Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-17 @ 12:29 PM
Study NCT ID:
NCT02656069
Status:
COMPLETED
Last Update Posted:
2018-10-30
First Post:
2016-01-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005934', 'term': 'Glucagon'}], 'ancestors': [{'id': 'D052336', 'term': 'Proglucagon'}, {'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': 'mcummins@xerispharma.com', 'phone': '806-282-2120', 'title': 'Martin J. Cummins, VP, Clinical Development', 'organization': 'Xeris Pharamaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'For the first intervention, treatment emergent adverse events were defined as adverse events occurring at any time after receipt of the first intervention and prior to receipt of the second intervention, 7-28 days later. For the second intervention, treatment emergent adverse events were defined as adverse events occurring at any time after receipt of the second intervention and prior to completion of the follow-up evaluation visit occurring 3-14 days later.', 'eventGroups': [{'id': 'EG000', 'title': 'G-Pen', 'description': 'A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 24, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lilly Glucagon', 'description': 'A single 1 mg subcutaneous (SC) injection of Lilly Glucagon', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 16, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'seriousEvents': [{'term': 'hyperinsulinemic hypoglycemia', 'notes': 'The evening after receiving Lilly Glucagon 1 mg, a subject had severe hypoglycemia at home requiring 3rd party assistance. An emergency medical technician administered saline. The subject recovered with no sequelae and completed the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hypoglycemia Rescue: Intent-to-Treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'G-Pen', 'description': 'A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)'}, {'id': 'OG001', 'title': 'Lilly Glucagon', 'description': 'A single 1 mg subcutaneous (SC) injection of Lilly Glucagon'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 minutes following administration of study drug', 'description': 'Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received'}, {'type': 'PRIMARY', 'title': 'Hypoglycemia Rescue: Per Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'G-Pen', 'description': 'A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)'}, {'id': 'OG001', 'title': 'Lilly Glucagon', 'description': 'A single 1 mg subcutaneous (SC) injection of Lilly Glucagon'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 minutes following administration of study drug', 'description': 'Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, treated subjects without a major protocol violation'}, {'type': 'PRIMARY', 'title': 'Hypoglycemia Rescue: Alternate Glucose Response Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'G-Pen', 'description': 'A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)'}, {'id': 'OG001', 'title': 'Lilly Glucagon', 'description': 'A single 1 mg subcutaneous (SC) injection of Lilly Glucagon'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 minutes following administration of study drug', 'description': 'Number of subjects with either an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL or an increase in from baseline in plasma glucose concentration of at least 20 mg/dL within 30 minutes after administration of glucagon', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received'}, {'type': 'SECONDARY', 'title': 'Plasma Glucose Area Under the Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'G-Pen', 'description': 'A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)'}, {'id': 'OG001', 'title': 'Lilly Glucagon', 'description': 'A single 1 mg subcutaneous (SC) injection of Lilly Glucagon'}], 'classes': [{'categories': [{'measurements': [{'value': '11651.4', 'spread': '2406.9', 'groupId': 'OG000'}, {'value': '12260.4', 'spread': '2134.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At -5, 0, 10, 20, 30, 45, 60, and 90 minutes following administration of glucagon', 'description': 'Pharmacodynamic endpoint of plasma glucose AUC from baseline to 90 minutes following administration of glucagon', 'unitOfMeasure': 'mg*min/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received'}, {'type': 'SECONDARY', 'title': 'Plasma Glucose Maximum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'G-Pen', 'description': 'A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)'}, {'id': 'OG001', 'title': 'Lilly Glucagon', 'description': 'A single 1 mg subcutaneous (SC) injection of Lilly Glucagon'}], 'classes': [{'categories': [{'measurements': [{'value': '202.7', 'spread': '41.8', 'groupId': 'OG000'}, {'value': '193.5', 'spread': '42.