Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-07 @ 5:16 AM
Study NCT ID:
NCT01526733
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2012-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase
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': 'C005703', 'term': 'salicylhydroxamic acid'}, {'id': 'D061267', 'term': 'Insulin Aspart'}, {'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': '858-794-8889', 'title': 'Vice President, Endocrinology Clinical Development', 'organization': 'Halozyme Therapeutics, Inc'}, 'certainAgreement': {'otherDetails': 'All information obtained as a result of this study or during the conduct of this study will be regarded as confidential. The Investigator agrees to use the information for the purpose of carrying out this study and for no other purpose, unless prior written permission from the Sponsor (Halozyme) is obtained.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Insulin was not considered a study drug for safety assessments and causality assessments were done for rHuPH20 only.', 'eventGroups': [{'id': 'EG000', 'title': 'Insulin (Aspart or Lispro)-rHuPH20', 'description': 'In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.\n\nEach Phase was separated by a washout period of 5 to 21 days.', 'otherNumAtRisk': 24, 'otherNumAffected': 13, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Insulin (Aspart or Lispro)-Sham', 'description': 'In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.\n\nEach Phase was separated by a washout period of 5 to 21 days.', 'otherNumAtRisk': 23, 'otherNumAffected': 9, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Injection site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Early Insulin Exposure (%AUC[0-60])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin (Aspart or Lispro)-rHuPH20', 'description': 'In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.\n\nEach Phase was separated by a washout period of 5 to 21 days.'}, {'id': 'OG001', 'title': 'Insulin (Aspart or Lispro)-Sham', 'description': 'In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.\n\nEach Phase was separated by a washout period of 5 to 21 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '33.53', 'spread': '11.81', 'groupId': 'OG000'}, {'value': '17.85', 'spread': '8.24', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '39.45', 'spread': '9.72', 'groupId': 'OG000'}, {'value': '33.52', 'spread': '10.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.15', 'ciLowerLimit': '1.71', 'ciUpperLimit': '2.71', 'pValueComment': 'Comparison of Day 1 Insulin (Aspart or Lispro)-rHuPH20 versus Day 1 Insulin-sham.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.62', 'ciLowerLimit': '2.08', 'ciUpperLimit': '3.29', 'pValueComment': 'Comparison of Day 4 Insulin (Aspart or Lispro)-rHuPH20 versus Day 1 Insulin-sham.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.'}], 'paramType': 'MEAN', 'timeFrame': '10 minutes predose; 0, 5, 10, 15, 20, 30, 45, and 60 minutes postdose on Days 1 and 4', 'description': 'Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve \\[AUC{0 360}\\]) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, and 60 minutes postdose during a euglycemic clamp.', 'unitOfMeasure': 'percentage of AUC(0-60)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both phases of the study and with evaluable %AUC(0-60) data.'}, {'type': 'SECONDARY', 'title': 'Maximum Glucose Infusion Rate (GIRmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin (Aspart or Lispro)-rHuPH20', 'description': 'In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.\n\nEach Phase was separated by a washout period of 5 to 21 days.'}, {'id': 'OG001', 'title': 'Insulin (Aspart or Lispro)-Sham', 'description': 'In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.\n\nEach Phase was separated by a washout period of 5 to 21 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '13.47', 'spread': '5.46', 'groupId': 'OG000'}, {'value': '11.14', 'spread': '4.21', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '10.75', 'spread': '3.73', 'groupId': 'OG000'}, {'value': '11.83', 'spread': '3.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4', 'description': 'Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.', 'unitOfMeasure': 'milligrams/kilogram/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both phases of the study and with evaluable GIRmax data.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin (Aspart or Lispro)-rHuPH20', 'description': 'In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.\n\nEach Phase was separated by a washout period of 5 to 21 days.'}, {'id': 'OG001', 'title': 'Insulin (Aspart or Lispro)-Sham', 'description': 'In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.