Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-02-27 @ 4:05 PM
Study NCT ID:
NCT02293551
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2014-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Lispro Formulations in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': '800-545-5979', 'title': 'Eli Lilly and Company', 'organization': 'Chief Medical Officer'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': '54 participants were randomly assigned to treatment, 54 participants received at least 1 dose of study drug, 24 participants completed all 5 periods of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: Lispro (7.0 U - Reference)', 'description': 'Reference formulation: Single dose of lispro administered SC in one of five periods.', 'otherNumAtRisk': 24, 'otherNumAffected': 4, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part A: Lispro (7.28 U - Test A)', 'description': 'Formulation A: Single dose of lispro administered SC in one of five periods.', 'otherNumAtRisk': 24, 'otherNumAffected': 4, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A: Lispro (7.28 U - Test B)', 'description': 'Formulation B: Single dose of lispro administered SC in one of five periods.', 'otherNumAtRisk': 24, 'otherNumAffected': 4, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part A: Lispro (7.28 U - Test C)', 'description': 'Formulation C: Single dose of lispro administered SC in one of five periods.', 'otherNumAtRisk': 24, 'otherNumAffected': 4, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part A: Lispro (7.28 U - Test D)', 'description': 'Formulation D: Single dose of lispro administered SC in one of five periods.', 'otherNumAtRisk': 24, 'otherNumAffected': 2, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part B: Lispro (7.28 U - Test B)', 'description': 'Formulation selected from Part B. Single dose of lispro administered SC in one of four periods.', 'otherNumAtRisk': 28, 'otherNumAffected': 6, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part B: Lispro (15.47 U - Test B)', 'description': 'Formulation selected from Part B. Single dose of lispro administered SC in one of four periods.', 'otherNumAtRisk': 28, 'otherNumAffected': 3, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part B: Lispro (30.03 U - Test B)', 'description': 'Formulation selected from Part B. Single dose of lispro administered SC in one of four periods.', 'otherNumAtRisk': 29, 'otherNumAffected': 7, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Catheter site related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part A and Part B: Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '28', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Lispro (7.0 U - Reference)', 'description': 'Reference formulation: Single dose of lispro administered SC in one of five periods.'}, {'id': 'OG001', 'title': 'Part A: Lispro (7.28 U - Test A)', 'description': 'Formulation A: Single dose of lispro administered SC in one of five periods.'}, {'id': 'OG002', 'title': 'Part A: Lispro (7.28 U - Test B)', 'description': 'Formulation B: Single dose of lispro administered SC in one of five periods.'}, {'id': 'OG003', 'title': 'Part A: Lispro (7.28 U - Test C)', 'description': 'Formulation C: Single dose of lispro administered SC in one of five periods.'}, {'id': 'OG004', 'title': 'Part A: Lispro (7.28 U - Test D)', 'description': 'Formulation D: Single dose of lispro administered SC in one of five periods.'}, {'id': 'OG005', 'title': 'Part B: Lispro (7.28 U - Test B)', 'description': 'Formulation selected from Part A. Single dose of lispro administered SC in one of four periods.'}, {'id': 'OG006', 'title': 'Part B: Lispro (15.47 U - Test B)', 'description': 'Formulation selected from Part A. Single dose of lispro administered SC in one of four periods.'}, {'id': 'OG007', 'title': 'Part B: Lispro (30.03 U - Test B)', 'description': 'Formulation selected from Part A. Single dose of lispro administered SC in one of four periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '916', 'spread': '21', 'groupId': 'OG000'}, {'value': '957', 'spread': '22', 'groupId': 'OG001'}, {'value': '1020', 'spread': '22', 'groupId': 'OG002'}, {'value': '972', 'spread': '21', 'groupId': 'OG003'}, {'value': '971', 'spread': '23', 'groupId': 'OG004'}, {'value': '864', 'spread': '17', 'groupId': 'OG005'}, {'value': '2000', 'spread': '20', 'groupId': 'OG006'}, {'value': '3990', 'spread': '14', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.2071', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Ratio of Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.04', 'ciLowerLimit': '0.988', 'ciUpperLimit': '1.10', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric Ratio of Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.11', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.17', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.'