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '10.29', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint: Midday Pre-Meal (n=227, n=230)', 'categories': [{'measurements': [{'value': '7.36', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '7.52', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint: Midday Postprandial Meal (n=215, n=223)', 'categories': [{'measurements': [{'value': '10.28', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '10.34', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint: Evening Pre-Meal (n=227, n=229)', 'categories': [{'measurements': [{'value': '8.15', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '7.98', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint: Evening Postprandial Meal (n=226,n= 229)', 'categories': [{'measurements': [{'value': '9.27', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '9.84', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint: 0300 Hours (n=205, n=202)', 'categories': [{'measurements': [{'value': '7.78', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '7.89', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.12', 'ciUpperLimit': '1.04', 'pValueComment': 'P-value for Baseline: Morning Pre-Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.735', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.72', 'pValueComment': 'P-value for Baseline: Morning Postprandial Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.051', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '-0.00', 'ciUpperLimit': '1.08', 'pValueComment': 'P-value for Baseline: Midday Pre-Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.536', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.75', 'pValueComment': 'P-value for Baseline: Midday Postprandial Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.793', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.62', 'pValueComment': 'P-value for Baseline: Evening Pre-Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.693', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '0.64', 'pValueComment': 'P-value for Baseline: Evening Postprandial Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.499', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.77', 'pValueComment': 'P-value for Baseline: 0300 Hours.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.26', 'ciUpperLimit': '0.92', 'pValueComment': 'P-value for 12 Week: Morning Pre-Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.278', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.78', 'pValueComment': 'P-value for 12 Week: Morning Postprandial Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.93', 'pValueComment': 'P-value for 12 Week: Midday Pre-Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.49', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.97', 'pValueComment': 'P-value for 12 Week: Midday Postprandial Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.18', 'pValueComment': 'P-value for 12 Week: Evening Pre-Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-1.17', 'ciLowerLimit': '-1.63', 'ciUpperLimit': '-0.70', 'pValueComment': 'P-value for 12 Week: Evening Postprandial Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.506', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '0.29', 'pValueComment': 'P-value for 12 Week: 0300 Hours.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.31', 'ciUpperLimit': '0.99', 'pValueComment': 'P-value for 24 Week: Morning Pre-Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.094', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.91', 'pValueComment': 'P-value for 24 Week: Morning Postprandial Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.408', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.59', 'pValueComment': 'P-value for 24 Week: Midday Pre-Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.351', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.71', 'pValueComment': 'P-value for 24 Week: Midday Postprandial Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '0.13', 'ciUpperLimit': '0.98', 'pValueComment': 'P-value for 24 Week: Evening Pre-Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '-0.05', 'pValueComment': 'P-value for 24 Week: Evening Postprandial Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.816', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.35', 'pValueComment': 'P-value for 24 Week: 0300 Hours.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.49', 'ciLowerLimit': '0.13', 'ciUpperLimit': '0.85', 'pValueComment': 'P-value for 36 Week: Morning Pre-Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.438', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.31', 'pValueComment': 'P-value for 36 Week: Morning Postprandial Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.548', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.29', 'pValueComment': 'P-value for 36 Week: Midday Pre-Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.964', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.52', 'pValueComment': 'P-value for 36 Week: Midday Postprandial Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.453', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.60', 'pValueComment': 'P-value for 36 Week: Evening Pre-Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.096', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '0.07', 'pValueComment': 'P-value for 36 Week: Evening Postprandial Meal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.770', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.37', 'pValueComment': 'P-value for 36 Week: 0300 Hours.