Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-01-08 @ 11:57 AM
Study NCT ID:
NCT03662334
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2018-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Function in Subjects With Type 1 Diabetes With Recombinant Human Hyaluronidase (rHuPH20)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061268', 'term': 'Insulin Lispro'}], 'ancestors': [{'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': 'dchondros@halozyme.com', 'phone': '858-794-8889', 'title': 'Dimitrios Chondros, M.D., Chief Medical Officer', 'organization': 'Halozyme Therapeutics'}, '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 written permission from the sponsor (Halozyme) is obtained.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 milligrams per deciliter. The study was stopped early, prior to enrolling the planned 24 participants for Part 2.'}}, 'adverseEventsModule': {'timeFrame': '155 days', 'eventGroups': [{'id': 'EG000', 'title': 'Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of either Treatment Period 1 or Treatment Period 2. The two periods were separated by a 3- to 7-day washout period.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 4, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of either Treatment Period 1 or Treatment Period 2. The two periods were separated by a 3- to 7-day washout period.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 2, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Injection Site Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Area Under the Curve (AUC) of Glucose Infusion Rate (GIR) From 0-6 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'OG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}], 'timeFrame': '0-6 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.'}, {'type': 'PRIMARY', 'title': 'Part 2: Time to Reduction in Plasma Glucose by 80 Milligrams Per Deciliter (mg/dL) Following CSII Bolus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'OG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}], 'classes': [{'title': 'First Intervention', 'categories': [{'measurements': [{'value': '5.58', 'groupId': 'OG000'}, {'value': '5.23', 'groupId': 'OG001'}]}]}, {'title': 'Second Intervention', 'categories': [{'measurements': [{'value': '4.63', 'groupId': 'OG000'}, {'value': '5.32', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-10 hours', 'description': 'Time to reduction is reported as the maximum time it took for any participant receiving each treatment sequence to achieve a reduction in plasma glucose by 80 mg/dL. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.', 'unitOfMeasure': 'hours', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all randomized participants exposed to at least one dose of study drug'}, {'type': 'PRIMARY', 'title': 'Part 3: Time to Achieve Plasma Glucose >90 mg/dL After Release of Hypoglycemic CSII Clamp', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'OG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}], 'timeFrame': '0-12 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.'}, {'type': 'SECONDARY', 'title': 'Part 1: Time-action Profile, Assessed by GIR in Euglycemic Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'OG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}], 'timeFrame': 'up to approximately 10 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.'}, {'type': 'SECONDARY', 'title': 'Part 1: Mean Maximum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'OG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}], 'timeFrame': 'up to approximately 22 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.'}, {'type': 'SECONDARY', 'title': 'Part 1: Time to Achieve Maximum Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'OG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}], 'timeFrame': 'up to approximately 22 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.'}, {'type': 'SECONDARY', 'title': 'Part 1: Early Time to 50% Maximum Serum Insulin Concentration (t50%) Max', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'OG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}], 'timeFrame': 'up to approximately 22 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.'}, {'type': 'SECONDARY', 'title': 'Part 1: Time to 50% of Total AUC (AUC0-last)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'OG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}], 'timeFrame': 'up to approximately 22 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.'}, {'type': 'SECONDARY', 'title': 'Part 1: Fractional and Absolute AUC0-1hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'OG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}], 'timeFrame': '0 to 1 hour', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.'}, {'type': 'SECONDARY', 'title': 'Part 1: Fractional and Absolute AUC2hr-end', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'OG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}], 'timeFrame': '2 to approximately 22 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.'