}, {'pValue': '0.0123', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric of Ratio Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.08', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.13', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.'}, {'pValue': '0.0331', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Ratio of Least Square Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.07', 'ciLowerLimit': '1.02', 'ciUpperLimit': '1.13', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.'}, {'groupIds': ['OG005', 'OG006', 'OG007'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.11', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.16', 'estimateComment': 'Dose proportionality and the degree of dose proportionality was assessed by fitting the power model versus dose. Estimated ratio of dose-normalized geometric means of PK parameters between the highest and lowest doses assessed dose proportionality.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-30, 0 (Predose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, and 300 Minutes', 'description': 'Primary outcome measure is based on the PK area under the concentration curve from 0 to infinity with a measurable concentration.', 'unitOfMeasure': 'picomole*hour/Liter (pmol*hr/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who were completers and had evaluable PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: Lispro Sequence 1', 'description': 'Each participant received a single subcutaneous (SC) dose of 7.0 U insulin lispro (Reference) and 4 doses of different test insulin lispro formulations (7.28 U; Tests A, B, C, and D) in one of five periods according to assigned treatment sequence 1, 2, or 3.\n\nSequence 1: Test A, D, C, Reference, B'}, {'id': 'FG001', 'title': 'Part A: Lispro Sequence 2', 'description': 'Each participant received a single SC dose of 7.0 U insulin lispro (Reference) and 4 doses of different test insulin lispro formulations (7.28 U; Tests A, B, C, and D) in one of five periods according to assigned treatment sequence 1, 2, or 3.\n\nSequence 2: Test B, A, Reference, C, D'}, {'id': 'FG002', 'title': 'Part A: Lispro Sequence 3', 'description': 'Each participant received a single SC dose of 7.0 U insulin lispro (Reference) and 4 doses of different test insulin lispro formulations (7.28 U; Tests A, B, C, and D) in one of five periods according to assigned treatment sequence 1, 2, or 3.\n\nSequence 3: Test Reference, Test C, B, D, A.'}, {'id': 'FG003', 'title': 'Part B: Lispro Sequence 1', 'description': 'Each participant received a single dose of lispro SC in one of four periods according to assigned treatment sequence 1, 2, or 3. Participants received test formulation B containing 7.28 U (Units) of insulin lispro given as a single SC injection or test formulation B containing 15.47 U of insulin lispro given as a single SC injection or test formulation B containing 30.03 U of insulin lispro given as a single SC injection.\n\nSequence 1: 30.03 U, 7.28 U, 15.47 U, 7.28 U'}, {'id': 'FG004', 'title': 'Part B Lispro Sequence 2', 'description': 'Each participant received a single dose of lispro SC in one of four periods according to assigned treatment sequence 1, 2, or 3. Participants received test formulation B containing 7.28 U (Units) of insulin lispro given as a single SC injection or test formulation B containing 15.47 U of insulin lispro given as a single SC injection or test formulation B containing 30.03 U of insulin lispro given as a single SC injection.\n\nSequence 2: 7.28 U, 15.47 U, 30.03 U, 15.47 U'}, {'id': 'FG005', 'title': 'Part B Lispro Sequence 3', 'description': 'Each participant received a single dose of lispro SC in one of four periods according to assigned treatment sequence 1, 2, or 3. Participants received test formulation B containing 7.28 U (Units) of insulin lispro given as a single SC injection or test formulation B containing 15.47 U of insulin lispro given as a single SC injection or test formulation B containing 30.03 U of insulin lispro given as a single SC injection.\n\nSequence 3: 15.47 U, 30.03 U, 7.28 U, 30.03 U'}], 'periods': [{'title': 'Part A and Part B Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'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': 'Part A and B Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'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': '1'}]}], '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': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}, {'title': 'Part A and B Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}, {'title': 'Part A and Part B Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}, {'title': 'Part A Period 5', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'comment': 'Part B had 4 periods', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Part B had 4 periods', 'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'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': 'Part A was a 5-period crossover study and Part B was a 4-period crossover study. A washout of 72 hours was observed between doses with a follow up within 7 to 14 days after the last dose.