Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT02937558
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2016-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044903', 'term': 'Congenital Hyperinsulinism'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic 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': 'xerisclintrials@xerispharma.com', 'phone': '312-517-1461', 'title': 'Khaled Junaidi', 'organization': 'Xeris Pharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the time of informed consent through last administration of the investigational product, which was a maximum of 72 hours.', 'eventGroups': [{'id': 'EG000', 'title': 'CSI-Glucagon (Double-Blind)', 'description': 'Glucagon solution delivered as a continuous subcutaneous infusion via a patch pump at a starting dosage of 5 mcg/kg/hr.\n\nGlucagon: Room-temperature-stable, non-aqueous injectable liquid formulation of synthetic glucagon peptide', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Vehicle solution delivered as a 24-hour continuous subcutaneous infusion via a patch pump.\n\nPlacebo: Isotonic saline', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'CSI-Glucagon (Open-Label)', 'description': 'Glucagon solution delivered as a continuous subcutaneous infusion via a patch pump at a starting dosage of 5 mcg/kg/hr.\n\nGlucagon: Room-temperature-stable, non-aqueous injectable liquid formulation of synthetic glucagon peptide', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Clinically Meaningful Reduction in Glucose Infusion Rate (Double-Blind)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSI-Glucagon', 'description': 'Glucagon solution delivered as a continuous subcutaneous infusion via a patch pump at a starting dosage of 5 mcg/kg/hr.\n\nGlucagon: Room-temperature-stable, non-aqueous injectable liquid formulation of synthetic glucagon peptide'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Vehicle solution delivered as a 24-hour continuous subcutaneous infusion via a patch pump.\n\nPlacebo: Isotonic saline'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to end of blinded treatment at 24 or 48 hours', 'description': 'Change from baseline in glucose infusion rate (GIR) will be determined for each subject at 24 and 48 hours from the start of blinded treatment. Subjects with a decrease in GIR ≥ 20% at 24 hours, and ≥ 33% at 48 hours will be considered to have had a clinically meaningful treatment response.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable subjects'}, {'type': 'SECONDARY', 'title': 'Percent Change in GIR (Double-Blind)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSI-Glucagon', 'description': 'Glucagon solution delivered as a continuous subcutaneous infusion via a patch pump at a starting dosage of 5 mcg/kg/hr.\n\nGlucagon: Room-temperature-stable, non-aqueous injectable liquid formulation of synthetic glucagon peptide'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Vehicle solution delivered as a 24-hour continuous subcutaneous infusion via a patch pump.\n\nPlacebo: Isotonic saline'}], 'classes': [{'categories': [{'measurements': [{'value': '-50.1', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '45.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to the end of blinded treatment at 24 or 48 hours', 'description': 'The groups will be compared for mean percent change in GIR from baseline to the end of the double-blind study phase.', 'unitOfMeasure': '% change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable subjects'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Clinically Meaningful Reduction in Glucose Infusion Rate (Open-Label)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSI-Glucagon', 'description': 'Glucagon solution delivered as a continuous subcutaneous infusion via a patch pump at a starting dosage of 5 mcg/kg/hr.\n\nGlucagon: Room-temperature-stable, non-aqueous injectable liquid formulation of synthetic glucagon peptide'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Vehicle solution delivered as a 24-hour continuous subcutaneous infusion via a patch pump.\n\nPlacebo: Isotonic saline'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to the end of open-label treatment at 72 hours', 'description': 'Change from baseline in glucose infusion rate (GIR) will be determined for each subject at the end of open-label treatment. Subjects with a decrease in GIR ≥ 33% will be considered to have had a clinically meaningful treatment response.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable subjects'}, {'type': 'SECONDARY', 'title': 'Percent Change in Glucose Infusion Rate (Open-Label)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSI-Glucagon', 'description': 'Glucagon solution delivered as a continuous subcutaneous infusion via a patch pump at a starting dosage of 5 mcg/kg/hr.\n\nGlucagon: Room-temperature-stable, non-aqueous injectable liquid formulation of synthetic glucagon peptide'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Vehicle solution delivered as a 24-hour continuous subcutaneous infusion via a patch pump.