Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT03449433
Status:
COMPLETED
Last Update Posted:
2020-04-30
First Post:
2018-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061268', 'term': 'Insulin Lispro'}, {'id': 'D061267', 'term': 'Insulin Aspart'}], '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': 'up to 6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'LY900014', 'description': 'T1DM participants received a single, subcutaneous (SC) dose of LY900014.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 0, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Insulin Lispro (Humalog®)', 'description': 'T1DM participants received a single, SC dose of insulin lispro (Humalog®).', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Insulin Aspart (Fiasp®)', 'description': 'T1DM participants received a single, SC dose of insulin aspart (Fiasp®).', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 0, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Insulin Aspart (NovoRapid®)', 'description': 'T1DM participants received a single, SC dose of insulin aspart (NovoRapid®).', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Healthy Participants', 'description': 'Healthy subject cohort, cohort did not receive any dose of study drug.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LY900014', 'description': 'T1DM participants received a single, individualized, subcutaneous (SC) dose of LY900014'}, {'id': 'OG001', 'title': 'Insulin Lispro (Humalog®)', 'description': 'T1DM participants received a single,individualized, SC dose of insulin lispro (Humalog)'}, {'id': 'OG002', 'title': 'Insulin Aspart (NovoRapid®)', 'description': 'T1DM participants received a single,individualized, SC dose of insulin'}, {'id': 'OG003', 'title': 'Insulin Aspart (Fiasp®)', 'description': 'T1DM participants received a single,individualized, SC dose of insulin aspart'}], 'classes': [{'categories': [{'measurements': [{'value': '786', 'spread': '36', 'groupId': 'OG000'}, {'value': '756', 'spread': '37', 'groupId': 'OG001'}, {'value': '938', 'spread': '41', 'groupId': 'OG002'}, {'value': '928', 'spread': '36', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.985', 'ciUpperLimit': '1.10', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdose', 'description': 'PK: Insulin Lispro or Insulin Aspart AUC(0-7h)', 'unitOfMeasure': 'picomols times hour per Liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, T1DM participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'LY900014', 'description': 'T1DM participants received a single, individualized, subcutaneous (SC) dose of LY900014'}, {'id': 'OG001', 'title': 'Insulin Lispro (Humalog®)', 'description': 'T1DM participants received a single,individualized, SC dose of insulin lispro (Humalog®) T1DM participants'}, {'id': 'OG002', 'title': 'Insulin Aspart (NovoRapid®)', 'description': 'T1DM participants received a single,individualized, SC dose of insulin aspart'}, {'id': 'OG003', 'title': 'Insulin Aspart (Fiasp®)', 'description': 'T1DM participants received a single,individualized, SC dose of insulin aspart'}, {'id': 'OG004', 'title': 'Healthy Participants', 'description': 'Healthy participants, cohort did not receive study drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.5', 'spread': '212', 'groupId': 'OG000'}, {'value': '141', 'spread': '224', 'groupId': 'OG001'}, {'value': '157', 'spread': '243', 'groupId': 'OG002'}, {'value': '101', 'spread': '226', 'groupId': 'OG003'}, {'value': '44.1', 'spread': '32.5', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time Frame:-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes postdose', 'description': 'PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)', 'unitOfMeasure': 'milligrams times hour per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who evaluable PD parameters.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Type 1 Diabetes Mellitus (T1DM) Cohort 1', 'description': 'Period 1: LY900014 administered subcutaneously (SC) immediately before meal Period 2: insulin n Aspart (Fiasp®) administered SC Period 3:Insulin Lispro (Humalog®) administered SC Period 4: Insulin Aspart (NovoRapid®) administered SC\n\nwith 21 hours between doses'}, {'id': 'FG001', 'title': 'T1DM Cohort 2', 'description': 'Period 1: Insulin Aspart (Fiasp®) administered SC Period 2: LY900014 administered subcutaneously (SC) Period 3: Insulin Aspart (NovoRapid®) administered SC Period 4:Insulin Lispro (Humalog®) administered SC\n\nwith 21 hours between doses'}, {'id': 'FG002', 'title': 'T1DM Cohort 3', 'description': 'Period 1: Insulin Aspart (NovoRapid®) administered SC Period 2:Insulin Lispro (Humalog®) administered SC Period 3: insulin Aspart (Fiasp®) administered SC Period 4: LY900014 administered subcutaneously (SC)\n\nwith 21 hours between doses'}, {'id': 'FG003', 'title': 'T1DM Cohort 4', 'description': 'Period 1:Insulin Lispro (Humalog®) administered SC Period 2: Insulin Aspart (NovoRapid®) administered SC Period 3: LY900014 administered SC Period 4: insulin Aspart (Fiasp®) administered SC\n\nwith 21 hours between doses'}, {'id': 'FG004', 'title': 'Healthy Participants', 'description': 'Healthy participant cohort did not receive any dose of study drug.