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A Participants', 'description': 'Each participant received a single SC dose of 7.0 U insulin lispro (Reference) and 4 doses of different test insulin lispro formulations (7.28 U; Tests A, B, C, and D) in one of five periods according to assigned treatment sequence 1, 2, or 3.\n\nSequence 1: Test A, D, C, Reference, B Sequence 2: Test B, A, Reference, C, D Sequence 3: Test Reference, Test C, B, D, A.'}, {'id': 'BG001', 'title': 'Part B Participants', 'description': 'Each participant received a single dose of lispro SC in one of four periods according to assigned treatment sequence 1, 2, or 3. Participants received test formulation B containing 7.28 U (Units) of insulin lispro given as a single SC injection or test formulation B containing 15.47 U of insulin lispro given as a single SC injection or test formulation B containing 30.03 U of insulin lispro given as a single SC injection.\n\nSequence 1: 30.03 U, 7.28 U, 15.47 U, 7.28 U Sequence 2: 7.28 U, 15.47 U, 30.03 U, 15.47 U Sequence 3: 15.47 U, 30.03 U, 7.28 U, 30.03 U'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '36.8', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '37.2', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Singapore', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2014-11-13', 'resultsFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2014-11-13', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-05', 'studyFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A and Part B: Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞])', 'timeFrame': '-30, 0 (Predose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, and 300 Minutes', 'description': 'Primary outcome measure is based on the PK area under the concentration curve from 0 to infinity with a measurable concentration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to determine:\n\n* Part A\n\n * How quickly your body absorbs, breaks down and gets rid of the different formulations of insulin lispro compared to insulin lispro alone formulation.\n * The safety of insulin lispro in different formulations and any side effects that might be associated with it.\n* Part B:\n\n * How much insulin lispro from different dose ranges is found in the bloodstream using a test insulin lispro formulation (selected from Part A).\n * The safety of insulin lispro in different formulations and any side effects that might be associated with it.\n\nParticipants may only enroll in one part. The study is expected to last up to 10 weeks for each part.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Overtly healthy males or females (non-childbearing potential and with absent cyclical hormonal changes), as determined by medical history and physical examination\n\nExclusion Criteria:\n\n\\- Have a fasting plasma glucose less than or equal to (≤) 4.0 millimole per liter (mmol/L) at screening'}, 'identificationModule': {'nctId': 'NCT02293551', 'briefTitle': 'A Study of Lispro Formulations in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Safety, Tolerability, and Pharmacokinetics of Multiple Novel Insulin Lispro Formulations', 'orgStudyIdInfo': {'id': '15626'}, 'secondaryIdInfos': [{'id': 'F3Z-FW-ITCA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Lispro (A)', 'description': 'Formulation A: Single dose of lispro administered subcutaneously (SC) in one of five periods.', 'interventionNames': ['Drug: Lispro']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Lispro (B)', 'description': 'Formulation B: Single dose of lispro administered SC in one of five periods.', 'interventionNames': ['Drug: Lispro']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Lispro (C)', 'description': 'Formulation C: Single dose of lispro administered SC in one of five periods.', 'interventionNames': ['Drug: Lispro']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Lispro (D)', 'description': 'Formulation D: Single dose of lispro administered SC in one of five periods.', 'interventionNames': ['Drug: Lispro']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: Lispro (Reference)', 'description': 'Reference formulation: Single dose of lispro administered SC in one of five periods.', 'interventionNames': ['Drug: Lispro']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Lispro', 'description': 'Formulation selected from Part A. Single dose of lispro administered SC in one of four periods.', 'interventionNames': ['Drug: Lispro']}], 'interventions': [{'name': 'Lispro', 'type': 'DRUG', 'otherNames': ['LY275585'], 'description': 'Administered SC', 'armGroupLabels': ['Part A: Lispro (A)', 'Part A: Lispro (B)', 'Part A: Lispro (C)', 'Part A: Lispro (D)', 'Part A: Lispro (Reference)', 'Part B: Lispro']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', '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': 1.28967, 'lon': 103.85007}}], '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'}}}}