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FHIR IG analytics

Packagehl7.fhir.uv.ebm
Resource TypeResearchStudy
IdResearchStudy-267223.json
FHIR VersionR6

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Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: ResearchStudy 267223

version: 10; Last updated: 2025-12-11 20:35:21+0000; Language: en

Profile: StudyRegistryRecord

ResearchStudy Study Registration

  • activity: Registration submission
  • actual: true
  • period: 2018-01-30 --> (ongoing)

ResearchStudy Study Registration

  • activity: Results submission
  • actual: true
  • period: 2019-08-14 --> (ongoing)

ResearchStudy Study Registration

  • activity: Registration submission Quality Check
  • actual: true
  • period: 2018-01-30 --> (ongoing)

ResearchStudy Study Registration

  • activity: Results submission Quality Check
  • actual: true
  • period: 2019-09-18 --> (ongoing)

ResearchStudy Study Registration

  • activity: Record Verification
  • actual: true
  • period: ?? --> 2019-09

ResearchStudy Study Registration

  • activity: Update submission
  • actual: true
  • period: ?? --> 2019-09-18

ResearchStudy Study Registration

  • activity: Registration posting
  • actual: true
  • period: 2018-02-05 --> (ongoing)

ResearchStudy Study Registration

  • activity: Results posting
  • actual: true
  • period: 2019-10-08 --> (ongoing)

ResearchStudy Study Registration

  • activity: Primary outcome data collection
  • actual: true
  • period: ?? --> 2018-08-20

ResearchStudy Study Registration

  • activity: Update posting
  • actual: true
  • period: ?? --> 2019-10-08

Artifact Author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:

url: https://fevir.net/resources/ResearchStudy/267223

identifier: FEvIR Object Identifier/267223, https://clinicaltrials.gov/NCT03421379 (use: official, ), 16962, /I8R-JE-IGBJ, FEvIR Linking Identifier/NCT03421379 FHIR Transform

name: NCT03421379_FHIR_Transform

title: A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus

Labels

-TypeValue
*Official titleA Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients With Diabetes Mellitus

citeAs:

A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus [Database Entry: FHIR ResearchStudy Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 267223. Revised 2025-12-11. Available at: https://fevir.net/resources/ResearchStudy/267223. Computable resource at: https://fevir.net/resources/ResearchStudy/267223#json.

relatesTo

type: Transforms

target: https://clinicaltrials.gov/api/v2/studies/NCT03421379?format=json

relatesTo

type: Transformed With

target: null @ https://fevir.net/ctgovconvert

relatesTo

type: Cites

target: Seaquist E, Gimenez M, Yan Y, Matsuhisa M, Kao CY, Wadwa RP, Nagai Y, Khunti K. Nasal Glucagon Reverses Insulin-induced Hypoglycemia With Less Rebound Hyperglycemia: Pooled Analysis of Clinical Trials. J Endocr Soc. 2024 Feb 26;8(4):bvae034. doi: 10.1210/jendso/bvae034. eCollection 2024 Feb 19. (Identifier: https://pubmed.ncbi.nlm.nih.gov/38444629)

relatesTo

type: Supported With

target: null @ https://www.clinicalstudydatarequest.com

relatesTo

type: Documentation

target: application/pdf @ https://cdn.clinicaltrials.gov/large-docs/79/NCT03421379/Prot_000.pdf

relatesTo

type: Documentation

target: application/pdf @ https://cdn.clinicaltrials.gov/large-docs/79/NCT03421379/SAP_001.pdf

status: Active

primaryPurposeType: Treatment

phase: Phase 3

studyDesign: Design Masking: None (Open Label), randomized assignment, Crossover cohort design, interventional research

condition: Diabetes Mellitus

descriptionSummary:

The purpose of this study is to determine the efficacy and safety of nasal glucagon compared to intramuscular (IM) glucagon for treatment of insulin-induced hypoglycemia in Japanese participants with diabetes mellitus.