}, {'type': 'SECONDARY', 'title': 'Part 1: Area Under the Curve From Time Zero to the Last Measureable Concentration (AUC0-last)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'OG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}], 'timeFrame': 'up to approximately 22 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.'}, {'type': 'SECONDARY', 'title': 'Part 1: Mean Residence Time (MRT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'OG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}], 'timeFrame': 'up to approximately 22 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.'}, {'type': 'SECONDARY', 'title': 'Part 2: Plasma Glucose Concentration Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'OG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}], 'classes': [{'title': 'First Intervention', 'categories': [{'measurements': [{'value': '299', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}]}]}, {'title': 'Second Intervention', 'categories': [{'measurements': [{'value': '350', 'groupId': 'OG000'}, {'value': '445', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to approximately 10 hours', 'description': 'Plasma glucose concentration over time is reported as the maximum concentration for any participant receiving each treatment sequence. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.', 'unitOfMeasure': 'mg/dL', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Part 2: Insulin Analog Serum Concentration as a Function of Time Following Bolus Insulin Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'OG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}], 'classes': [{'title': 'First Intervention', 'categories': [{'measurements': [{'value': '1341.8', 'groupId': 'OG000'}, {'value': '805.1', 'groupId': 'OG001'}]}]}, {'title': 'Second Intervention', 'categories': [{'measurements': [{'value': '688.5', 'groupId': 'OG000'}, {'value': '1092.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to approximately 10 hours', 'description': 'Insulin analog serum concentration is reported as the maximum concentration for any participant receiving each treatment sequence. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.', 'unitOfMeasure': 'picomolar', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Part 3: Plasma Glucose Concentration Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'OG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}], 'timeFrame': 'up to approximately 12 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.'}, {'type': 'SECONDARY', 'title': 'Part 3: Insulin Analog Serum Concentration as a Function of Time Following Termination of Insulin Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'OG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}], 'timeFrame': 'up to approximately 12 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'FG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}], 'periods': [{'title': 'Part 1: Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Part 1: Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Treatment Period 1 (2 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Part 1 of the study was not conducted. Participants were enrolled starting with Part 2.', 'groupId': 'FG000', 'numSubjects': '7'}, {'comment': 'Part 1 of the study was not conducted. Participants were enrolled starting with Part 2.', 'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Treatment Period 2 (2 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Intended Changes to Clamp Procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Part 3: Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Part 3 of the study was not conducted. No participants were enrolled in this part of the study.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Part 3 of the study was not conducted. No participants were enrolled in this part of the study.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Part 3: Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'All three parts (Parts 1, 2, and 3) of this exploratory study were to use a cross-over design that would maximize efficiency while minimizing sample size. Only Part 2 of this study was conducted; thus, all 14 participants were enrolled in Part 2 only.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hyaluronidase Human Injection/Sham Injection', 'description': 'Participants received pretreatment of 1 milliliter (mL) hyaluronidase human injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 2.'}, {'id': 'BG001', 'title': 'Sham Injection/Hyaluronidase Human Injection', 'description': 'Participants received pretreatment of 1 mL sham injection on Day 1 of Treatment Period 1. After a 3- to 7-day washout period, participants received pretreatment of 1 mL hyaluronidase human injection on Day 1 of Treatment Period 2.