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '0.11', 'ciUpperLimit': '0.80', 'pValueComment': 'P-value for Endpoint: Morning Pre-Meal. (last observation carried forward)', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.201', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '0.17', 'pValueComment': 'P-value for Endpoint: Morning Postprandial Meal. (last observation carried forward)', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.430', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.24', 'pValueComment': 'P-value for Endpoint: Midday Pre-Meal. (last observation carried forward)', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.814', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.41', 'pValueComment': 'P-value for Endpoint: Midday Postprandial Meal. (last observation carried forward)', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.427', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.57', 'pValueComment': 'P-value for Endpoint: Evening Pre-Meal. (last observation carried forward)', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '-0.14', 'pValueComment': 'P-value for Endpoint: Evening Postprandial Meal. (last observation carried forward)', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.569', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.28', 'pValueComment': 'P-value for Endpoint: 0300 Hours. (last observation carried forward)', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12-24-36 weeks', 'description': 'Actual daily mean blood glucose levels at specified time points.', 'unitOfMeasure': 'millimoles per Liter (mmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).'}, {'type': 'SECONDARY', 'title': 'Glycemic Variability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Lispro Mid Mixture', 'description': 'Insulin lispro mid mixture (MM) up to three times a day (TID)'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.'}], 'classes': [{'title': 'Baseline MODD (n=226, n=229)', 'categories': [{'measurements': [{'value': '2.09', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '2.07', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Baseline M-Value (n=228, n=231)', 'categories': [{'measurements': [{'value': '48.02', 'spread': '14.73', 'groupId': 'OG000'}, {'value': '46.75', 'spread': '14.47', 'groupId': 'OG001'}]}]}, {'title': '12 Week MODD (n=214, n=221)', 'categories': [{'measurements': [{'value': '1.51', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': '12 Week M-Value (n=218, n=226)', 'categories': [{'measurements': [{'value': '30.07', 'spread': '7.24', 'groupId': 'OG000'}, {'value': '28.49', 'spread': '7.12', 'groupId': 'OG001'}]}]}, {'title': '24 Week MODD (n=208, n=211)', 'categories': [{'measurements': [{'value': '1.57', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '1.66', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': '24 Week M-Value (n=210, n=213)', 'categories': [{'measurements': [{'value': '22.67', 'spread': '7.05', 'groupId': 'OG000'}, {'value': '20.14', 'spread': '6.93', 'groupId': 'OG001'}]}]}, {'title': '36 Week MODD (n=198, n=206)', 'categories': [{'measurements': [{'value': '1.55', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '1.60', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': '36 Week M-Value (n=200, n=210)', 'categories': [{'measurements': [{'value': '26.46', 'spread': '7.26', 'groupId': 'OG000'}, {'value': '27.41', 'spread': '7.12', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint MODD (n=226, n=229)', 'categories': [{'measurements': [{'value': '1.51', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '1.61', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint M-Value (n=228, n=231)', 'categories': [{'measurements': [{'value': '26.27', 'spread': '7.41', 'groupId': 'OG000'}, {'value': '27.99', 'spread': '7.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.776', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.19', 'pValueComment': 'P-value for Baseline MODD.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.737', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '-6.14', 'ciUpperLimit': '8.68', 'pValueComment': 'P-value for Baseline M-Value.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.701', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.13', 'pValueComment': 'P-value for 12 Week MODD.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.400', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '1.58', 'ciLowerLimit': '-2.11', 'ciUpperLimit': '5.27', 'pValueComment': 'P-value for 12 Week M-Value.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.321', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.09', 'pValueComment': 'P-value for 24 Week MODD.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.179', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '2.52', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '6.21', 'pValueComment': 'P-value for 24 Week M-Value.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.573', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.12', 'pValueComment': 'P-value for 36 Week MODD.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.629', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.95', 'ciLowerLimit': '-4.79', 'ciUpperLimit': '2.90', 'pValueComment': 'P-value for 36 Week M-Value.