site:

classifier: IPDSharing: Yes, IPDSharingDescription: 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., IPDSharingInfoType: Study Protocol, IPDSharingInfoType: Statistical Analysis Plan (SAP), IPDSharingInfoType: Clinical Study Report (CSR), IPDSharingTimeFrame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting., IPDSharingAccessCriteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement., Does Not Accept Healthy Volunteers, Minimum Age: 18 Years, Maximum Age: 70 Years, Age Group: Adult, Age Group: Older Adult, Has Results: True, Oversight Classifier: oversightHasDmc False, Oversight Classifier: isFdaRegulatedDrug True, Oversight Classifier: isFdaRegulatedDevice False, Oversight Classifier: isUsExport True, AgreementPISponsorEmployee: False, AgreementRestrictionType: GT60, AgreementRestrictiveAgreement: True

associatedParty

name: Eli Lilly and Company

role: Sponsor

classifier: INDUSTRY

associatedParty

name: Eli Lilly and Company

role: Lead sponsor

classifier: INDUSTRY

associatedParty

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 chair

party: Eli Lilly and Company

progressStatus

state: Completed

progressStatus

state: Overall study

actual: true

period: 2018-02-21 --> 2018-08-20

Recruitments

-ActualNumberEligibility
*75NCT03421379 Eligibility Criteria

comparisonGroup

eligibility: Glucagon Nasal Powder: A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally.

comparisonGroup

eligibility: Glucagon Hydrochloride Solution: A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)

objective

type: Primary

OutcomeMeasures

-NameTypeDescriptionEndpoint
*Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced HypoglycemiaPrimary

Percentage of participants who achieved treatment success during the controlled insulin-induced hypoglycemia in participants with type 1 diabetes mellitus (T1DM) and participants with type 2 diabetes mellitus (T2DM).Treatment success is defined as an increase in plasma glucose to greater than or equal to (≥) 70 milligrams per deciliter (mg/dL) or an increase of ≥20 mg/dL from plasma glucose nadir, without receiving additional actions to increase the plasma glucose concentration. Nadir is defined as the minimum plasma glucose concentration at the time of or within 10 minutes following glucagon administration.

Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia

objective

type: Secondary

outcomeMeasure

name: Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)

type: Secondary

description:

PD assessment measured the change from Baseline in maximal blood glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride intramuscular (IM).

endpoint: Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)

outcomeMeasure

name: PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM

type: Secondary

description:

PD assessment measured the time to maximal concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM.

endpoint: PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM

outcomeMeasure

name: Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM

type: Secondary

description:

PK assessment measured the change from baseline in the area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of Glucagon Nasal Powder and Glucagon Hydrochloride IM.

endpoint: Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM

outcomeMeasure

name: PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM

type: Secondary

description:

PK assessment measured the change from baseline in maximal concentration (Cmax) of glucagon nasal powder and glucagon hydrochloride IM.

endpoint: PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM

outcomeMeasure

name: PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM

type: Secondary

description:

PK assessment measured the change from baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM.

endpoint: PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM

result: Results Section for NCT03421379


Generated Narrative: EvidenceVariable #NCT03421379-drug------glucagon-nasal-powder

name: NCT03421379_drug______glucagon_nasal_powder

title: Glucagon Nasal Powder

status: Active

description:

Administered intranasally

note:

suggested alternative name: LY900018

handling: boolean variable

classifier: Intervention Type: DRUG


Generated Narrative: EvidenceVariable #NCT03421379-drug------glucagon-hydrochloride-solution

name: NCT03421379_drug______glucagon_hydrochloride_solution

title: Glucagon Hydrochloride Solution

status: Active

description:

Administered IM

note:

suggested alternative name: GlucaGen®

handling: boolean variable

classifier: Intervention Type: DRUG


Generated Narrative: Group #NCT03421379-comparison-group-0

Artifact Author: Computable Publishing®: [System]-to-FEvIR Converter:

identifier: FEvIR Linking Identifier/NCT03421379-comparison-group-0

title: NCT03421379 Comparison Group: Glucagon Nasal Powder

status: Active

description:

A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally.