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.6', 'spread': '8.90', 'groupId': 'BG000'}, {'value': '40.4', 'spread': '14.84', 'groupId': 'BG001'}, {'value': '42.0', 'spread': '11.87', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline data were collected in members of the Safety Population, comprised of all randomized participants exposed to at least one dose of study drug.'}}, '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': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2014-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2018-08-13', 'resultsFirstSubmitDate': '2018-10-10', 'studyFirstSubmitQcDate': '2018-09-05', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-30', 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Area Under the Curve (AUC) of Glucose Infusion Rate (GIR) From 0-6 Hours', 'timeFrame': '0-6 hours'}, {'measure': 'Part 2: Time to Reduction in Plasma Glucose by 80 Milligrams Per Deciliter (mg/dL) Following CSII Bolus', 'timeFrame': '0-10 hours', 'description': 'Time to reduction is reported as the maximum time it took for any participant receiving each treatment sequence to achieve a reduction in plasma glucose by 80 mg/dL. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.'}, {'measure': 'Part 3: Time to Achieve Plasma Glucose >90 mg/dL After Release of Hypoglycemic CSII Clamp', 'timeFrame': '0-12 hours'}], 'secondaryOutcomes': [{'measure': 'Part 1: Time-action Profile, Assessed by GIR in Euglycemic Participants', 'timeFrame': 'up to approximately 10 hours'}, {'measure': 'Part 1: Mean Maximum Concentration (Cmax)', 'timeFrame': 'up to approximately 22 hours'}, {'measure': 'Part 1: Time to Achieve Maximum Concentration (Tmax)', 'timeFrame': 'up to approximately 22 hours'}, {'measure': 'Part 1: Early Time to 50% Maximum Serum Insulin Concentration (t50%) Max', 'timeFrame': 'up to approximately 22 hours'}, {'measure': 'Part 1: Time to 50% of Total AUC (AUC0-last)', 'timeFrame': 'up to approximately 22 hours'}, {'measure': 'Part 1: Fractional and Absolute AUC0-1hr', 'timeFrame': '0 to 1 hour'}, {'measure': 'Part 1: Fractional and Absolute AUC2hr-end', 'timeFrame': '2 to approximately 22 hours'}, {'measure': 'Part 1: Area Under the Curve From Time Zero to the Last Measureable Concentration (AUC0-last)', 'timeFrame': 'up to approximately 22 hours'}, {'measure': 'Part 1: Mean Residence Time (MRT)', 'timeFrame': 'up to approximately 22 hours'}, {'measure': 'Part 2: Plasma Glucose Concentration Over Time', 'timeFrame': 'up to approximately 10 hours', 'description': 'Plasma glucose concentration over time is reported as the maximum concentration for any participant receiving each treatment sequence. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.'}, {'measure': 'Part 2: Insulin Analog Serum Concentration as a Function of Time Following Bolus Insulin Infusion', 'timeFrame': 'up to approximately 10 hours', 'description': 'Insulin analog serum concentration is reported as the maximum concentration for any participant receiving each treatment sequence. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.'}, {'measure': 'Part 3: Plasma Glucose Concentration Over Time', 'timeFrame': 'up to approximately 12 hours'}, {'measure': 'Part 3: Insulin Analog Serum Concentration as a Function of Time Following Termination of Insulin Infusion', 'timeFrame': 'up to approximately 12 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Type 1 Diabetes Mellitus', 'Type 1 Diabetes', 'T1DM', 'Continuous Subcutaneous Insulin Infusion (CSII)', 'CSII', 'Insulin pump', 'Insulin', 'rHuPH20', 'Hylenex', 'recombinant human hyaluronidase (rHuPH20)', 'Recombinant hyaluronidase'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.halozyme.com', 'label': 'Halozyme Therapeutics'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine if Hylenex recombinant leads to changes in the insulin time-action profiles and glucose responses when preadministered in the setting of continuous subcutaneous insulin infusion (CSII) compared to CSII without Hylenex recombinant (sham injection).', 'detailedDescription': 'There is a recognized need for more rapid insulin action than is available from current rapid-acting analog products. In addition, current products have inconstant absorption and action profiles over the course of infusion set life. Previous human studies of prandial insulin preparations have used co-mixtures of rHuPH20 (study drug) with insulin delivered to study participants by subcutaneous injection and have demonstrated acceleration of insulin absorption and action. CSII has been used clinically for the treatment of diabetes over the last three decades, and a previous study using a co-mixture of rHuPH20 during CSII showed that the combination resulted in a more consistent and ultrafast profile of insulin absorption and action across infusion set use as compared to rapid analog insulin alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female participants between the ages 18 and 65 years, inclusive.