\n\nPlacebo: Isotonic saline'}], 'classes': [{'categories': [{'measurements': [{'value': '-51.2', 'spread': '10.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to end of treatment at 72 hours', 'description': 'The groups will be compared for mean percent change in GIR from baseline to the end of the open-label study phase.', 'unitOfMeasure': '% change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CSI-Glucagon', 'description': 'Glucagon solution delivered as a continuous subcutaneous infusion via a patch pump at a starting dosage of 5 mcg/kg/hr.\n\nGlucagon: Room-temperature-stable, non-aqueous injectable liquid formulation of synthetic glucagon peptide'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Vehicle solution delivered as a 24-hour continuous subcutaneous infusion via a patch pump.\n\nPlacebo: Isotonic saline'}], 'periods': [{'title': 'Double-blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Open-label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 5 subjects were randomized to active or placebo treatment during the double-blind phase of the study. All subjects completing double-blind treatment were eligible for open-label in-patient treatment with CSI Glucagon.', 'preAssignmentDetails': 'The first enrolled subject was not deemed evaluable for responsive to glucagon based upon prior history of glucagon resistance, per investigator.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CSI-Glucagon', 'description': 'Glucagon solution delivered as a continuous subcutaneous infusion via a patch pump at a starting dosage of 5 mcg/kg/hr.\n\nGlucagon: Room-temperature-stable, non-aqueous injectable liquid formulation of synthetic glucagon peptide'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Vehicle solution delivered as a 24-hour continuous subcutaneous infusion via a patch pump.\n\nPlacebo: Isotonic saline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '12.49', 'groupId': 'BG000'}, {'value': '78.5', 'spread': '79.90', 'groupId': 'BG001'}, {'value': '46.4', 'spread': '50.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-09', 'size': 848414, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-09-26T17:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-25', 'studyFirstSubmitDate': '2016-10-14', 'resultsFirstSubmitDate': '2019-09-26', 'studyFirstSubmitQcDate': '2016-10-14', 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-25', 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Clinically Meaningful Reduction in Glucose Infusion Rate (Double-Blind)', 'timeFrame': 'Baseline to end of blinded treatment at 24 or 48 hours', 'description': 'Change from baseline in glucose infusion rate (GIR) will be determined for each subject at 24 and 48 hours from the start of blinded treatment. Subjects with a decrease in GIR ≥ 20% at 24 hours, and ≥ 33% at 48 hours will be considered to have had a clinically meaningful treatment response.'}], 'secondaryOutcomes': [{'measure': 'Percent Change in GIR (Double-Blind)', 'timeFrame': 'Baseline to the end of blinded treatment at 24 or 48 hours', 'description': 'The groups will be compared for mean percent change in GIR from baseline to the end of the double-blind study phase.'}, {'measure': 'Number of Subjects With Clinically Meaningful Reduction in Glucose Infusion Rate (Open-Label)', 'timeFrame': 'Baseline to the end of open-label treatment at 72 hours', 'description': 'Change from baseline in glucose infusion rate (GIR) will be determined for each subject at the end of open-label treatment. Subjects with a decrease in GIR ≥ 33% will be considered to have had a clinically meaningful treatment response.'}, {'measure': 'Percent Change in Glucose Infusion Rate (Open-Label)', 'timeFrame': 'Baseline to end of treatment at 72 hours', 'description': 'The groups will be compared for mean percent change in GIR from baseline to the end of the open-label study phase.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hypoglycemia'], 'conditions': ['Congenital Hyperinsulinism']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial with open-label follow-up designed to assess the efficacy of Xeris Glucagon delivered as a continuous subcutaneous infusion to prevent hypoglycemia with lower intravenous glucose infusion rates in children \\< 1 year of age with congenital hyperinsulinism.', 'detailedDescription': 'This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind (DB) parallel group study with open-label follow-up designed to evaluate the efficacy of CSI-Glucagon™ for the prevention of hypoglycemia with lower IV glucose infusion rates when delivered subcutaneously to patients up to 1 year of age with congenital hyperinsulinism. CSI-Glucagon™ is expected to provide a better inpatient treatment option compared to the current standard of care.\n\nThe study will consist of three phases:\n\n1. Baseline Phase: First is a baseline stabilization phase during which concomitant therapy with octreotide and diazoxide will be safely weaned and continuous enteric feed will be held constant to the degree possible, with the only factors varying being meal size and IV glucose infusion rate (GIR) adjusted by a set plasma glucose measurement driven algorithm.