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon', 'description': 'Pharmacodynamic endpoint of plasma glucose Cmax from baseline to 4 hours following administration of glucagon', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received'}, {'type': 'SECONDARY', 'title': 'Plasma Glucose Time to Maximum Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'G-Pen', 'description': 'A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)'}, {'id': 'OG001', 'title': 'Lilly Glucagon', 'description': 'A single 1 mg subcutaneous (SC) injection of Lilly Glucagon'}], 'classes': [{'categories': [{'measurements': [{'value': '111.3', 'spread': '33.5', 'groupId': 'OG000'}, {'value': '100.4', 'spread': '42.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon', 'description': 'Pharmacodynamic endpoint of plasma glucose Tmax from baseline to 4 hours following administration of glucagon', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received'}, {'type': 'SECONDARY', 'title': 'Plasma Glucose Time to Concentration > 70 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'G-Pen', 'description': 'A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)'}, {'id': 'OG001', 'title': 'Lilly Glucagon', 'description': 'A single 1 mg subcutaneous (SC) injection of Lilly Glucagon'}], 'classes': [{'categories': [{'measurements': [{'value': '19.9', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '4.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon', 'description': 'Pharmacodynamic endpoint of time to achieve a plasma glucose concentration \\> 70 mg/dL following administration of glucagon', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received'}, {'type': 'SECONDARY', 'title': 'Time to Resolution of Hypoglycemia Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'G-Pen', 'description': 'A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)'}, {'id': 'OG001', 'title': 'Lilly Glucagon', 'description': 'A single 1 mg subcutaneous (SC) injection of Lilly Glucagon'}], 'classes': [{'title': 'Autonomic Symptoms', 'categories': [{'measurements': [{'value': '16.0', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'Neuroglycopenic Symptoms', 'categories': [{'measurements': [{'value': '16.7', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '9.0', 'groupId': 'OG001'}]}]}, {'title': 'All Symptoms', 'categories': [{'measurements': [{'value': '19.8', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '8.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 minutes following administration of glucagon', 'description': 'Time to resolution of mean autonomic, mean neuroglycopenic and mean total hypoglycemia symptom scores from baseline through 90 minutes following administration of glucagon.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received'}, {'type': 'SECONDARY', 'title': 'Global Assessment of Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'G-Pen', 'description': 'A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)'}, {'id': 'OG001', 'title': 'Lilly Glucagon', 'description': 'A single 1 mg subcutaneous (SC) injection of Lilly Glucagon'}], 'classes': [{'categories': [{'measurements': [{'value': '16.8', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '15.7', 'spread': '8.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 minutes following administration of glucagon', 'description': 'Time to resolution of the overall sensation of hypoglycemia following administration of glucagon', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received'}, {'type': 'POST_HOC', 'title': 'Hypoglycemia Rescue: Glucose or Symptomatic Response Definition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'G-Pen', 'description': 'A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection)'}, {'id': 'OG001', 'title': 'Lilly Glucagon', 'description': 'A single 1 mg subcutaneous (SC) injection of Lilly Glucagon'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 30 minutes following administration of study drug', 'description': 'Number of subjects with either an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL or resolution of all neuroglycopenic symptoms of hypoglycemia within 30 minutes after administration of glucagon', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'G-Pen First, Then Lilly Glucagon', 'description': 'A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection) with a 7-28 day wash-out, followed by a single 1 mg SC injection of Lilly Glucagon (glucagon injection \\[rDNA origin\\])\n\nG-Pen™ (glucagon injection): 1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector\n\nLilly Glucagon (glucagon injection \\[rDNA origin\\]): 1 mg of Lilly glucagon reconstituted from lyophilized powder'}, {'id': 'FG001', 'title': 'Lilly Glucagon First, Then G-Pen', 'description': 'A single 1 mg SC injection of Lilly Glucagon (glucagon injection \\[rDNA origin\\]) with a 7-28 day wash-out, followed by a single 1 mg SC injection of G-Pen™ (glucagon injection)\n\nLilly Glucagon (glucagon injection \\[rDNA origin\\]): 1 mg of Lilly glucagon reconstituted from lyophilized powder\n\nG-Pen™ (glucagon injection): 1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The recruitment period began 15 March 2017 and ran through 30 June 2017. Subjects were screened for study eligibility at one of the 7 clinical sites up to 60 days prior to randomization.', 'preAssignmentDetails': 'A total of 6 screened