Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-02 @ 3:09 AM
Study NCT ID:
NCT00883558
Status:
COMPLETED
Last Update Posted:
2014-09-08
First Post:
2009-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection 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'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061268', 'term': 'Insulin Lispro'}, {'id': 'D007328', 'term': 'Insulin'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}], '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'}, {'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}]}}, '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 written permission from the sponsor (Halozyme) is obtained.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'An adverse event was considered treatment-emergent if the start date of the event was on or after the date of randomization.', 'eventGroups': [{'id': 'EG000', 'title': 'INSULIN-PH20 NP Treatment Period', 'description': "100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months.", 'otherNumAtRisk': 45, 'otherNumAffected': 17, 'seriousNumAtRisk': 45, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Insulin Lispro Treatment Period', 'description': "100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months.", 'otherNumAtRisk': 43, 'otherNumAffected': 11, 'seriousNumAtRisk': 43, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Postprandial Glucose Excursion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'INSULIN-PH20 NP', 'description': "100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months."}, {'id': 'OG001', 'title': 'Insulin Lispro', 'description': "100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months."}], 'classes': [{'categories': [{'measurements': [{'value': '17.23', 'spread': '36.040', 'groupId': 'OG000'}, {'value': '14.47', 'spread': '35.113', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3217', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '3.06', 'ciUpperLimit': '14.11', 'groupDescription': 'A total of at least 40 participants were to be enrolled in the study, and 30 participants were expected to complete both treatment cycles. Assuming a standard deviation for blood glucose of 45 milligrams per deciliter (mg/dL) and a true difference between the treatments of 0 mg/dL, the study had approximately 80% power to show that INSULIN-PH20 NP was non-inferior to insulin lispro with respect to the overall two-hour postprandial blood glucose excursion.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Adjustments included treatment, phase, and treatment sequence as fixed effects and participant within treatment sequence as a random effect.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority of INSULIN-PH20 NP to insulin lispro was supported if the upper limit of the one-sided 95% confidence interval for the difference in blood glucose between the treatments did not exceed 21.6 mg/dL.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 14 and Week 26', 'description': 'A 2-hour postprandial glucose excursion was measured for 3 meals over 3 days during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle). For each of the 3 days, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal value as determined by 8-point glucose monitoring. The average of all excursions over the 3 days for the corresponding treatment cycle is presented.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both treatment cycles with evaluable postprandial glucose data.'}, {'type': 'SECONDARY', 'title': 'Time Spent With Blood Glucose Value Outside a 71-139 Milligrams Per Deciliter (mg/dL) Range During Continuous Glucose Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'INSULIN-PH20 NP', 'description': "100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months."}, {'id': 'OG001', 'title': 'Insulin Lispro', 'description': "100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months."}], 'classes': [{'categories': [{'measurements': [{'value': '14.58', 'spread': '3.155', 'groupId': 'OG000'}, {'value': '13.37', 'spread': '3.933', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 14 and Week 26', 'description': "Participants were provided a continuous glucose monitoring (CGM) device, consisting of a sensor, transmitter, and receiver. Total time the participant's blood glucose was outside the 71-139 mg/dL range during 3 days of CGM during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle) is presented.", 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that completed both treatment cycles with evaluable CGM data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'INSULIN-PH20 NP', 'description': "100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months."}, {'id': 'OG001', 'title': 'Insulin Lispro', 'description': "100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months."}], 'classes': [{'title': 'Overall', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Severe HE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 29', 'description': 'The number of participants with at least one hypoglycemic event (HE) reported during the entire study is presented. Additionally, the number of participants with severe HEs (those that necessitated administration of carbohydrate or glucagon, or resuscitation, by another person) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Enrolled Participants', 'description': "Prior to randomization, all enrolled participants underwent a 1-month dose titration period.\n\nInsulin Lispro (Titration Period): 100 units per milliliter (U/mL), injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 1 month.\n\nParticipants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."}, {'id': 'FG001', 'title': 'INSULIN-PH20 NP First, Then Insulin Lispro', 'description': "Following a 1-month dose titration period, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.\n\nINSULIN-PH20 NP (Treatment A): 100 units per milliliter (U/mL) non-preserved (NP) formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months.\n\nInsulin Lispro (Treatment B): 100 U/mL insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months.\n\nParticipants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."}, {'id': 'FG002', 'title': 'Insulin Lispro First, Then INSULIN-PH20 NP', 'description': "Following a 1-month dose titration period, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.\n\nInsulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months.\n\nINSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 3 months.\n\nParticipants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."}], 'periods': [{'title': 'Titration Period (Weeks 0 to 4)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'First Treatment Cycle (Weeks 4 to 16)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Second Treatment Cycle (Weeks 16 to 28)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Randomized Participants', 'description': 'Following a 1-month titration period, participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle.\n\nINSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of regular human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, doses titrated to each participant individually.\n\nInsulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, doses titrated to each participant individually.\n\nThroughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine or maintained their usual regimen through an insulin pump.