\n\nEach Phase was separated by a washout period of 5 to 21 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '78.95', 'spread': '37.16', 'groupId': 'OG000'}, {'value': '132.62', 'spread': '55.07', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '81.86', 'spread': '45.99', 'groupId': 'OG000'}, {'value': '97.38', 'spread': '47.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4', 'description': 'Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both phases of the study and with evaluable tGIRmax data.'}, {'type': 'SECONDARY', 'title': 'Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin (Aspart or Lispro)-rHuPH20', 'description': 'In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.\n\nEach Phase was separated by a washout period of 5 to 21 days.'}, {'id': 'OG001', 'title': 'Insulin (Aspart or Lispro)-Sham', 'description': 'In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.\n\nEach Phase was separated by a washout period of 5 to 21 days.'}], 'classes': [{'title': 'Early tGIR50%, Day 1', 'categories': [{'measurements': [{'value': '40.33', 'spread': '20.13', 'groupId': 'OG000'}, {'value': '54.67', 'spread': '33.97', 'groupId': 'OG001'}]}]}, {'title': 'Late tGIR50%, Day 1', 'categories': [{'measurements': [{'value': '114.52', 'spread': '54.33', 'groupId': 'OG000'}, {'value': '152.14', 'spread': '61.00', 'groupId': 'OG001'}]}]}, {'title': 'Early tGIR50%, Day 4', 'categories': [{'measurements': [{'value': '32.57', 'spread': '14.50', 'groupId': 'OG000'}, {'value': '39.67', 'spread': '15.51', 'groupId': 'OG001'}]}]}, {'title': 'Late tGIR50%, Day 4', 'categories': [{'measurements': [{'value': '113.24', 'spread': '48.72', 'groupId': 'OG000'}, {'value': '126.71', 'spread': '50.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4', 'description': 'Early and late tGIR50%max are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both phases of the study and with evaluable early and late tGIR50%max data.'}, {'type': 'SECONDARY', 'title': 'Time to 50% Total Glucose Infused (50%Gtot)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin (Aspart or Lispro)-rHuPH20', 'description': 'In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) rHuPH20.\n\nEach Phase was separated by a washout period of 5 to 21 days.'}, {'id': 'OG001', 'title': 'Insulin (Aspart or Lispro)-Sham', 'description': 'In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.\n\nEach Phase was separated by a washout period of 5 to 21 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '40.33', 'spread': '20.13', 'groupId': 'OG000'}, {'value': '32.57', 'spread': '14.50', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '54.67', 'spread': '54.67', 'groupId': 'OG000'}, {'value': '39.67', 'spread': '15.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4', 'description': 'Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both phases of the study and with evaluable 50%Gtot data.'}, {'type': 'SECONDARY', 'title': 'Area Under the Glucose Concentration Curve (AUC[0-360])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin (Aspart or Lispro)-rHuPH20', 'description': 'In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.\n\nEach Phase was separated by a washout period of 5 to 21 days.'}, {'id': 'OG001', 'title': 'Insulin (Aspart or Lispro)-Sham', 'description': 'In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.\n\nEach Phase was separated by a washout period of 5 to 21 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '1312.41', 'spread': '627.33', 'groupId': 'OG000'}, {'value': '1199.54', 'spread': '535.80', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '1063.77', 'spread': '500.06', 'groupId': 'OG000'}, {'value': '1139.65', 'spread': '414.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes and 10 minutes predose; 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4', 'description': 'Area under the glucose concentration curve from 0 to 360 minutes (AUC\\[0-360\\]) is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.', 'unitOfMeasure': 'picomoles*minutes/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both phases of the study and with evaluable AUC(0-360) data.'}, {'type': 'SECONDARY', 'title': 'Duration of Insulin Action (AUMC[0-360]/AUC[0-360])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin (Aspart or Lispro)-rHuPH20', 'description': 'In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.\n\nEach Phase was separated by a washout period of 5 to 21 days.'}, {'id': 'OG001', 'title': 'Insulin (Aspart or Lispro)-Sham', 'description': 'In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.\n\nEach Phase was separated by a washout period of 5 to 21 days.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '119.02', 'spread': '21.18', 'groupId': 'OG000'}, {'value': '154.03', 'spread': '27.58', 'groupId': 'OG001'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '111.25', 'spread': '20.59', 'groupId': 'OG000'}, {'value': '120.57', 'spread': '20.