and eligible subjects were not randomized to one of the treatment sequences due to closing of the enrollment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'G-Pen First, Then Lilly Glucagon', 'description': 'A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection) with a 7-28 day wash-out, followed by a single 1 mg SC injection of Lilly Glucagon (glucagon injection \\[rDNA origin\\])\n\nG-Pen™ (glucagon injection): 1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector\n\nLilly Glucagon (glucagon injection \\[rDNA origin\\]): 1 mg of Lilly glucagon reconstituted from lyophilized powder'}, {'id': 'BG001', 'title': 'Lilly Glucagon First, Then G-Pen', 'description': 'A single 1 mg SC injection of Lilly Glucagon (glucagon injection \\[rDNA origin\\]) with a 7-28 day wash-out, followed by a single 1 mg SC injection of G-Pen™ (glucagon injection)\n\nLilly Glucagon (glucagon injection \\[rDNA origin\\]): 1 mg of Lilly glucagon reconstituted from lyophilized powder\n\nG-Pen™ (glucagon injection): 1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.1', 'spread': '15.55', 'groupId': 'BG000'}, {'value': '45.5', 'spread': '14.87', 'groupId': 'BG001'}, {'value': '43.6', 'spread': '15.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'Non-Hispanic White', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'title': 'Canada', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'United Staates', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All eligible, randomized subjects'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-16', 'size': 829707, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-31T17:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-29', 'studyFirstSubmitDate': '2016-01-12', 'resultsFirstSubmitDate': '2018-08-31', 'studyFirstSubmitQcDate': '2016-01-12', 'lastUpdatePostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-31', 'studyFirstPostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypoglycemia Rescue: Intent-to-Treat Population', 'timeFrame': 'At 30 minutes following administration of study drug', 'description': 'Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon'}, {'measure': 'Hypoglycemia Rescue: Per Protocol Population', 'timeFrame': 'At 30 minutes following administration of study drug', 'description': 'Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon'}, {'measure': 'Hypoglycemia Rescue: Alternate Glucose Response Definition', 'timeFrame': 'At 30 minutes following administration of study drug', 'description': 'Number of subjects with either an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL or an increase in from baseline in plasma glucose concentration of at least 20 mg/dL within 30 minutes after administration of glucagon'}], 'secondaryOutcomes': [{'measure': 'Plasma Glucose Area Under the Curve (AUC)', 'timeFrame': 'At -5, 0, 10, 20, 30, 45, 60, and 90 minutes following administration of glucagon', 'description': 'Pharmacodynamic endpoint of plasma glucose AUC from baseline to 90 minutes following administration of glucagon'}, {'measure': 'Plasma Glucose Maximum Concentration (Cmax)', 'timeFrame': 'At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon', 'description': 'Pharmacodynamic endpoint of plasma glucose Cmax from baseline to 4 hours following administration of glucagon'}, {'measure': 'Plasma Glucose Time to Maximum Concentration (Tmax)', 'timeFrame': 'At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon', 'description': 'Pharmacodynamic endpoint of plasma glucose Tmax from baseline to 4 hours following administration of glucagon'}, {'measure': 'Plasma Glucose Time to Concentration > 70 mg/dL', 'timeFrame': 'At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon', 'description': 'Pharmacodynamic endpoint of time to achieve a plasma glucose concentration \\> 70 mg/dL following administration of glucagon'}, {'measure': 'Time to Resolution of Hypoglycemia Symptoms', 'timeFrame': 'At 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 minutes following administration of glucagon', 'description': 'Time to resolution of mean autonomic, mean neuroglycopenic and mean total hypoglycemia symptom scores from baseline through 90 minutes following administration of glucagon.'}, {'measure': 'Global Assessment of Hypoglycemia', 'timeFrame': 'At 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 minutes following administration of glucagon', 'description': 'Time to resolution of the overall sensation of hypoglycemia following administration of glucagon'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoglycemia', 'Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '34620618', 'type': 'DERIVED', 'citation': 'Christiansen MP, Cummins M, Prestrelski S, Close NC, Nguyen A, Junaidi K. Comparison of a ready-to-use liquid glucagon injection administered by autoinjector to glucagon emergency kit for the symptomatic relief of severe hypoglycemia: two randomized crossover non-inferiority studies. BMJ Open Diabetes Res Care. 2021 Oct;9(1):e002137. doi: 10.1136/bmjdrc-2021-002137.'