Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-31 @ 11:56 PM
Study NCT ID:
NCT01556594
Status:
COMPLETED
Last Update Posted:
2019-09-23
First Post:
2012-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of a Novel Glucagon Formulation in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia
Sponsor:
Organization:
Raw JSON
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Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'First dose of study drug (Day 1) until post-study completion (Day 38)', 'description': 'All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).', 'eventGroups': [{'id': 'EG000', 'title': 'SC Glucagon', 'description': 'SC glucagon injection 1 mg', 'otherNumAtRisk': 18, 'otherNumAffected': 16, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NG 1 mg', 'description': 'NG dose of 1 mg', 'otherNumAtRisk': 12, 'otherNumAffected': 9, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'NG 2 mg', 'description': 'NG dose of 2 mg', 'otherNumAtRisk': 18, 'otherNumAffected': 15, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'NG 3 mg', 'description': 'NG dose of 3 mg', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lacrimation Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 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'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ear pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ocular Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vessel Puncture Site Bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain in Jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sinus Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasal Dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 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'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cold Sweat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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{'value': '25', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-dose; 30 minutes following glucagon administration', 'description': 'Participants with a blood glucose increment of ≥1.5 millimole per liter \\[mmol/L) within 15 of nadir (5 minutes post dose) and for at least 10 minutes following nadir.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SC Glucagon', 'description': 'SC glucagon injection 1 mg'}, {'id': 'OG001', 'title': 'NG 1 mg', 'description': 'NG dose of 1 mg'}, {'id': 'OG002', 'title': 'NG 2 mg', 'description': 'NG dose of 2 mg'}, {'id': 'OG003', 'title': 'NG 3 mg', 'description': 'NG dose of 3 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 3 hours post glucagon administration', 'description': "Safety and tolerability evaluated through the assessment of adverse events. An AE was defined as any untoward medical occurrence in a clinical investigation subject administered the investigational product and which did not necessarily have a causal relationship with this treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of glucagon (SC Glucagon or NG).'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) of Baseline-Adjusted Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SC Glucagon', 'description': 'SC glucagon injection 1 mg'}, {'id': 'OG001', 'title': 'NG 1 mg', 'description': 'NG dose of 1 mg'}, {'id': 'OG002', 'title': 'NG 2 mg', 'description': 'NG dose of 2 mg'}, {'id': 'OG003', 'title': 'NG 3 mg', 'description': 'NG dose of 3 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '5.68', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '1.89', 'groupId': 'OG001'}, {'value': '3.46', 'spread': '1.44', 'groupId': 'OG002'}, {'value': '3.11', 'spread': '2.08', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration', 'unitOfMeasure': 'millimole per liter (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of glucagon (SC Glucagon or NG).'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SC Glucagon', 'description': 'SC glucagon injection 1 mg'}, {'id': 'OG001', 'title': 'NG 1 mg', 'description': 'NG dose of 1 mg'}, {'id': 'OG002', 'title': 'NG 2 mg', 'description': 'NG dose of 2 mg'}, {'id': 'OG003', 'title': 'NG 3 mg', 'description': 'NG dose of 3 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '3.0'}, {'value': '0.67', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '3.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '3.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration', 'unitOfMeasure': 'hours (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of glucagon (SC Glucagon or NG).'}, {'type': 'SECONDARY', 'title': 'Maximum Change From Baseline Concentration (Cmax) of Glucagon', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SC Glucagon', 'description': 'SC glucagon injection 1 mg'}, {'id': 'OG001', 'title': 'NG 1 mg', 'description': 'NG dose of 1 mg'}, {'id': 'OG002', 'title': 'NG 2 mg', 'description': 'NG dose of 2 mg'}, {'id': 'OG003', 'title': 'NG 3 mg', 'description': 'NG dose of 3 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '3930', 'spread': '2650', 'groupId': 'OG000'}, {'value': '504', 'spread': '342', 'groupId': 'OG001'}, {'value': '2370', 'spread': '1810', 'groupId': 'OG002'}, {'value': '1360', 'spread': '722', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration', 'unitOfMeasure': 'picograms per millilitre (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of glucagon (SC Glucagon or NG) with available pharmacokinetic data.