membership: Conceptual

code: Experimental

Characteristics

-CodeValue[x]Exclude
*Exposed toDrug: Glucagon Nasal Powderfalse

Generated Narrative: Group #NCT03421379-comparison-group-1

Artifact Author: Computable Publishing®: [System]-to-FEvIR Converter:

identifier: FEvIR Linking Identifier/NCT03421379-comparison-group-1

title: NCT03421379 Comparison Group: Glucagon Hydrochloride Solution

status: Active

description:

A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)

membership: Conceptual

code: Active Comparator

Characteristics

-CodeValue[x]Exclude
*Exposed toDrug: Glucagon Hydrochloride Solutionfalse

Generated Narrative: Location #NCT03421379-Location-0

name: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

address: Fukuoka 812-0025 Japan

Positions

-LongitudeLatitude
*130.4166733.6

Generated Narrative: Location #NCT03421379-Location-1

name: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

address: Tokyo 130-0004 Japan

Positions

-LongitudeLatitude
*139.6917135.6895

Generated Narrative: Location #NCT03421379-Location-2

name: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

address: Tokyo 162-0053 Japan

Positions

-LongitudeLatitude
*139.6917135.6895

Generated Narrative: Location #NCT03421379-Location-3

name: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

address: Tokyo 169-0073 Japan

Positions

-LongitudeLatitude
*139.6917135.6895

Source1

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      "membership": "conceptual",
      "code": {
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      "characteristic": [
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      "code": {
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    {
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        "postalCode": "812-0025",
        "country": "Japan"
      },
      "position": {
        "longitude": 130.41667,
        "latitude": 33.6
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    },
    {
      "resourceType": "Location",
      "id": "NCT03421379-Location-1",
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        "postalCode": "130-0004",
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      },
      "position": {
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        "latitude": 35.6895
      }
    },
    {
      "resourceType": "Location",
      "id": "NCT03421379-Location-2",
      "name": "For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.",
      "address": {
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        "postalCode": "162-0053",
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      "position": {
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        "latitude": 35.6895
      }
    },
    {
      "resourceType": "Location",
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        "postalCode": "169-0073",
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        "longitude": 139.69171,
        "latitude": 35.6895
      }
    }
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  "identifier": [
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      "value": "NCT03421379"
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        "display": "Eli Lilly and Company"
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      "type": {
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      "system": "https://fevir.net/FLI",
      "value": "NCT03421379 FHIR Transform",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    }
  ],
  "name": "NCT03421379_FHIR_Transform",
  "title": "A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus",
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      "value": "A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients With Diabetes Mellitus"
    }
  ],
  "citeAs": "A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus [Database Entry: FHIR ResearchStudy Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 267223. Revised 2025-12-11. Available at: https://fevir.net/resources/ResearchStudy/267223. Computable resource at: https://fevir.net/resources/ResearchStudy/267223#json.",
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        "url": "https://fevir.net/ctgovconvert",
        "title": "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
      }
    },
    {
      "type": "cites",
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        "identifier": {
          "system": "https://pubmed.ncbi.nlm.nih.gov",
          "value": "38444629"
        },
        "display": "Seaquist E, Gimenez M, Yan Y, Matsuhisa M, Kao CY, Wadwa RP, Nagai Y, Khunti K. Nasal Glucagon Reverses Insulin-induced Hypoglycemia With Less Rebound Hyperglycemia: Pooled Analysis of Clinical Trials. J Endocr Soc. 2024 Feb 26;8(4):bvae034. doi: 10.1210/jendso/bvae034. eCollection 2024 Feb 19."
      }
    },
    {
      "type": "supported-with",
      "targetAttachment": {
        "url": "https://www.clinicalstudydatarequest.com",
        "title": "IPD Sharing URL"
      }
    },
    {
      "type": "documentation",
      "targetAttachment": {
        "contentType": "application/pdf",
        "url": "https://cdn.clinicaltrials.gov/large-docs/79/NCT03421379/Prot_000.pdf",
        "size": "684592",
        "title": "ProtStudy Protocol",
        "creation": "2017-12-05"
      }
    },
    {
      "type": "documentation",
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        "url": "https://cdn.clinicaltrials.gov/large-docs/79/NCT03421379/SAP_001.pdf",
        "size": "444216",
        "title": "SAPStatistical Analysis Plan",
        "creation": "2018-02-02"
      }
    }
  ],
  "status": "active",
  "primaryPurposeType": {
    "coding": [
      {
        "system": "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type",