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'T1DM Cohort', 'description': 'All randomized participants with T1DM participants who received at least 1 dose of study drug.'}, {'id': 'BG001', 'title': 'Healthy Participants', 'description': 'All healthy participants.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '68', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '80', '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', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '25.82', 'spread': '2.36', 'groupId': 'BG000'}, {'value': '25.38', 'spread': '1.80', 'groupId': 'BG001'}, {'value': '25.38', 'spread': '1.80', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms per meter squared', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants that received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-10', 'size': 3995440, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-06-25T13:04', 'hasProtocol': True}, {'date': '2018-03-08', 'size': 522276, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-06-25T13:10', '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': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-20', 'studyFirstSubmitDate': '2018-02-23', 'resultsFirstSubmitDate': '2020-04-20', 'studyFirstSubmitQcDate': '2018-02-23', 'lastUpdatePostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-20', 'studyFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm', 'timeFrame': '0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdose', 'description': 'PK: Insulin Lispro or Insulin Aspart AUC(0-7h)'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)', 'timeFrame': 'Time Frame:-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes postdose', 'description': 'PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'Two forms of insulin lispro (LY900014 and Humalog®) and two forms of insulin aspart (NovoRapid® and Fiasp®) will be given to trial participants with diabetes mellitus type 1 by injection under the skin. The study will assess how fast the active ingredient (insulin lispro or insulin aspart) gets into the blood stream and how long it takes the body to remove it. A test meal will be given to trial participants to assess the course of the blood sugar lowering effect of the investigational products. The safety and tolerability of LY900014 will also be assessed. Screening is required within 14 days prior to the lead in. For each participant, the study will last up to 91 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1 year\n* Have a body mass index (BMI) of 18.5 to 35.0 kilogram per meter square (kg/m²)\n* Have a glycated hemoglobin (HbA1c) less than (\\<)9.0 percent (%)\n* Have had no episodes of severe hypoglycaemia in the last 6 months\n\nExclusion Criteria:\n\n\\- Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data'}, 'identificationModule': {'nctId': 'NCT03449433', 'briefTitle': 'A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Mixed Meal Tolerance Test Study to Evaluate the Pharmacokinetics and Pharmacodynamics of LY900014 Compared to Humalog Following a Single Dose in Adults With Type 1 Diabetes', 'orgStudyIdInfo': {'id': '16911'}, 'secondaryIdInfos': [{'id': 'I8B-MC-ITSL', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2017-003459-47', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY900014', 'description': 'T1DM participants received a single, individualized, subcutaneous (SC) dose of LY900014.', 'interventionNames': ['Drug: LY900014']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Lispro (Humalog®)', 'description': 'T1DM participants received a single, individualized, SC dose of insulin lispro.', 'interventionNames': ['Drug: Insulin Lispro']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Aspart (NovoRapid®)', 'description': 'T1DM participants received a single, individualized, SC dose of insulin aspart.', 'interventionNames': ['Drug: Insulin Aspart']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin Aspart (Fiasp®)', 'description': 'T1DM participants received a single, individualized, SC dose of insulin aspart.', 'interventionNames': ['Drug: Insulin Aspart']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy Participants', 'description': 'Healthy participants who received no study drug.'}], 'interventions': [{'name': 'LY900014', 'type': 'DRUG', 'otherNames': ['Ultra-Rapid Lispro'], 'description': 'Administered SC', 'armGroupLabels': ['LY900014']}, {'name': 'Insulin Lispro', 'type': 'DRUG', 'otherNames': ['Humalog®', 'LY275585'], 'description': 'Administered SC', 'armGroupLabels': ['Insulin Lispro (Humalog®)']}, {'name': 'Insulin Aspart', 'type': 'DRUG', 'otherNames': ['NovoRapid®'], 'description': 'Administered SC', 'armGroupLabels': ['Insulin Aspart (NovoRapid®)']}, {'name': 'Insulin Aspart', 'type': 'DRUG', 'otherNames': ['Fiasp®'], 'description': 'Administered SC', 'armGroupLabels': ['Insulin Aspart (Fiasp®)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41460', 'city': 'Neuss', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Profil Institut für Stoffwechselforschung', '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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}