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.250', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.07', 'pValueComment': 'P-value for Endpoint MODD. (last observation carried forward)', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.362', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-1.72', 'ciLowerLimit': '-5.44', 'ciUpperLimit': '1.99', 'pValueComment': 'P-value for Endpoint M-Value.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 12-24-36 weeks', 'description': 'Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.', 'unitOfMeasure': 'millimoles per liter (mmol/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).'}, {'type': 'SECONDARY', 'title': 'Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Lispro Mid Mixture', 'description': 'Insulin lispro mid mixture (MM) up to three times a day (TID)'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.'}], 'classes': [{'title': 'Endpoint Hypoglycemic Episodes', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'Overall Hypoglycemic Episodes', 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint Nocturnal Hypoglycemic Episodes', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Overall Nocturnal Hypoglycemic Episodes', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint Non-Nocturnal Hypoglycemic Episodes', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Overall Non-Nocturnal Hypoglycemic Episodes', 'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.094', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Endpoint Hypoglycemic Episodes.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Overall Hypoglycemic Episodes.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.430', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Endpoint Nocturnal Hypoglycemic Episodes.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Overall Nocturnal Hypoglycemic Episodes.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Endpoint Non-Nocturnal Hypoglycemic Episodes.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.756', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Overall Non-Nocturnal Hypoglycemic Episodes.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 36 Weeks', 'description': 'Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level \\<70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. The last visit of trial interval was used to calculate hypoglycemic episodes at Endpoint if patient completes trial and last observation carried forward was used if the patient dropped out of the study early.'}, {'type': 'SECONDARY', 'title': '30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Lispro Mid Mixture', 'description': 'Insulin lispro mid mixture (MM) up to three times a day (TID)'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.'}], 'classes': [{'title': 'Endpoint Hypoglycemic Rate', 'categories': [{'measurements': [{'value': '1.57', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '3.60', 'groupId': 'OG001'}]}]}, {'title': 'Overall Hypoglycemic Rate', 'categories': [{'measurements': [{'value': '1.88', 'spread': '2.44', 'groupId': 'OG000'}, {'value': '2.21', 'spread': '2.87', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint Nocturnal Hypoglycemic Rate', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Overall Nocturnal Hypoglycemic Rate', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint Non-Nocturnal Hypoglycemic Rate', 'categories': [{'measurements': [{'value': '1.31', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '1.87', 'spread': '3.29', 'groupId': 'OG001'}]}]}, {'title': 'Overall Non-Nocturnal Hypoglycemic Rate', 'categories': [{'measurements': [{'value': '1.63', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '2.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Endpoint Hypoglycemic Rate.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.', 'testedNonInferiority': False}, {'pValue': '0.218', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Overall Hypoglycemic Rate.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.', 'testedNonInferiority': False}, {'pValue': '0.311', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Endpoint Nocturnal Hypoglycemic Rate.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.', 'testedNonInferiority': False}, {'pValue': '0.615', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Overall Nocturnal Hypoglycemic Rate.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.', 'testedNonInferiority': False}, {'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Endpoint Non-Nocturnal Hypoglycemic Rate.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.', 'testedNonInferiority': False}, {'pValue': '0.255', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Overall Non-Nocturnal Hypoglycemic Rate.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 36 Weeks', 'description': 'Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level \\<70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.', 'unitOfMeasure': 'hypoglycemic event per 30 days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. The last visit of trial interval was used to calculate hypoglycemic episodes at Endpoint if patient completes trial and last observation carried forward was used if the patient dropped out of the study early.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With at Least One Severe Hypoglycemia Episode', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Lispro Mid Mixture', 'description': 'Insulin lispro mid mixture (MM) up to three times a day (TID)'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.'