        "code": "treatment",
        "display": "Treatment"
      }
    ]
  },
  "phase": {
    "coding": [
      {
        "system": "http://terminology.hl7.org/CodeSystem/research-study-phase",
        "code": "phase-3",
        "display": "Phase 3"
      }
    ]
  },
  "studyDesign": [
    {
      "text": "Design Masking: None (Open Label)"
    },
    {
      "coding": [
        {
          "system": "https://fevir.net/sevco",
          "code": "SEVCO:01003",
          "display": "randomized assignment"
        }
      ]
    },
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  ],
  "condition": [
    {
      "text": "Diabetes Mellitus"
    }
  ],
  "descriptionSummary": "The purpose of this study is to determine the efficacy and safety of nasal glucagon compared to intramuscular (IM) glucagon for treatment of insulin-induced hypoglycemia in Japanese participants with diabetes mellitus.",
  "site": [
    {
      "reference": "#NCT03421379-Location-0",
      "type": "Location"
    },
    {
      "reference": "#NCT03421379-Location-1",
      "type": "Location"
    },
    {
      "reference": "#NCT03421379-Location-2",
      "type": "Location"
    },
    {
      "reference": "#NCT03421379-Location-3",
      "type": "Location"
    }
  ],
  "classifier": [
    {
      "text": "IPDSharing: Yes"
    },
    {
      "text": "IPDSharingDescription: 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."
    },
    {
      "text": "IPDSharingInfoType: Study Protocol"
    },
    {
      "text": "IPDSharingInfoType: Statistical Analysis Plan (SAP)"
    },
    {
      "text": "IPDSharingInfoType: Clinical Study Report (CSR)"
    },
    {
      "text": "IPDSharingTimeFrame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting."
    },
    {
      "text": "IPDSharingAccessCriteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement."
    },
    {
      "text": "Does Not Accept Healthy Volunteers"
    },
    {
      "text": "Minimum Age: 18 Years"
    },
    {
      "text": "Maximum Age: 70 Years"
    },
    {
      "text": "Age Group: Adult"
    },
    {
      "text": "Age Group: Older Adult"
    },
    {
      "text": "Has Results: True"
    },
    {
      "text": "Oversight Classifier: oversightHasDmc False"
    },
    {
      "text": "Oversight Classifier: isFdaRegulatedDrug True"
    },
    {
      "text": "Oversight Classifier: isFdaRegulatedDevice False"
    },
    {
      "text": "Oversight Classifier: isUsExport True"
    },
    {
      "text": "AgreementPISponsorEmployee: False"
    },
    {
      "text": "AgreementRestrictionType: GT60"
    },
    {
      "text": "AgreementRestrictiveAgreement: True"
    }
  ],
  "associatedParty": [
    {
      "name": "Eli Lilly and Company",
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            "code": "sponsor",
            "display": "Sponsor"
          }
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      },
      "classifier": [
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        }
      ]
    },
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        }
      ]
    },
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      "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)",
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        "display": "Eli Lilly and Company"
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  ],
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      "state": {
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            "system": "http://terminology.hl7.org/CodeSystem/research-study-status",
            "code": "completed",
            "display": "Completed"
          }
        ]
      }
    },
    {
      "state": {
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          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-status",
            "code": "overall-study",
            "display": "Overall study"
          }
        ]
      },
      "actual": true,
      "period": {
        "start": "2018-02-21",
        "end": "2018-08-20"
      }
    }
  ],
  "recruitment": {
    "actualNumber": 75,
    "eligibility": {
      "reference": "Group/267225",
      "type": "Group",
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        "type": {
          "text": "FEvIR Linking Identifier"
        },
        "system": "https://fevir.net/FLI",
        "value": "NCT03421379 Eligibility Criteria",
        "assigner": {
          "display": "Computable Publishing LLC"
        }
      },
      "display": "NCT03421379 Eligibility Criteria"
    }
  },
  "comparisonGroup": [
    {
      "eligibility": {
        "reference": "#NCT03421379-comparison-group-0",
        "type": "Group",
        "display": "Glucagon Nasal Powder: A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally."
      }
    },
    {
      "eligibility": {
        "reference": "#NCT03421379-comparison-group-1",
        "type": "Group",
        "display": "Glucagon Hydrochloride Solution: A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)"
      }
    }
  ],
  "objective": [
    {
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "primary",
            "display": "Primary"
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        ]
      },
      "outcomeMeasure": [
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          "name": "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia",
          "type": {
            "coding": [
              {
                "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
                "code": "primary",
                "display": "Primary"
              }
            ]
          },