}]}, 'descriptionModule': {'briefSummary': 'This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen (glucagon injection) to Lilly Glucagon (glucagon for injection \\[rDNA origin\\]) for hypoglycemia rescue of adult patients with type 1 diabetes.', 'detailedDescription': 'This is a blinded, randomized, Phase 3 comparative efficacy and safety study in adults with type 1 diabetes. Patients will complete screening procedures up to 60 days before randomization to determine eligibility before enrollment to the treatment phase.\n\nThe procedure for evaluating the efficacy of the G-Pen (glucagon injection) consists of inducing hypoglycemia by intravenous administration of regular insulin diluted in normal saline. Each participant will undergo two episodes of insulin-induced hypoglycemia, and in random order will receive 1 mg G-Pen (glucagon injection) during one episode and 1 mg Lilly Glucagon during the other episode. There will be wash out period of 7-28 days between treatment visits.\n\nBlood glucose levels will be monitored post-dosing, with a return of plasma glucose to a concentration \\> 70 mg/dL within 30 minutes signifying successful hypoglycemia rescue. As a confirmation of efficacy, subjects will complete a questionnaire concerning changes in symptoms of hypoglycemia following treatment with glucagon.\n\nSubjects will return for a follow-up safety visit 3-14 days following administration of the final dose of glucagon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with type 1 diabetes mellitus for at least 24 months\n* usage of daily insulin treatment\n* random serum C-peptide concentration \\< 0.5 ng/mL\n\nExclusion Criteria:\n\n* pregnant or nursing\n* HbA1c \\>9.0%\n* renal insufficiency\n* hepatic synthetic insufficiency\n* aspartate or alanine aminotransferase \\> 3 times the upper limit of normal\n* hematocrit less than or equal to 30%\n* use of \\> 2.0 U/kg total insulin dose per day\n* inadequate bilateral venous access in both arms\n* congestive heart failure, New York Heart Association class II, III or IV\n* active malignancy within 5 years, except basal cell or squamous cell skin cancers\n* history of breast cancer or malignant melanoma\n* major surgical operation within 30 days\n* current seizure disorder.\n* current bleeding disorder, treatment with warfarin, or platelet count below 50,000\n* history of pheochromocytoma or disorder with increased risk of pheochromocytoma\n* history of insulinoma\n* history of glycogen storage disease.\n* positive for HIV, hepatitis C virus or active hepatitis B virus infection\n* whole blood donation of 1 pint (500 mL) within 8 weeks\n* active substance or alcohol abuse\n* administration of glucagon within 28 days\n* participation in other studies involving an investigational drug or device within 30 days'}, 'identificationModule': {'nctId': 'NCT02656069', 'briefTitle': 'Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xeris Pharmaceuticals'}, 'officialTitle': 'G-Pen (Glucagon Injection) Compared to Lilly Glucagon (Glucagon for Injection [RDNA Origin]) for Induced Hypoglycemia Rescue in Adult Patients With T1DM: A Phase 3, Multi-center, Randomized, Blinded, 2-Way Crossover Study to Evaluate Efficacy and Safety', 'orgStudyIdInfo': {'id': 'XSGP-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'G-Pen first, then Lilly Glucagon', 'description': 'A single 1 mg subcutaneous (SC) injection of G-Pen (glucagon injection) with a 7-28 day wash-out, followed by a single 1 mg SC injection of Lilly Glucagon (glucagon injection \\[rDNA origin\\])', 'interventionNames': ['Drug: G-Pen (glucagon injection)', 'Drug: Lilly Glucagon (glucagon injection [rDNA origin])']}, {'type': 'OTHER', 'label': 'Lilly Glucagon first, then G-Pen', 'description': 'A single 1 mg SC injection of Lilly Glucagon (glucagon injection \\[rDNA origin\\]) with a 7-28 day wash-out, followed by a single 1 mg SC injection of G-Pen (glucagon injection)', 'interventionNames': ['Drug: G-Pen (glucagon injection)', 'Drug: Lilly Glucagon (glucagon injection [rDNA origin])']}], 'interventions': [{'name': 'G-Pen (glucagon injection)', 'type': 'DRUG', 'otherNames': ['glucagon'], 'description': '1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector', 'armGroupLabels': ['G-Pen first, then Lilly Glucagon', 'Lilly Glucagon first, then G-Pen']}, {'name': 'Lilly Glucagon (glucagon injection [rDNA origin])', 'type': 'DRUG', 'otherNames': ['glucagon'], 'description': '1 mg of Lilly glucagon reconstituted from lyophilized powder', 'armGroupLabels': ['G-Pen first, then Lilly Glucagon', 'Lilly Glucagon first, then G-Pen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'ProSciento, Inc.', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'AMCR Institute', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas, Inc.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Rainier Research', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': 'M4G 3E8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LMC Diabetes & Endocrinology', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xeris Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}