}], 'classes': [{'title': 'Endpoint Severe Hypoglycemic Episodes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Overall Severe Hypoglycemic Episodes', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.416', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Overall Severe Hypoglycemic Episodes.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 36 Weeks', 'description': 'Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose \\<2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident. The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Lispro Mid Mixture', 'description': 'Insulin lispro mid mixture (MM) up to three times a day (TID)'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.'}], 'classes': [{'title': 'Daily Basal (n=239, n=240)', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Daily Prandial (n=239, n=130)', 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Daily Total (n=239, n=240)', 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '-0.05', 'pValueComment': 'P-value for Daily Basal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.11', 'pValueComment': 'P-value for Daily Prandial.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.12', 'pValueComment': 'P-value for Daily Total.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '36 Weeks', 'description': 'Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day \\[U/kg/day\\]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.', 'unitOfMeasure': 'U/kg/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Endpoint Insulin Dose; Total, Basal, and Prandial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Lispro Mid Mixture', 'description': 'Insulin lispro mid mixture (MM) up to three times a day (TID)'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.'}], 'classes': [{'title': 'Daily Basal (n=239, n=240)', 'categories': [{'measurements': [{'value': '19.90', 'spread': '5.46', 'groupId': 'OG000'}, {'value': '26.86', 'spread': '5.37', 'groupId': 'OG001'}]}]}, {'title': 'Daily Prandial (n=239, n=130)', 'categories': [{'measurements': [{'value': '27.73', 'spread': '6.23', 'groupId': 'OG000'}, {'value': '21.68', 'spread': '6.19', 'groupId': 'OG001'}]}]}, {'title': 'Daily Total (n=239, n=240)', 'categories': [{'measurements': [{'value': '43.44', 'spread': '8.65', 'groupId': 'OG000'}, {'value': '38.25', 'spread': '8.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-6.96', 'ciLowerLimit': '-9.65', 'ciUpperLimit': '-4.26', 'pValueComment': 'P-value for Daily Basal.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '6.05', 'ciLowerLimit': '3.39', 'ciUpperLimit': '8.71', 'pValueComment': 'P-value for Daily Prandial.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '5.20', 'ciLowerLimit': '0.93', 'ciUpperLimit': '9.46', 'pValueComment': 'P-value for Daily Total.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '36 Weeks', 'description': 'Total daily insulin dose (Units of insulin per day \\[U/day\\]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.', 'unitOfMeasure': 'U/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Number of Insulin Injections Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Lispro Mid Mixture', 'description': 'Insulin lispro mid mixture (MM) up to three times a day (TID)'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.33', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '1.97', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '1.76', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 30', 'categories': [{'measurements': [{'value': '2.05', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '1.81', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '2.03', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint', 'categories': [{'measurements': [{'value': '1.98', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '1.79', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '0.24', 'ciUpperLimit': '0.42', 'pValueComment': 'P-value for Week 12.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.36', 'pValueComment': 'P-value for Week 24.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '0.09', 'ciUpperLimit': '0.40', 'pValueComment': 'P-value for Week 30.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.38', 'pValueComment': 'P-value for Week 36.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.', 'testedNonInferiority': False}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.34', 'pValueComment': 'P-value for Endpoint. (last observation carried forward)', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 12, 24, 30, 36', 'unitOfMeasure': 'insulin injections', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Absolute Body Weight at 36 Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Lispro Mid Mixture', 'description': 'Insulin lispro mid mixture (MM) up to three times a day (TID)'}, {'id': 'OG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '76.71', 'spread': '5.09', 'groupId': 'OG000'}, {'value': '77.00', 'spread': '5.01', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '3.09', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '3.19', 'spread': '1.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.803', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '0.62', 'pValueComment': 'P-value for Change from Baseline.', 'estimateComment': 'The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA Model: Variable=Treatment + Baseline + Sulfonylurea stratum + Country + Baseline HbA1c stratum.