\n2. Females of child-bearing potential must agree to use a standard and effective means of birth control for the duration of the study. Adequate contraceptive measures include oral or injectable contraceptives, sterilization, intra-uterine device (IUD), barrier methods, or abstinence.\n3. Participants with type 1 diabetes mellitus treated with insulin (multiple daily injections or continuous subcutaneous insulin infusion \\[CSII\\]) diagnosed ≥ 12 months prior to enrollment\n4. Body mass index (BMI) 18.0 to 32.0 kilograms per meters squared (kg/m\\^2)\n5. HbA1c (glycated hemoglobin A1c) ≤ 10% based on local laboratory results\n6. Fasting C-peptide \\< 0.6 nanograms per milliliter (ng/mL)\n7. Current treatment with insulin \\<1.2 Units per kg per day (U/kg/day)\n8. Participant should be in good general health based on medical history and physical examination, without medical conditions that might prevent the completion of study drug injections and assessments required in this protocol\n\nExclusion Criteria:\n\n1. Inability to comply with study requirements as judged by the Investigator\n2. Known or suspected allergy to any component of any of the study drugs in this trial\n3. A participant who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator\n4. As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including a history of arrhythmia or conduction delays on electrocardiogram), hepatic, neurological, renal, genitourinary, or hematological systems\n5. As judged by the Investigator, uncontrolled hypertension (diastolic blood pressure ≥ 100 millimeters of mercury \\[mmHg\\] and/or systolic blood pressure ≥ 160 mmHg after 5 minutes in the supine position)\n6. History of any illness or disease that in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the study drugs to the participant\n7. As judged by the Investigator, clinically significant findings in routine laboratory data. Anemia with hemoglobin less than lower limits of normal at screening is specifically exclusionary\n8. Use of drugs that may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia, or drugs not permitted according to Hylenex recombinant package insert\n9. Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator\n10. Current addiction to alcohol or substances of abuse as determined by the Investigator\n11. Blood donation (\\> 500 mL) within the previous 8 weeks (56 days) prior to Day -1 of Treatment Period 1\n12. Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, IUD, oral or injectable contraceptives, or barrier methods)\n13. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study\n14. Participation in any other clinical trial and receipt of any investigational drug within 4 weeks of Day -1 of Treatment Period 1\n15. Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will interfere with trial participation or evaluation of data\n16. Positive for human immunodeficiency virus (HIV), Hepatitis C or Hepatitis B\n17. Tobacco and nicotine use within 3 months prior to Day 1 of Treatment Period 1 or use during the study'}, 'identificationModule': {'nctId': 'NCT03662334', 'acronym': 'HALO-117-406', 'briefTitle': 'A Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Function in Subjects With Type 1 Diabetes With Recombinant Human Hyaluronidase (rHuPH20)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Halozyme Therapeutics'}, 'officialTitle': 'A Phase 4, Double Blind, Single Center, Randomized, Cross-Over Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Functionality in Subjects With Type 1 Diabetes Comparing Pretreatment vs. No Pretreatment With Recombinant Human Hyaluronidase (rHuPH20)', 'orgStudyIdInfo': {'id': 'HALO-117-406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hylenex recombinant', 'description': 'Comparing the preadministration of Hylenex recombinant in the setting of continuous subcutaneous insulin infusion (CSII).', 'interventionNames': ['Drug: Rapid Acting insulin with pre-treatment of rHuPH20']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Injection', 'description': 'Comparing the preadministration of a sham injection in the setting of CSII.', 'interventionNames': ['Device: Sham injection']}], 'interventions': [{'name': 'Rapid Acting insulin with pre-treatment of rHuPH20', 'type': 'DRUG', 'otherNames': ['Humalog', 'Hylenex'], 'description': 'Hylenex recombinant will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area.', 'armGroupLabels': ['Hylenex recombinant']}, {'name': 'Sham injection', 'type': 'DEVICE', 'otherNames': ['placebo'], 'description': 'A sham injection will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area.', 'armGroupLabels': ['Sham Injection']}]}, '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}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Halozyme Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}