Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-02-20 @ 6:45 PM
Study NCT ID:
NCT00420095
Status:
COMPLETED
Last Update Posted:
2009-06-17
First Post:
2007-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study for Patients With Diabetes Mellitus (IOPA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061268', 'term': 'Insulin Lispro'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Human Insulin Mix 30/70', 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.', 'otherNumAffected': 19, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Insulin Lispro Low Mix', 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.', 'otherNumAffected': 23, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diabetic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypoglycemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Insulin Mix 30/70', 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.'}, {'id': 'OG001', 'title': 'Insulin Lispro Low Mix', 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.91', 'spread': '1.158', 'groupId': 'OG000', 'lowerLimit': '7.67', 'upperLimit': '8.15'}, {'value': '7.96', 'spread': '1.373', 'groupId': 'OG001', 'lowerLimit': '7.72', 'upperLimit': '8.20'}]}]}], 'analyses': [{'pValue': '0.497', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.10', 'groupDescription': 'Mixed model where period, sequence, treatment are fixed effects and patient within sequence are random effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The Kenward-Roger approximation was used to estimate the denominator degrees of freedom. Adjusted means were presented.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority hypothesis testing where paired t-test for equivalence of means was used to estimate the sample size.\n\nPre-defined non-inferiority margin of 0.3%.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks of each treatment', 'description': 'Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment.', 'unitOfMeasure': 'percent of glycosylated hemoglobin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.'}, {'type': 'SECONDARY', 'title': 'Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Insulin Mix 30/70', 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.'}, {'id': 'OG001', 'title': 'Insulin Lispro Low Mix', 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.68', 'groupId': 'OG000', 'lowerLimit': '0.44', 'upperLimit': '0.93'}, {'value': '0.63', 'groupId': 'OG001', 'lowerLimit': '0.38', 'upperLimit': '0.88'}]}]}], 'analyses': [{'pValue': '0.497', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.20', 'pValueComment': 'All comparisons were conducted using a 2-sided significance level of 0.05.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted means', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at 12 weeks of each treatment', 'description': 'Changes in glycosylated hemoglobin reflect the change in average blood glucose level between baseline and 12 weeks of treatment. Change = Baseline - Endpoint.', 'unitOfMeasure': 'percent of glycosylated hemoglobin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Insulin Mix 30/70', 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.'}, {'id': 'OG001', 'title': 'Insulin Lispro Low Mix', 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.04', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '1.51'}, {'value': '1.18', 'groupId': 'OG001', 'lowerLimit': '0.71', 'upperLimit': '1.65'}]}]}], 'analyses': [{'pValue': '0.419', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.20', 'pValueComment': 'All comparisons were conducted using a 2-sided significance level of 0.05.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted means', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks of each treatment', 'description': 'Values obtained after at least an 8 hour fast. Change = Baseline - Endpoint', 'unitOfMeasure': 'millimoles/Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. LOCF within each period.'}, {'type': 'SECONDARY', 'title': 'Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Insulin Mix 30/70', 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.'}, {'id': 'OG001', 'title': 'Insulin Lispro Low Mix', 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.72', 'groupId': 'OG000', 'lowerLimit': '-6.05', 'upperLimit': '-3.38'}, {'value': '-4.56', 'groupId': 'OG001', 'lowerLimit': '-5.89', 'upperLimit': '-3.23'}]}]}], 'analyses': [{'pValue': '0.741', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-1.09', 'ciUpperLimit': '0.78', 'pValueComment': 'All comparisons were conducted using a 2-sided significance level of 0.05.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted means', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks of each treatment', 'description': 'Insulin lispro low mix was to be administered within 15 minutes of morning and evening meals. Human insulin mix 30/70 was to be administered within 30 minutes of morning and evening meals. Change = Baseline - Endpoint', 'unitOfMeasure': 'units of insulin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed. LOCF within each period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Insulin Mix 30/70', 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.'}, {'id': 'OG001', 'title': 'Insulin Lispro Low Mix', 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.'