          "description": "Percentage of participants who achieved treatment success during the controlled insulin-induced hypoglycemia in participants with type 1 diabetes mellitus (T1DM) and participants with type 2 diabetes mellitus (T2DM).Treatment success is defined as an increase in plasma glucose to greater than or equal to (≥) 70 milligrams per deciliter (mg/dL) or an increase of ≥20 mg/dL from plasma glucose nadir, without receiving additional actions to increase the plasma glucose concentration. Nadir is defined as the minimum plasma glucose concentration at the time of or within 10 minutes following glucagon administration.",
          "endpoint": {
            "reference": "EvidenceVariable/267226",
            "type": "EvidenceVariable",
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              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT03421379-primaryOutcome-0",
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              }
            },
            "display": "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia"
          }
        }
      ]
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            "system": "http://terminology.hl7.org/CodeSystem/research-study-objective-type",
            "code": "secondary",
            "display": "Secondary"
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        ]
      },
      "outcomeMeasure": [
        {
          "name": "Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)",
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            ]
          },
          "description": "PD assessment measured the change from Baseline in maximal blood glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride intramuscular (IM).",
          "endpoint": {
            "reference": "EvidenceVariable/267227",
            "type": "EvidenceVariable",
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                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT03421379-secondaryOutcome-0",
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              }
            },
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          }
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                "display": "Secondary"
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            ]
          },
          "description": "PD assessment measured the time to maximal concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM.",
          "endpoint": {
            "reference": "EvidenceVariable/267228",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT03421379-secondaryOutcome-1",
              "assigner": {
                "display": "Computable Publishing LLC"
              }
            },
            "display": "PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM"
          }
        },
        {
          "name": "Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM",
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                "display": "Secondary"
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            ]
          },
          "description": "PK assessment measured the change from baseline in the area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of Glucagon Nasal Powder and Glucagon Hydrochloride IM.",
          "endpoint": {
            "reference": "EvidenceVariable/267229",
            "type": "EvidenceVariable",
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                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT03421379-secondaryOutcome-2",
              "assigner": {
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              }
            },
            "display": "Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM"
          }
        },
        {
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          "type": {
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                "code": "secondary",
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              }
            ]
          },
          "description": "PK assessment measured the change from baseline in maximal concentration (Cmax) of glucagon nasal powder and glucagon hydrochloride IM.",
          "endpoint": {
            "reference": "EvidenceVariable/267230",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT03421379-secondaryOutcome-3",
              "assigner": {
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              }
            },
            "display": "PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM"
          }
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        {
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              }
            ]
          },
          "description": "PK assessment measured the change from baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM.",
          "endpoint": {
            "reference": "EvidenceVariable/267231",
            "type": "EvidenceVariable",
            "identifier": {
              "type": {
                "text": "FEvIR Linking Identifier"
              },
              "system": "https://fevir.net/FLI",
              "value": "NCT03421379-secondaryOutcome-4",
              "assigner": {
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              }
            },
            "display": "PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM"
          }
        }
      ]
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  "result": [
    {
      "reference": "Composition/267224",
      "type": "Composition",
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          "text": "FEvIR Linking Identifier"
        },
        "system": "https://fevir.net/FLI",
        "value": "NCT03421379 Results Report",
        "assigner": {
          "display": "Computable Publishing LLC"
        }
      },
      "display": "Results Section for NCT03421379"
    }
  ]
}