Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-06-13 @ 7:55 PM
Study NCT ID:
NCT03286751
Status:
COMPLETED
Last Update Posted:
2020-05-01
First Post:
2017-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': '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': {'email': 'Clinicaltrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to study completion (up to 12 weeks)', 'eventGroups': [{'id': 'EG000', 'title': '7 U LY900014', 'description': 'Single SC dose 7 U LY900014.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 7, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '15 U LY900014', 'description': 'Single SC dose 15 U LY900014.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 5, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '30 U LY900014', 'description': 'Single SC dose 30 U LY900014.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 14, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '7 U Humalog', 'description': 'Single SC dose 7 U Humalog.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 8, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '15 U Humalog', 'description': 'Single SC dose 15 U Humalog.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 6, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '30 U Humalog', 'description': 'Single SC dose 15 U Humalog.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 5, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '7 U Humalog', 'description': 'Single SC dose 7 U Humalog.'}, {'id': 'OG001', 'title': '7 U LY900014', 'description': 'Single SC dose 7 U LY900014.'}, {'id': 'OG002', 'title': '15 U Humalog', 'description': 'Single SC dose 15 U Humalog.'}, {'id': 'OG003', 'title': '15 U LY900014', 'description': 'Single SC dose 15 U LY900014.'}, {'id': 'OG004', 'title': '30 U Humalog', 'description': 'Single SC dose 30 U Humalog.'}, {'id': 'OG005', 'title': '30 U LY900014', 'description': 'Single SC dose 30 U LY900014.'}], 'classes': [{'categories': [{'measurements': [{'value': '649', 'spread': '16', 'groupId': 'OG000'}, {'value': '656', 'spread': '17', 'groupId': 'OG001'}, {'value': '1400', 'spread': '19', 'groupId': 'OG002'}, {'value': '1450', 'spread': '17', 'groupId': 'OG003'}, {'value': '3050', 'spread': '18', 'groupId': 'OG004'}, {'value': '3180', 'spread': '20', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.5495', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric LSMeans', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.974', 'ciUpperLimit': '1.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2236', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of Geometric LSMeans', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.986', 'ciUpperLimit': '1.06', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0727', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Ratio of Geometric LSMeans', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.997', 'ciUpperLimit': '1.07', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose', 'description': 'Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose \\[AUC(0-10h)\\]', 'unitOfMeasure': 'picomole * hour per liter(pmol*/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Glucodynamics: Total Amount of Glucose Infused (Gtot)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '7 U Humalog', 'description': 'Single SC dose 7 U Humalog.'}, {'id': 'OG001', 'title': '7 U LY900014', 'description': 'Single SC dose 7 U LY900014.'}, {'id': 'OG002', 'title': '15 U Humalog', 'description': 'Single SC dose 15 U Humalog.'}, {'id': 'OG003', 'title': '15 U LY900014', 'description': 'Single SC dose 15 U LY900014.'}, {'id': 'OG004', 'title': '30 U Humalog', 'description': 'Single SC dose 30 U Humalog.'}, {'id': 'OG005', 'title': '30 U LY900014', 'description': 'Single SC dose 30 U LY900014.'}], 'classes': [{'categories': [{'measurements': [{'value': '1120', 'spread': '53', 'groupId': 'OG000'}, {'value': '1080', 'spread': '60', 'groupId': 'OG001'}, {'value': '1970', 'spread': '44', 'groupId': 'OG002'}, {'value': '1860', 'spread': '45', 'groupId': 'OG003'}, {'value': '3290', 'spread': '32', 'groupId': 'OG004'}, {'value': '3030', 'spread': '36', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.5749', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric LSMeans', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.08', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1578', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of Geometric LSMeans', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.03', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1351', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Ratio of Geometric LSMeans', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.03', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose', 'description': 'Glucodynamics: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp', 'unitOfMeasure': 'milligrams per kilogram (mg/kg)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and completed at least one clamp procedure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1: ABFCED', 'description': 'Participants received a single SC dose in each treatment period.\n\nA = 7 U LY900014\n\nB = 15 U LY900014\n\nF = 30 U Humalog\n\nC = 30 U LY900014\n\nE = 15 U Humalog\n\nD = 7 U Humalog'}, {'id': 'FG001', 'title': 'Sequence 2: BCADFE', 'description': 'Participants received a single SC dose in each treatment period.\n\nB = 15 U LY900014\n\nC = 30 U LY900014\n\nA = 7 U LY900014\n\nD = 7 U Humalog\n\nF = 30 U Humalog\n\nE = 15 U Humalog'}, {'id': 'FG002', 'title': 'Sequence 3: CDBEAF', 'description': 'Participants received a single SC dose in each treatment period.