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 36 Weeks', 'description': 'Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Lispro Mid Mixture', 'description': 'Insulin lispro mid mixture (MM) up to three times a day (TID)'}, {'id': 'FG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '242'}, {'groupId': 'FG001', 'numSubjects': '242'}]}, {'type': 'Had at Least One Post-Baseline Value', 'achievements': [{'groupId': 'FG000', 'numSubjects': '239'}, {'groupId': 'FG001', 'numSubjects': '240'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}, {'groupId': 'FG001', 'numSubjects': '215'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': '636 patients were screened; 128 were screen failures; 24 discontinued prior to randomization; 484 patients were randomized. Baseline Characteristics are provided for the Intent to Treat Population, which was defined as patients with baseline and at least one post-baseline value.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'BG000'}, {'value': '240', 'groupId': 'BG001'}, {'value': '479', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Lispro Mid Mixture', 'description': 'Insulin lispro mid mixture (MM) up to three times a day (TID)'}, {'id': 'BG001', 'title': 'Insulin Glargine', 'description': 'Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.40', 'spread': '9.21', 'groupId': 'BG000'}, {'value': '59.45', 'spread': '9.87', 'groupId': 'BG001'}, {'value': '58.92', 'spread': '9.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI) Group', 'classes': [{'title': 'BMI <25 kg/m^2', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'BMI ≥25 kg/m^2 and <30 kg/m^2', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}]}, {'title': 'BMI ≥30 kg/m^2', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared.', 'unitOfMeasure': 'participants'}, {'title': 'Duration of Diabetes Group', 'classes': [{'title': '<5 years', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': '≥5 years and ≤10 years', 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}]}, {'title': '>10 years', 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hemoglobin A1c (HbA1c) Group', 'classes': [{'title': '≤8.5% HbA1c', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}, {'title': '>8.5% HbA1c', 'categories': [{'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '352', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity', 'classes': [{'title': 'African', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}]}, {'title': 'East Asian', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}, {'title': 'West Asian (Indian sub-continent)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Height', 'classes': [{'categories': [{'measurements': [{'value': '163.27', 'spread': '9.27', 'groupId': 'BG000'}, {'value': '164.68', 'spread': '9.48', 'groupId': 'BG001'}, {'value': '163.98', 'spread': '9.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.51', 'spread': '4.76', 'groupId': 'BG000'}, {'value': '29.00', 'spread': '4.55', 'groupId': 'BG001'}, {'value': '29.25', 'spread': '4.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared.', 'unitOfMeasure': 'kilograms per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '78.85', 'spread': '15.50', 'groupId': 'BG000'}, {'value': '78.87', 'spread': '15.10', 'groupId': 'BG001'}, {'value': '78.86', 'spread': '15.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '10.86', 'spread': '5.54', 'groupId': 'BG000'}, {'value': '11.79', 'spread': '7.29', 'groupId': 'BG001'}, {'value': '11.33', 'spread': '6.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin A1c (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '9.55', 'spread': '1.18', 'groupId': 'BG000'}, {'value': '9.39', 'spread': '1.17', 'groupId': 'BG001'}, {'value': '9.47', 'spread': '1.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent HbA1c', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 484}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-04', 'studyFirstSubmitDate': '2006-09-11', 'resultsFirstSubmitDate': '2009-09-16', 'studyFirstSubmitQcDate': '2006-09-14', 'lastUpdatePostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-10-26', 'studyFirstPostDateStruct': {'date': '2006-09-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin A1c (HbA1c) at 36 Week Endpoint', 'timeFrame': '36 weeks', 'description': 'Level of hemoglobin A1c at endpoint.'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin A1c (HbA1c) at Interval Visits', 'timeFrame': '12, 24, and 36 weeks', 'description': 'Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks.'}, {'measure': 'Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint', 'timeFrame': '12-24-36 weeks'}, {'measure': '7-point Self-monitored Blood Glucose Profiles', 'timeFrame': 'Baseline, 12-24-36 weeks', 'description': 'Actual daily mean blood glucose levels at specified time points.'}, {'measure': 'Glycemic Variability', 'timeFrame': 'Baseline, 12-24-36 weeks', 'description': 'Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.'}, {'measure': 'Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia', 'timeFrame': 'Baseline to 36 Weeks', 'description': 'Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level \\<70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.'}, {'measure': '30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)', 'timeFrame': 'Baseline to 36 Weeks', 'description': 'Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level \\<70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.'}, {'measure': 'Number of Patients With at Least One Severe Hypoglycemia Episode', 'timeFrame': 'Baseline to 36 Weeks', 'description': 'Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose \\<2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident. The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.'