Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-01 @ 7:19 AM
Study NCT ID:
NCT01133392
Status:
COMPLETED
Last Update Posted:
2014-12-30
First Post:
2010-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence of Two Lispro Formulations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic 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': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': '38 participants were randomly assigned to treatment, 38 participants received at least 1 dose of study drug, 36 participants completed all 4 periods of the study. One participant only completed 1 insulin lispro B period and then discontinued. This participant did not complete the insulin lispro A periods.', 'eventGroups': [{'id': 'EG000', 'title': 'Insulin Lispro A', 'description': 'Insulin lispro A formulation (Treatment A, test - 2 occasions)', 'otherNumAtRisk': 37, 'otherNumAffected': 9, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Insulin Lispro B', 'description': 'Insulin lispro B formulation (Treatment B, reference - 2 occasions)', 'otherNumAtRisk': 38, 'otherNumAffected': 12, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eye discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Catheter site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Catheter site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Procedural site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Lispro A', 'description': '20 units (U) administered subcutaneously (SC)'}, {'id': 'OG001', 'title': 'Insulin Lispro B', 'description': '20 units (U) administered subcutaneously (SC)'}], 'classes': [{'categories': [{'measurements': [{'value': '1920', 'spread': '20', 'groupId': 'OG000'}, {'value': '1940', 'spread': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.990', 'ciLowerLimit': '0.948', 'ciUpperLimit': '1.034', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 up to 8 hours post dose', 'description': 'Primary outcome measure is based on the pharmacokinetic area under the concentration-time curve from time 0 to the last time point with a measurable concentration.', 'unitOfMeasure': 'picomole*hour/liter (pmol*h/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Lispro A', 'description': '20 units (U) administered subcutaneously (SC)'}, {'id': 'OG001', 'title': 'Insulin Lispro B', 'description': '20 units (U) administered subcutaneously (SC)'}], 'classes': [{'categories': [{'measurements': [{'value': '819', 'spread': '32', 'groupId': 'OG000'}, {'value': '887', 'spread': '34', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.933', 'ciLowerLimit': '0.897', 'ciUpperLimit': '0.972', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 to 8 hours post dose', 'description': 'The maximum observed insulin lispro concentration following dosing.', 'unitOfMeasure': 'picomole/liter (pmol/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had at least one study treatment and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Lispro A', 'description': '20 units (U) administered subcutaneously (SC)'}, {'id': 'OG001', 'title': 'Insulin Lispro B', 'description': '20 units (U) administered subcutaneously (SC)'}], 'classes': [{'categories': [{'measurements': [{'value': '544', 'spread': '23', 'groupId': 'OG000'}, {'value': '539', 'spread': '27', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.005', 'ciLowerLimit': '0.958', 'ciUpperLimit': '1.054', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 to 8 hours post dose', 'description': 'The maximum observed glucose infusion rate during the euglycemic clamp procedure.', 'unitOfMeasure': 'milligrams per minute (mg/min)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had at least one study treatment and had evaluable pharmacodynamic (PD) data.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Lispro A', 'description': '20 units (U) administered subcutaneously (SC)'}, {'id': 'OG001', 'title': 'Insulin Lispro B', 'description': '20 units (U) administered subcutaneously (SC)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.11', 'spread': '49', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '56', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.100', 'ciLowerLimit': '-0.400', 'ciUpperLimit': '0.500', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 to 8 hours post dose', 'description': 'Time of maximal glucose infusion rate.', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had at least one study treatment and had evaluable PD data.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Lispro A', 'description': '20 units (U) administered subcutaneously (SC)'}, {'id': 'OG001', 'title': 'Insulin Lispro B', 'description': '20 units (U) administered subcutaneously (SC)'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'spread': '25', 'groupId': 'OG000'}, {'value': '123', 'spread': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.014', 'ciLowerLimit': '0.961', 'ciUpperLimit': '1.070', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 to 8 hours post dose', 'description': 'The total amount of glucose infused during the euglycemic clamp procedure.', 'unitOfMeasure': 'grams (g)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who had at least one study treatment and had evaluable PD data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Lispro Dosing Sequence ABAB', 'description': 'Each participant was administered insulin lispro A formulation (Treatment A, test - 2 occasions) and insulin lispro B formulation (Treatment B, reference - 2 occasions) in the dosing sequence ABAB. There was an interval of approximately 4 to 7 days between doses.'