}], 'classes': [{'title': 'HbA1c <=7%', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <=6.5%', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.644', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for the HbA1c Percentage Criteria (7%)', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.672', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for the HbA1c Percentage Criteria (6.5%)', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks of each treatment', 'description': 'Number of patients in each treatment group achieving the target HbA1c value during 12 weeks of each treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all randomized patients who completed the study with no major protocol violations. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Parameters Significantly Different From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Insulin Mix 30/70', 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.'}, {'id': 'OG001', 'title': 'Insulin Lispro Low Mix', 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.'}], 'classes': [{'title': 'Hematology - Significantly Different from Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chemistry - Significantly Different from Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urinalysis - Significantly Different from Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 12 weeks of each treatment', 'description': 'Number of participants with laboratory parameters (hematology, chemistry, and urinalysis) that were significantly different from baseline after 12 weeks of each treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all randomized patients receiving at least one dose. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.'}, {'type': 'SECONDARY', 'title': 'Hypoglycemia Rate Per Participant Per 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Insulin Mix 30/70', 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.'}, {'id': 'OG001', 'title': 'Insulin Lispro Low Mix', 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000', 'lowerLimit': '0.19', 'upperLimit': '0.49'}, {'value': '0.37', 'groupId': 'OG001', 'lowerLimit': '0.22', 'upperLimit': '0.52'}]}]}], 'analyses': [{'pValue': '0.670', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.11', 'pValueComment': 'All comparisons were conducted using a 2-sided significance level of 0.05.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted means', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'over 12 weeks of each treatment period', 'description': 'Hypoglycemia rate per patient per 30 days = (number of reported hypogylcemia events/number of days within the period) \\* 30 days. Since this was a 2x2 cross-over design (2 treatments and 2 periods), then the hypogyclemia rate was calculated per patient for each of the 2 periods by treatment.', 'unitOfMeasure': 'events/30 days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all randomized patients who had at least one dose. Crossover study design allows for the comparison of the effect of two treatments on the same patients, each patient served as own control for between-treatment comparisons. The data from two periods were combined and analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Human Insulin Mix 30/70 First, Then Insulin Lispro Low Mix', 'description': 'Human insulin mix 30/70 for 12 weeks followed by insulin lispro low mix for 12 weeks'}, {'id': 'FG001', 'title': 'Insulin Lispro Low Mix First, Then Human Insulin Mix 30/70', 'description': 'Insulin lispro low mix for 12 weeks followed by human insulin mix 30/70 for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Human Insulin Mix 30/70 First, Then Insulin Lispro Low Mix', 'description': 'Human insulin mix 30/70 for 12 weeks followed by insulin lispro low mix for 12 weeks'}, {'id': 'BG001', 'title': 'Insulin Lispro Low Mix First, Then Human Insulin Mix 30/70', 'description': 'Insulin lispro low mix for 12 weeks followed by human insulin mix 30/70 for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.9', 'spread': '10.75', 'groupId': 'BG000'}, {'value': '54.5', 'spread': '10.75', 'groupId': 'BG001'}, {'value': '54.2', 'spread': '10.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Other Treatments for Diabetes Prior to Study', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity', 'classes': [{'title': 'Han - the main ethnic origin in China', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type of Diabetes', 'classes': [{'title': 'Type 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Type 2', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Fasting Blood Glucose', 'classes': [{'categories': [{'measurements': [{'value': '9.49', 'spread': '2.660', 'groupId': 'BG000'}, {'value': '9.15', 'spread': '3.200', 'groupId': 'BG001'}, {'value': '9.32', 'spread': '2.942', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimole/Liter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Glycosylated Hemoglobin', 'classes': [{'categories': [{'measurements': [{'value': '8.56', 'spread': '1.304', 'groupId': 'BG000'}, {'value': '8.59', 'spread': '1.573', 'groupId': 'BG001'}, {'value': '8.58', 'spread': '1.442', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent of glycosylated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '25.40', 'spread': '3.297', 'groupId': 'BG000'}, {'value': '24.58', 'spread': '2.754', 'groupId': 'BG001'}, {'value': '24.98', 'spread': '3.045', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index is an estimate of body fat based on body weight divided by body height squared.', 'unitOfMeasure': 'kilogram per meter squared', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '129.8', 'spread': '95.61', 'groupId': 'BG000'}, {'value': '130.3', 'spread': '78.31', 'groupId': 'BG001'}, {'value': '130.1', 'spread': '86.78', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Insulin Treatment', 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '37.41', 'groupId': 'BG000'}, {'value': '39.0', 'spread': '32.37', 'groupId': 'BG001'}, {'value': '38.8', 'spread': '34.