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SC Glucagon', 'description': 'SC glucagon injection 1 mg'}, {'id': 'OG001', 'title': 'NG 1 mg', 'description': 'NG dose of 1 mg'}, {'id': 'OG002', 'title': 'NG 2 mg', 'description': 'NG dose of 2 mg'}, {'id': 'OG003', 'title': 'NG 3 mg', 'description': 'NG dose of 3 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.67'}, {'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '0.17', 'upperLimit': '0.25'}, {'value': '0.33', 'groupId': 'OG002', 'lowerLimit': '0.17', 'upperLimit': '0.50'}, {'value': '0.29', 'groupId': 'OG003', 'lowerLimit': '0.17', 'upperLimit': '0.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration', 'unitOfMeasure': 'hours (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of glucagon (SC Glucagon or NG) with available pharmacokinetic data.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SC Glucagon', 'description': 'SC glucagon injection 1 mg'}, {'id': 'OG001', 'title': 'NG 1 mg', 'description': 'NG dose of 1 mg'}, {'id': 'OG002', 'title': 'NG 2 mg', 'description': 'NG dose of 2 mg'}, {'id': 'OG003', 'title': 'NG 3 mg', 'description': 'NG dose of 3 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '2390', 'spread': '1350', 'groupId': 'OG000'}, {'value': '95.2', 'spread': '38.4', 'groupId': 'OG001'}, {'value': '886', 'spread': '796', 'groupId': 'OG002'}, {'value': '720', 'spread': '386', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration', 'unitOfMeasure': 'hour*picogram per millilitre (hr*pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of glucagon (SC Glucagon or NG) with available pharmacokinetic data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group 1', 'description': 'Nasal glucagon (NG) dose of 1 milligram (mg) and 2 mg. Subcutaneous (SC) glucagon dose of 1mg.'}, {'id': 'FG001', 'title': 'Treatment Group 2', 'description': 'NG dose of 1 mg, 2 mg and 3mg. SC glucagon dose of 1mg.'}, {'id': 'FG002', 'title': 'Treatment Group 3', 'description': 'NG dose of 2 mg and 3mg. SC glucagon dose of 1mg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Participants were recruited from the clinical site's database and from participants who responded to advertising in local media."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group 1', 'description': 'NG dose of 1 mg and 2 mg. SC glucagon dose of 1mg.'}, {'id': 'BG001', 'title': 'Treatment Group 2', 'description': 'NG dose of 1 mg, 2 mg and 3mg. SC glucagon dose of 1mg.'}, {'id': 'BG002', 'title': 'Treatment Group 3', 'description': 'NG dose of 2 mg and 3mg. SC glucagon dose of 1mg.'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'spread': '14', 'groupId': 'BG000'}, {'value': '42', 'spread': '2', 'groupId': 'BG001'}, {'value': '25', 'spread': '6', 'groupId': 'BG002'}, {'value': '32', 'spread': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-05', 'studyFirstSubmitDate': '2012-03-15', 'resultsFirstSubmitDate': '2013-03-18', 'studyFirstSubmitQcDate': '2012-03-15', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-08-09', 'studyFirstPostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Responders', 'timeFrame': 'Pre-dose; 30 minutes following glucagon administration', 'description': 'Participants with a blood glucose increment of ≥1.5 millimole per liter \\[mmol/L) within 15 of nadir (5 minutes post dose) and for at least 10 minutes following nadir.'}, {'measure': 'Number of Participants With at Least One Adverse Event', 'timeFrame': 'Within 3 hours post glucagon administration', 'description': "Safety and tolerability evaluated through the assessment of adverse events. An AE was defined as any untoward medical occurrence in a clinical investigation subject administered the investigational product and which did not necessarily have a causal relationship with this treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section."}], 'secondaryOutcomes': [{'measure': 'Maximum Concentration (Cmax) of Baseline-Adjusted Glucose', 'timeFrame': 'Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration'}, {'measure': 'Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose', 'timeFrame': 'Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration'}, {'measure': 'Maximum Change From Baseline Concentration (Cmax) of Glucagon', 'timeFrame': 'Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration'}, {'measure': 'Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon', 'timeFrame': 'Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration'}, {'measure': 'Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon', 'timeFrame': 'Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypoglycemia', 'Diabetes mellitus'], 'conditions': ['Hypoglycemia']}, 'descriptionModule': {'briefSummary': 'In this study, participants with Type 1 diabetes received insulin through an infusion into a vein to reduce their blood glucose, and then received nasal glucagon (NG) or glucagon for injection under the skin, and their blood glucose was measured for 3 hours.