\n2. Blinded, Randomized Treatment Phase: Following the stabilization phase, subjects will be randomly assigned to blinded treatment with either glucagon or placebo, which will be delivered for up to 48 hours with an OmniPod® infusion pump with the controller set to a starting basal rate for glucagon of 5 μg/kg/hr and GIR adjustments used to maintain euglycemia. After 48 hours of blinded treatment, all subjects will transition to open-label active treatment. However, if GIR reduction from baseline is \\< 20% at 24 hours, subjects will be transitioned early to the open-label phase.\n3. Open-label Treatment Phase: The third study period will involve use of CSI-Glucagon™ to manage blood glucose with minimal GIR for up to 28 days of cumulative exposure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with hyperinsulinism:\n\n a. Biochemical; detectable insulin (i.e., ≥1 µIU/L) at time of hypoglycemia (i.e, blood glucose \\<50 mg/dl), and/or suppressed free fatty acids (FFA), and/or suppressed beta-hydroxybutyrate (BOHB) and/or glycemic response to glucagon at time of hypoglycemia.\n2. Absolute necessity of intravenous glucose to prevent hypoglycemia:\n\n 1. Having failed diazoxide therapy as defined by inadequacy of 5 days maximum dose of diazoxide to eliminate the need for IV glucose, not necessarily that diazoxide has no effect.\n 2. May be on diazoxide and/or octreotide, but these drugs will be weaned off prior to randomization.\n 3. May be on dextrose feeds.\n3. Patient may be a participant in other study protocols such as observational studies, as long as no investigational intervention has taken place within 24 hrs. prior to screening.\n4. Less than 12 months of age at screening.\n\nExclusion Criteria:\n\n1. History of allergy to glucagon or excipients in the CSI-Glucagon formulation.\n2. Currently receiving, or less than 12 hours removed from IV glucagon treatment that resulted in a best achievable GIR \\> 8 mg/(kg\\*min), prior to the start of study drug.\n3. Diazoxide naïve or within five days of starting diazoxide.\n4. Receiving steroids at doses larger than 20 mg/m2/day (hydrocortisone equivalent).\n5. Patients with sepsis.\n6. Receiving alpha or beta agonists for blood pressure support.\n7. Received an investigational or other study drug within 5 half-lives of drug.\n8. Body weight less than or equal to 2.3 kg/5.0 lbs.\n9. History of pancreatectomy and GIR \\< 8 mg/(kg\\*min) after weaning of all concomitant therapies.'}, 'identificationModule': {'nctId': 'NCT02937558', 'briefTitle': 'CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xeris Pharmaceuticals'}, 'officialTitle': 'A Phase 2 Proof-of-Concept Study of CSI-Glucagon™ (Continuous Subcutaneous Glucagon Infusion) to Prevent Hypoglycemia With Lower Intravenous Glucose Infusion Rates in Children up to One Year of Age With Congenital Hyperinsulinism', 'orgStudyIdInfo': {'id': 'XSGO-CH01'}, 'secondaryIdInfos': [{'id': '1R44DK105691-01', 'link': 'https://reporter.nih.gov/quickSearch/1R44DK105691-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CSI-Glucagon (Double-Blind Phase - 2 days)', 'description': 'Glucagon solution delivered as a continuous subcutaneous infusion via a patch pump at a starting dosage of 5 mcg/kg/hr.', 'interventionNames': ['Drug: Glucagon']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Double-Blind Phase - 2 days)', 'description': 'Vehicle solution delivered as a 24-hour continuous subcutaneous infusion via a patch pump.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'CSI-Glucagon (Open-label Phase - Up to 28 days)', 'description': 'Glucagon solution delivered as a continuous subcutaneous infusion via a patch pump at a starting dosage of 5 mcg/kg/hr.', 'interventionNames': ['Drug: Glucagon']}], 'interventions': [{'name': 'Glucagon', 'type': 'DRUG', 'otherNames': ['CSI-Glucagon (continuous subcutaneous glucagon infusion)'], 'description': 'Room-temperature-stable, non-aqueous injectable liquid formulation of synthetic glucagon peptide', 'armGroupLabels': ['CSI-Glucagon (Double-Blind Phase - 2 days)', 'CSI-Glucagon (Open-label Phase - Up to 28 days)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Isotonic saline', 'armGroupLabels': ['Placebo (Double-Blind Phase - 2 days)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "UCLA Mattel Children's Hospital", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF School of Medicine, Division of Pediatric Endocrinology', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '63130', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "Washington University, St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': "Cook Children's Medical Center", 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Baylor College of Medicine, Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xeris Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}