}, {'id': 'FG001', 'title': 'Insulin Lispro Dosing Sequence BABA', 'description': 'Each participant was administered insulin lispro A formulation (Treatment A, test - 2 occasions) and insulin lispro B formulation (Treatment B, reference - 2 occasions) in the dosing sequence BABA. There was an interval of approximately 4 to 7 days between doses.'}], 'periods': [{'title': 'First Intervention (1 Day )', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Interval Between Dosing (4-7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Interval Between Dosing (4-7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Interval Between Dosing (4-7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Fourth Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '41 participants were enrolled into the study. 3 participants discontinued due to subject decision prior to receiving treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Lispro Dosing Sequence ABAB', 'description': 'Each participant was administered insulin lispro A formulation (Treatment A, test - 2 occasions) and insulin lispro B formulation (Treatment B, reference - 2 occasions) in the dosing sequence ABAB.'}, {'id': 'BG001', 'title': 'Insulin Lispro Dosing Sequence BABA', 'description': 'Each participant was administered insulin lispro A formulation (Treatment A, test - 2 occasions) and insulin lispro B formulation (Treatment B, reference - 2 occasions) in the dosing sequence BABA.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.4', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '34.6', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '32.4', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Singapore', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-29', 'studyFirstSubmitDate': '2010-05-27', 'resultsFirstSubmitDate': '2014-10-10', 'studyFirstSubmitQcDate': '2010-05-27', 'lastUpdatePostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-29', 'studyFirstPostDateStruct': {'date': '2010-05-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast]', 'timeFrame': '0 up to 8 hours post dose', 'description': 'Primary outcome measure is based on the pharmacokinetic area under the concentration-time curve from time 0 to the last time point with a measurable concentration.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax]', 'timeFrame': '0 to 8 hours post dose', 'description': 'The maximum observed insulin lispro concentration following dosing.'}, {'measure': 'Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)', 'timeFrame': '0 to 8 hours post dose', 'description': 'The maximum observed glucose infusion rate during the euglycemic clamp procedure.'}, {'measure': 'Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)', 'timeFrame': '0 to 8 hours post dose', 'description': 'Time of maximal glucose infusion rate.'}, {'measure': 'Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)', 'timeFrame': '0 to 8 hours post dose', 'description': 'The total amount of glucose infused during the euglycemic clamp procedure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insulin', 'lispro'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.', 'detailedDescription': 'The 2 formulations of insulin lispro will be referred to here as:\n\nLispro A\n\nLispro B'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are healthy males or females.\n* Body mass index (BMI) between 18.5 and 29.9 kilograms per meter squared (kg/m\\^2)\n* Are nonsmokers.\n* Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range at screening.\n\nExclusion Criteria:\n\n* History of first-degree relatives known to have diabetes mellitus.\n* Evidence of significant active neuropsychiatric disease.\n* Evidence of an acute infection with fever or infectious disease.\n* Intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).\n* Have used systemic glucocorticoids within 3 months prior to entry into the study.\n* Have donated blood of 1 unit or more within the last 3 months prior to study entry.\n* Excessive alcohol intake\n* Have a fasting venous blood glucose (FBG, plasma) \\>6 millimoles/liter (mmol/L) at screening.\n* Have positive hepatitis B surface antigen.'}, 'identificationModule': {'nctId': 'NCT01133392', 'briefTitle': 'Bioequivalence of Two Lispro Formulations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Evaluation of the Bioequivalence of Two Formulations of Insulin Lispro in Healthy Subjects', 'orgStudyIdInfo': {'id': '13300'}, 'secondaryIdInfos': [{'id': 'F3Z-EW-IOPY', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin Lispro A', 'description': '20 units (U) subcutaneously (SC)', 'interventionNames': ['Drug: Insulin lispro A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin lispro B', 'description': '20 units (U) subcutaneously (SC)', 'interventionNames': ['Drug: Insulin lispro B']}], 'interventions': [{'name': 'Insulin lispro A', 'type': 'DRUG', 'otherNames': ['LY275585'], 'description': '20 units (U) subcutaneously (SC).', 'armGroupLabels': ['Insulin Lispro A']}, {'name': 'Insulin lispro B', 'type': 'DRUG', 'otherNames': ['LY275585'], 'description': '20 U subcutaneously (SC).', 'armGroupLabels': ['Insulin lispro B']}]}, '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 from 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'}}}}