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-09', 'studyFirstSubmitDate': '2007-01-05', 'resultsFirstSubmitDate': '2009-01-07', 'studyFirstSubmitQcDate': '2007-01-05', 'lastUpdatePostDateStruct': {'date': '2009-06-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-04-15', 'studyFirstPostDateStruct': {'date': '2007-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycosylated Hemoglobin (HbA1c) Value at 12 Week Endpoint', 'timeFrame': 'Baseline and 12 weeks of each treatment', 'description': 'Glycosylated hemoglobin reflects the average blood glucose level over the previous 12 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'Changes in Glycosylated Hemoglobin (HbA1c) From Baseline to 12 Weeks of Treatment', 'timeFrame': 'Baseline and at 12 weeks of each treatment', 'description': 'Changes in glycosylated hemoglobin reflect the change in average blood glucose level between baseline and 12 weeks of treatment. Change = Baseline - Endpoint.'}, {'measure': 'Change in Fasting Blood Glucose Values From Baseline to 12 Weeks of Treatment', 'timeFrame': 'Baseline and 12 weeks of each treatment', 'description': 'Values obtained after at least an 8 hour fast. Change = Baseline - Endpoint'}, {'measure': 'Change in Total Daily Insulin Dose Values From Baseline to 12 Weeks of Treatment', 'timeFrame': 'Baseline and 12 weeks of each treatment', 'description': 'Insulin lispro low mix was to be administered within 15 minutes of morning and evening meals. Human insulin mix 30/70 was to be administered within 30 minutes of morning and evening meals. Change = Baseline - Endpoint'}, {'measure': 'Number of Participants Achieving Target Glycosylated Hemoglobin (HbA1c) Values <=7% and <=6.5%', 'timeFrame': '12 weeks of each treatment', 'description': 'Number of patients in each treatment group achieving the target HbA1c value during 12 weeks of each treatment.'}, {'measure': 'Number of Participants With Laboratory Parameters Significantly Different From Baseline', 'timeFrame': 'Baseline and 12 weeks of each treatment', 'description': 'Number of participants with laboratory parameters (hematology, chemistry, and urinalysis) that were significantly different from baseline after 12 weeks of each treatment.'}, {'measure': 'Hypoglycemia Rate Per Participant Per 30 Days', 'timeFrame': 'over 12 weeks of each treatment period', 'description': 'Hypoglycemia rate per patient per 30 days = (number of reported hypogylcemia events/number of days within the period) \\* 30 days. Since this was a 2x2 cross-over design (2 treatments and 2 periods), then the hypogyclemia rate was calculated per patient for each of the 2 periods by treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'type 1', 'type 2'], 'conditions': ['Diabetes Mellitus, Type 1', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare glycemic control (HbA1c) in Chinese patients with type 1 or type 2 diabetes when treated with insulin lispro low mixture and human insulin 30/70.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically diagnosed type 1or type 2 diabetes for at least 2 months\n* Aged between 18 and 70 (inclusive)\n* Have been treated with human insulin mix 30/70 twice daily for at least 2 months prior to entering the study\n* Have glycosylated hemoglobin (Hb1Ac) between 1.2 and 1.7 times the upper limit of normal reference range within 2 weeks prior to or at Visit 1\n* Compliance with diet and insulin therapy and performs regular blood glucose monitoring\n\nExclusion Criteria:\n\n* Have used oral antidiabetic agents within 30 days prior to entry into the study\n* Receive a total daily dose of insulin \\>2 units/kilogram\n* Have had more than two episodes of severe hypoglycemia within 6 months prior to entry into the study\n* Have a body mass index \\>35 kilograms per square meter (kg/m2)\n* Receive chronic systemic glucocorticoid therapy'}, 'identificationModule': {'nctId': 'NCT00420095', 'acronym': 'IOPA', 'briefTitle': 'A Study for Patients With Diabetes Mellitus (IOPA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Comparison of HbA1c in Type 1 or Type 2 Diabetic Patients Using Insulin Treated Twice Daily With Either Insulin Lispro Low Mixture or Human Insulin Mix 30/70', 'orgStudyIdInfo': {'id': '11423'}, 'secondaryIdInfos': [{'id': 'F3Z-GH-IOPA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Human insulin mix 30/70', 'interventionNames': ['Drug: Human insulin 30/70']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Insulin lispro low mix', 'interventionNames': ['Drug: Insulin lispro low mix']}], 'interventions': [{'name': 'Human insulin 30/70', 'type': 'DRUG', 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks', 'armGroupLabels': ['1']}, {'name': 'Insulin lispro low mix', 'type': 'DRUG', 'otherNames': ['LM', 'Low Mix', 'Humalog'], 'description': 'Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'country': 'China', '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': 23.11667, 'lon': 113.25}}, {'zip': '310003', 'city': 'Hangzhou', 'country': 'China', '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': 30.29365, 'lon': 120.16142}}, {'zip': '150086', 'city': 'Harbin', 'country': 'China', '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': 45.75, 'lon': 126.65}}, {'zip': '230022', 'city': 'Hefei', 'country': 'China', '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': 31.86389, 'lon': 117.28083}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM 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'}}}}