\n\nC = 30 U LY900014\n\nD = 7 U Humalog\n\nB = 15 U LY900014\n\nE = 15 U Humalog\n\nA = 7 U LY900014\n\nF = 30 U Humalog'}, {'id': 'FG003', 'title': 'Sequence 4: DECFBA', 'description': 'Participants received a single SC dose in each treatment period.\n\nD = 7 U Humalog\n\nE = 15 U Humalog\n\nC = 30 U LY900014\n\nF = 30 U Humalog\n\nB = 15 U LY900014\n\nA = 7 U LY900014'}, {'id': 'FG004', 'title': 'Sequence 5: EFDACB', 'description': 'Participants received a single SC dose in each treatment period.\n\nE = 15 U Humalog\n\nF = 30 U Humalog\n\nD = 7 U Humalog\n\nA = 7 U LY900014\n\nC = 30 U LY900014\n\nB = 15 U LY900014'}, {'id': 'FG005', 'title': 'Sequence 6: FAEBDC', 'description': 'Participants received a single SC dose in each treatment period.\n\nF = 30 U Humalog\n\nA = 7 U LY900014\n\nE = 15 U Humalog\n\nB = 15 U LY900014\n\nD = 7 U Humalog\n\nC = 30 U LY900014'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 5', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 5', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 6', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This was a 6-period crossover study in which participants received a single 7 Unit (U), 15 U, or 30 U subcutaneous (SC) dose of LY900014 or Humalog in one of six sequences. There was a washout period of ≥ 3 days between each euglycemic clamp procedure.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'All participants who received at least on dose of study drug.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.9', 'spread': '11.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All Participants who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-26', 'size': 1850022, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-01-16T14:29', 'hasProtocol': True}, {'date': '2018-04-18', 'size': 2177900, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-01-16T14:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-20', 'studyFirstSubmitDate': '2017-09-15', 'resultsFirstSubmitDate': '2020-04-20', 'studyFirstSubmitQcDate': '2017-09-15', 'lastUpdatePostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-20', 'studyFirstPostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC)', 'timeFrame': 'Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose', 'description': 'Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose \\[AUC(0-10h)\\]'}], 'secondaryOutcomes': [{'measure': 'Glucodynamics: Total Amount of Glucose Infused (Gtot)', 'timeFrame': 'Day 1: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose', 'description': 'Glucodynamics: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '34041713', 'type': 'DERIVED', 'citation': 'Leohr J, Dellva MA, Carter K, LaBell E, Linnebjerg H. Ultra Rapid Lispro (URLi) Accelerates Insulin Lispro Absorption and Insulin Action vs Humalog(R) Consistently Across Study Populations: A Pooled Analysis of Pharmacokinetic and Glucodynamic Data. Clin Pharmacokinet. 2021 Nov;60(11):1423-1434. doi: 10.1007/s40262-021-01030-0. Epub 2021 May 27.'}, {'pmid': '32900535', 'type': 'DERIVED', 'citation': 'Leohr J, Dellva MA, LaBell E, Coutant DE, Klein O, Plum-Moerschel L, Zijlstra E, Linnebjerg H. Pharmacokinetic and Glucodynamic Responses of Ultra Rapid Lispro vs Lispro Across a Clinically Relevant Range of Subcutaneous Doses in Healthy Subjects. Clin Ther. 2020 Sep;42(9):1762-1777.e4. doi: 10.1016/j.clinthera.2020.07.005. Epub 2020 Sep 6.'}]}, 'descriptionModule': {'briefSummary': 'This study compares LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs are given by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels in comparison with insulin lispro. The study will last about 7 to 12 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)\n* Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²)\n* Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results\n* Are nonsmokers, have not smoked for at least 6 months prior to entering the study\n\nExclusion Criteria:\n\n* Are currently participating in or completed a clinical trial within the last 30 days\n* Have previously participated or withdrawn from this study\n* Have donated blood or have blood loss of more than 500 mL within the past 3 months'}, 'identificationModule': {'nctId': 'NCT03286751', 'briefTitle': 'A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 and Humalog Across Different Subcutaneous Doses in Healthy Subjects', 'orgStudyIdInfo': {'id': '16898'}, 'secondaryIdInfos': [{'id': '2017-001859-32', 'type': 'EUDRACT_NUMBER'}, {'id': 'I8B-MC-ITSH', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY900014', 'description': 'Single dose of 7 units (U), 15 U, and 30 U of LY900014 administered subcutaneously (SC) in three of six periods.', 'interventionNames': ['Drug: LY900014']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Lispro (Humalog)', 'description': 'Single dose of 7 U, 15 U, and 30 U of insulin lispro administered SC in three of six periods.', 'interventionNames': ['Drug: Insulin Lispro']}], 'interventions': [{'name': 'LY900014', 'type': 'DRUG', 'otherNames': ['Ultra-Rapid Lispro'], 'description': 'Administered SC', 'armGroupLabels': ['LY900014']}, {'name': 'Insulin Lispro', 'type': 'DRUG', 'otherNames': ['LY275585', 'Humalog'], 'description': 'Administered SC', 'armGroupLabels': ['Insulin Lispro (Humalog)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55116', 'city': 'Mainz', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], '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': {'type': 'SPONSOR'}}}}