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.6', 'spread': '13.28', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '44', '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': '44', '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': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Participants who were randomized and received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-28', 'studyFirstSubmitDate': '2009-04-15', 'resultsFirstSubmitDate': '2014-08-28', 'studyFirstSubmitQcDate': '2009-04-15', 'lastUpdatePostDateStruct': {'date': '2014-09-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-28', 'studyFirstPostDateStruct': {'date': '2009-04-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial Glucose Excursion', 'timeFrame': 'Week 14 and Week 26', 'description': 'A 2-hour postprandial glucose excursion was measured for 3 meals over 3 days during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle). For each of the 3 days, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal value as determined by 8-point glucose monitoring. The average of all excursions over the 3 days for the corresponding treatment cycle is presented.'}], 'secondaryOutcomes': [{'measure': 'Time Spent With Blood Glucose Value Outside a 71-139 Milligrams Per Deciliter (mg/dL) Range During Continuous Glucose Monitoring', 'timeFrame': 'Week 14 and Week 26', 'description': "Participants were provided a continuous glucose monitoring (CGM) device, consisting of a sensor, transmitter, and receiver. Total time the participant's blood glucose was outside the 71-139 mg/dL range during 3 days of CGM during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle) is presented."}, {'measure': 'Number of Participants With Hypoglycemic Events', 'timeFrame': 'Baseline through Week 29', 'description': 'The number of participants with at least one hypoglycemic event (HE) reported during the entire study is presented. Additionally, the number of participants with severe HEs (those that necessitated administration of carbohydrate or glucagon, or resuscitation, by another person) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recombinant human hyaluronidase (rHuPH20)', 'Insulin lispro', 'regular human insulin'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'Insulin lispro is approved by the Food and Drug Administration (FDA) for the treatment of diabetes mellitus. Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid to the absorption and dispersion of other injectable drugs. In this study, rHuPH20 combined with a non-preserved (NP) formulation of regular human insulin (INSULIN-PH20 NP) will be compared to insulin lispro with respect to absorption and action of insulin.', 'detailedDescription': 'The purpose of this study is to compare the safety and tolerability of INSULIN-PH20 NP versus insulin lispro alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 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.\n* Participants with Type 1 diabetes mellitus (T1DM) (per World Health Organization \\[WHO\\] criteria) treated with insulin for ≥24 months.\n* Participants who use an insulin infusion pump for basal insulin administration must be on the device for at least 90 days prior to screening.\n* Body mass index (BMI) 18.0 to 35.0 kilograms per square meter (kg/m\\^2), inclusive.\n* Glycosylated hemoglobin A1c (HbA1c) ≤7.5 % based on central laboratory screening results.\n* Fasting C-peptide \\<0.6 nanograms per milliliter (ng/mL).\n* Participants should be in good general health based on medical history and physical examination and without medical conditions that might prevent the completion of study drug injections and assessments required in this protocol.\n\nExclusion Criteria:\n\n* Known or suspected allergy to any component of any of the study drugs in this study.\n* Previous enrollment in this study. Participants who fail Screening may attempt to rescreen into the study.\n* A participant who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.\n* As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including a history of arrhythmia or conduction delays on electrocardiogram \\[ECG\\]), hepatic, neurological, renal, genitourinary, or hematological systems.\n* 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). Three attempts may be performed to measure blood pressure.\n* History of any illness or disease that in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the study drugs to the participant.\n* As judged by the Investigator, clinically significant findings in routine laboratory data.\n* Use of drugs (such as systemic corticosteroids) 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.\n* Recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the Investigator.\n* Current addiction to alcohol or substances of abuse, as determined by the Investigator.\n* Pregnancy, breast-feeding, 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).\n* Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study.\n* Receipt of any investigational drug within 4 weeks of Screening.\n* Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will interfere with study participation or evaluation of data. Examples would include: renal insufficiency (serum creatinine \\>1.5 milligrams per deciliter \\[mg/dL\\] for males or \\>1.4 mg/dL for females), congestive heart failure required medication treatment, and cardiac disease with New York Heart Association (NYHA) Functional Capacity of III/IV.'}, 'identificationModule': {'nctId': 'NCT00883558', 'briefTitle': 'Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Halozyme Therapeutics'}, 'officialTitle': 'A Phase II, Randomized, Open Label, 2-Way Crossover, Safety Study of Subcutaneously Injected Prandial INSULIN-PH20 NP Compared to Insulin Analog Injection in Patients With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'HALO-117-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INSULIN-PH20 NP / Insulin Lispro', 'description': 'All enrolled participants underwent a 1-month dose titration period and received 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC) pre-meals, with doses titrated to each participant individually.\n\nNext participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle.\n\nINSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of regular human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, doses titrated to each participant individually.\n\nInsulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, doses titrated to each participant individually.\n\nThroughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine or maintained their usual regimen through an insulin pump.', 'interventionNames': ['Drug: Insulin Lispro', 'Drug: regular human insulin', 'Drug: recombinant human hyaluronidase PH20', 'Drug: Insulin glargine']}], 'interventions': [{'name': 'Insulin Lispro', 'type': 'DRUG', 'otherNames': ['Humalog'], 'armGroupLabels': ['INSULIN-PH20 NP / Insulin Lispro']}, {'name': 'regular human insulin', 'type': 'DRUG', 'otherNames': ['Humulin R'], 'armGroupLabels': ['INSULIN-PH20 NP / Insulin Lispro']}, {'name': 'recombinant human hyaluronidase PH20', 'type': 'DRUG', 'otherNames': ['Hylenex', 'rHuPH20', 'PH20'], 'armGroupLabels': ['INSULIN-PH20 NP / Insulin Lispro']}, {'name': 'Insulin glargine', 'type': 'DRUG', 'otherNames': ['Lantus'], 'armGroupLabels': ['INSULIN-PH20 NP / Insulin Lispro']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center for Childhood Diabetes', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Diabetes Research Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '59701', 'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'facility': 'Mercury Street Medical', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '27713', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Diabetes Care Center/Highgate Specialty Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Diabetes and Endocrinology', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '98502', 'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'facility': 'West Olympia Internal Medicine', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}], 'overallOfficials': [{'name': 'Douglas Muchmore, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Halozyme Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Halozyme Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}