\n\nThe main objective of this study was to evaluate the safety and efficacy of intranasal and subcutaneous glucagon (SC) in reversing insulin-induced hypoglycemia in participants with type 1 diabetes.', 'detailedDescription': 'In the study, up to four (4) treatments were administered as a single dose either intranasally or subcutaneously to eighteen (18) male or female participants under fasting conditions and following the use of insulin to lower blood glucose. The participants were assigned at random to a group that received one treatment for each of the 3 study periods. The glucagon administrations were separated by approximately 7 calendar days. For 2 participants, a single dose of 3 mg NG was administered at the 4th period that was separated by at least 21 calendar days from the 3rd period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of type 1 diabetes between 2 and 30 years\n* Receiving daily insulin injections or insulin pump therapy for at least 2 years\n* If patient is taking Lantus, Levemir or equivalent once-daily in the evening as basal insulin, must be willing to transition to once-daily in the morning at least 48 hours prior to 1st dosing, and to follow this dosing regimen for the entire duration of the study\n* Body mass index (BMI) greater than or equal to 20.00 and below or equal to 33.00 kg/m2\n* Female patients must not be pregnant, and must be using effective contraception.\n* Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes or less per day for at least 3 months before day 1 of this study. An ex smoker is defined as someone who completely stopped smoking for at least 6 months before day 1 of this study\n\nExclusion Criteria:\n\n* History of an episode of severe hypoglycemia (as defined by an episode that required third party assistance for treatment) in the previous 6 months before day 1 of this study\n* Score ≥4 on the Clarke Hypoglycemia Awareness survey at screening\n* Presence or history of pheochromocytoma (i.e. adrenal gland tumor)\n* Presence or history of significant upper respiratory or allergic (i.e., seasonal rhinitis) disease\n* Presence of clinically significant findings on nasal examination and bilateral anterior rhinoscopy\n* Known presence of hereditary problems of galactose and /or lactose intolerance\n* History of significant hypersensitivity to glucagon or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs'}, 'identificationModule': {'nctId': 'NCT01556594', 'acronym': 'AMG102', 'briefTitle': 'Safety and Efficacy of a Novel Glucagon Formulation in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Phase II Study to Investigate the Safety and Efficacy of 2 Dose Levels of a Novel Glucagon Formulation Compared to Commercially Available Glucagon in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia', 'orgStudyIdInfo': {'id': '16416'}, 'secondaryIdInfos': [{'id': 'I8R-MC-IGBA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'AMG102', 'type': 'OTHER', 'domain': 'Locemia Solutions ULC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nasal Glucagon 1 mg', 'description': 'Nasal glucagon (NG) administered as single dose of 1 milligram (mg).', 'interventionNames': ['Drug: Nasal Glucagon 1 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Nasal Glucagon 2 mg', 'description': 'NG administered as single dose of 2 mg.', 'interventionNames': ['Drug: Nasal Glucagon 2 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SC Glucagon', 'description': 'Glucagon solution dose of 1 mg administered as a single subcutaneous (SC) injection.', 'interventionNames': ['Drug: SC Glucagon']}, {'type': 'EXPERIMENTAL', 'label': 'Nasal Glucagon 3 mg', 'description': 'NG administered as single dose of 3 mg (composed of one dose of 1 mg NG immediately followed by one dose of 2mg NG).', 'interventionNames': ['Drug: Nasal Glucagon 3 mg']}], 'interventions': [{'name': 'Nasal Glucagon 1 mg', 'type': 'DRUG', 'otherNames': ['Dry Powder Nasal Glucagon', 'AMG504-1', 'LY900018'], 'armGroupLabels': ['Nasal Glucagon 1 mg']}, {'name': 'Nasal Glucagon 2 mg', 'type': 'DRUG', 'otherNames': ['Dry Powder Nasal Glucagon', 'AMG504-1', 'LY900018'], 'armGroupLabels': ['Nasal Glucagon 2 mg']}, {'name': 'SC Glucagon', 'type': 'DRUG', 'otherNames': ['Glucagon', 'Glucagon for injection (rDNA origin)'], 'armGroupLabels': ['SC Glucagon']}, {'name': 'Nasal Glucagon 3 mg', 'type': 'DRUG', 'otherNames': ['Dry Powder Nasal Glucagon', 'AMG504-1', 'LY900018'], 'armGroupLabels': ['Nasal Glucagon 3 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3P 3P1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Algorithme Pharma', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Locemia Solutions ULC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}