}, {'measure': 'Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial', 'timeFrame': '36 Weeks', 'description': 'Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day \\[U/kg/day\\]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.'}, {'measure': 'Endpoint Insulin Dose; Total, Basal, and Prandial', 'timeFrame': '36 Weeks', 'description': 'Total daily insulin dose (Units of insulin per day \\[U/day\\]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.'}, {'measure': 'Number of Insulin Injections Per Day', 'timeFrame': 'Weeks 12, 24, 30, 36'}, {'measure': 'Change From Baseline in Absolute Body Weight at 36 Week Endpoint', 'timeFrame': 'Baseline, 36 Weeks', 'description': 'Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'type 2'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '23489710', 'type': 'DERIVED', 'citation': 'Hayes RP, Curtis B, Ilag L, Nelson DR, Wong M, Funnell M. Expectations about insulin therapy, perceived insulin-delivery system social acceptability, and insulin treatment satisfaction contribute to decreases in insulin therapy self-efficacy in patients with type 2 diabetes after 36 weeks insulin therapy. J Diabetes. 2013 Sep;5(3):358-67. doi: 10.1111/1753-0407.12037. Epub 2013 May 28.'}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have type 2 diabetes\n* Have been receiving oral antihyperglycemic medications (OAM) without insulin including at least two of the following at maximally tolerated doses, AND meet the minimum dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose, according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. The OAMs also must be used in accordance with the product label\n* Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%.\n\nExclusion Criteria:\n\n* Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label.\n* Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion.\n* Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks.\n* Have a body mass index greater than 40 kg/m2.\n* Have had more than one episode of severe hypoglycemia in the last24 weeks\n* Are pregnant, intend to be pregnant during the course of the study or are breastfeeding\n* Have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease'}, 'identificationModule': {'nctId': 'NCT00377858', 'acronym': 'IOOX', 'briefTitle': 'Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Comparison of Two Approaches to Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control on Oral Therapy: Comparison of Premixed Insulin Lispro Mid Mixture With Separate Basal and Bolus Insulin Injections', 'orgStudyIdInfo': {'id': '10936'}, 'secondaryIdInfos': [{'id': 'F3Z-MC-IOOX'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin Lispro Mid Mixture', 'description': 'Insulin lispro mid mixture (MM) up to three times a day (TID)', 'interventionNames': ['Drug: Insulin lispro mid mixture (MM)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Glargine', 'description': 'Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.', 'interventionNames': ['Drug: Insulin glargine']}], 'interventions': [{'name': 'Insulin lispro mid mixture (MM)', 'type': 'DRUG', 'otherNames': ['Humalog', 'Mid Mix'], 'description': 'Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks', 'armGroupLabels': ['Insulin Lispro Mid Mixture']}, {'name': 'Insulin glargine', 'type': 'DRUG', 'description': 'Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks', 'armGroupLabels': ['Insulin Glargine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5035', 'city': 'Keswick', 'state': 'South Australia', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -34.94178, 'lon': 138.57459}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '6160', 'city': 'Fremantle', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -32.05632, 'lon': 115.74557}}, {'zip': 'N6A 4L2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'J2G 1T7', 'city': 'Granby', 'state': 'Quebec', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.40008, 'lon': -72.73243}}, {'zip': 'J1G 5K2', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'S4P 0W5', 'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}, {'zip': '78200', 'city': 'Mantes-la-Jolie', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.99048, 'lon': 1.7167}}, {'zip': '06500', 'city': 'Menton', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.77649, 'lon': 7.50435}}, {'zip': '64000', 'city': 'Pau', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '31082', 'city': 'Toulouse', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31238', 'city': 'Chihuahua City', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 28.63528, 'lon': -106.08889}}, {'zip': '44620', 'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '163045', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '117036', 'city': 'Moscow', 'country': 'Russia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '193257', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '410-719', 'city': 'Goyang-Si/Kyunggi-Do', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '501-757', 'city': 'Kwangju', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.9122, 'lon': 127.1279}}, {'zip': '110-746', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03114', 'city': 'Alicante', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '04001', 'city': 'Almería', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'zip': '08017', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '48013', 'city': 'Bilbao', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'Eli Lilly'}}}}