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes predose; 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4', 'description': 'Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC\\[0-360\\]) by the area under the concentration versus time curve (AUC\\[0-360\\]). AUCM is the total area under the first moment curve. First moment curve is obtained by plotting concentration-time versus time. It can be used to measure how long a drug stays in the body. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both phases of the study and with evaluable AUMC(0-360)/AUC(0-360) data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin-rHuPH20, Then Insulin-sham', 'description': 'In Phase I, participants received 0.15 units per kilogram (U/kg) insulin (either insulin aspart or insulin lispro) as a continuous subcutaneous insulin infusion (CSII) for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 milliliter (mL) (150 U) injection of recombinant human hyaluronidase PH20 (rHuPH20).\n\nIn Phase II, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with a sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.\n\nPhase I and II were separated by a washout period of 5 to 21 days.'}, {'id': 'FG001', 'title': 'Insulin-sham, Then Insulin-rHuPH20', 'description': 'In Phase I, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with a sham injection administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.\n\nIn Phase II, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.\n\nPhase I and Phase II were separated by a washout period of 5 to 21 days.'}], 'periods': [{'title': 'Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'comment': 'One participant discontinued after receiving insulin-sham and before receiving insulin-rHuPH20.', 'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Washout Period of 5 to 21 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Phase 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Enrolled Participants', 'description': 'All participants enrolled in the study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.6', 'spread': '9.13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '23', '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', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All enrolled participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-05', 'studyFirstSubmitDate': '2012-01-31', 'resultsFirstSubmitDate': '2014-09-23', 'studyFirstSubmitQcDate': '2012-02-03', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-09-23', 'studyFirstPostDateStruct': {'date': '2012-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early Insulin Exposure (%AUC[0-60])', 'timeFrame': '10 minutes predose; 0, 5, 10, 15, 20, 30, 45, and 60 minutes postdose on Days 1 and 4', 'description': 'Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve \\[AUC{0 360}\\]) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, and 60 minutes postdose during a euglycemic clamp.'}], 'secondaryOutcomes': [{'measure': 'Maximum Glucose Infusion Rate (GIRmax)', 'timeFrame': '0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4', 'description': 'Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.'}, {'measure': 'Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax)', 'timeFrame': '0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4', 'description': 'Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.'}, {'measure': 'Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max)', 'timeFrame': '0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4', 'description': 'Early and late tGIR50%max are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.'}, {'measure': 'Time to 50% Total Glucose Infused (50%Gtot)', 'timeFrame': '0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4', 'description': 'Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.'}, {'measure': 'Area Under the Glucose Concentration Curve (AUC[0-360])', 'timeFrame': '30 minutes and 10 minutes predose; 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4', 'description': 'Area under the glucose concentration curve from 0 to 360 minutes (AUC\\[0-360\\]) is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.'}, {'measure': 'Duration of Insulin Action (AUMC[0-360]/AUC[0-360])', 'timeFrame': '10 minutes predose; 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4', 'description': 'Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC\\[0-360\\]) by the area under the concentration versus time curve (AUC\\[0-360\\]). AUCM is the total area under the first moment curve. First moment curve is obtained by plotting concentration-time versus time. It can be used to measure how long a drug stays in the body. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 1 Diabetes', 'Continuous Subcutaneous Insulin Infusion (CSII)'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.halozyme.com', 'label': "Sponsor's Website"}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate consistency of accelerated insulin absorption and onset-of-action and shortened duration of action for bolus insulin infusions after pretreatment with 150 units (U) of Hylenex® (recombinant human hyaluronidase PH20 \\[rHuPH20\\]) injection at the time of infusion set insertion compared to sham injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or females of age 18 to 65 years, inclusive. Females of child-bearing potential must use a standard and effective means of birth control for the duration of the study.\n2. Non-smoking participants with Type 1 diabetes mellitus (T1DM) treated with insulin for ≥12 months. Nonsmoking means abstinence from cigarettes and cigars for 3 months and negative cotinine screening tests at screening.\n3. Body mass index (BMI) 18.0 to 35.0 kilograms per meter squared (kg/m²), inclusive.\n4. Glycosylated hemoglobin A1c (HbA1c) ≤10% based on local laboratory results.\n5. Fasting connecting peptide of insulin (C-peptide) \\<0.6 nanograms per milliliter (ng/mL).\n6. Current treatment with insulin \\<90 units per day (U/d).\n7. Current use of rapid acting insulin analog.\n8. Routine use of CSII as the primary route of insulin administration for at least 3 months prior to screening\n9. Participants should be in good general health based on medical history and physical examination without medical conditions that might prevent the completion of study drug infusions and assessments required in the study protocol.\n\nExclusion Criteria:\n\n1. Known or suspected allergy to any component of any of the study drugs in this study.\n2. Previous enrollment in this study.\n3. Use of drugs that may interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia. Participants taking maintenance doses of blood thinners (for example, coumadin or heparin) will be excluded.\n4. Use of any long-acting insulin injection within 72 hours of Study Day 1; participants will continue to refrain from use throughout the duration of the study (Phases I and II).\n5. Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator.\n6. Current addiction to alcohol or substances of abuse as determined by the Investigator.\n7. Blood donation or phlebotomy (\\>500 milliliters \\[mL\\]) within the previous 8 weeks of the Screening Visit(s) in this study.\n8. Pregnancy, breastfeeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device \\[IUD\\], oral or injectable contraceptives, or barrier methods).\n9. Symptomatic gastroparesis.\n10. Receipt of any investigational drug within 4 weeks of Study Day 1.'}, 'identificationModule': {'nctId': 'NCT01526733', 'briefTitle': 'Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase', 'organization': {'class': 'INDUSTRY', 'fullName': 'Halozyme Therapeutics'}, 'officialTitle': 'A Phase 4, Randomized, Double-Blind, 2-Way Crossover Study of Continuous Subcutaneous Insulin Infusion (CSII) With, Compared to Without, Pretreatment With Recombinant Human Hyaluronidase (rHuPH20)', 'orgStudyIdInfo': {'id': 'Halo-117-401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Insulin (Aspart or Lispro)-Sham', 'description': 'In Phase I or Phase II of the study, participants received 0.15 units per kilogram (U/kg) insulin (either insulin aspart or insulin lispro) as a continuous subcutaneous insulin infusion (CSII) for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.\n\nEach Phase was separated by a washout period of 5 to 21 days.', 'interventionNames': ['Drug: Sham Injection', 'Drug: Insulin aspart', 'Drug: Insulin lispro']}, {'type': 'EXPERIMENTAL', 'label': 'Insulin (Aspart or Lispro)-rHuPH20', 'description': 'In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of recombinant human hyaluronidase (rHuPH20).\n\nEach Phase was separated by a washout period of 5 to 21 days.', 'interventionNames': ['Drug: Recombinant human hyaluronidase PH20', 'Drug: Insulin aspart', 'Drug: Insulin lispro']}], 'interventions': [{'name': 'Sham Injection', 'type': 'DRUG', 'armGroupLabels': ['Insulin (Aspart or Lispro)-Sham']}, {'name': 'Recombinant human hyaluronidase PH20', 'type': 'DRUG', 'otherNames': ['rHuPH20', 'PH20', 'Hylenex'], 'armGroupLabels': ['Insulin (Aspart or Lispro)-rHuPH20']}, {'name': 'Insulin aspart', 'type': 'DRUG', 'otherNames': ['Novolog', 'Aspart'], 'armGroupLabels': ['Insulin (Aspart or Lispro)-Sham', 'Insulin (Aspart or Lispro)-rHuPH20']}, {'name': 'Insulin lispro', 'type': 'DRUG', 'otherNames': ['Humalog', 'Lispro'], 'armGroupLabels': ['Insulin (Aspart or Lispro)-Sham', 'Insulin (Aspart or Lispro)-rHuPH20']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Profil Institute for Clinical Research', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}], 'overallOfficials': [{'name': 'Linda Morrow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Profil Institute for Clinical Research, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Halozyme Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}