http://hl7.org/fhir/uv/ebm/ResearchStudy/267223
type: ResearchStudy
node role: treeRoot
id:
  v: 267223
meta:
  version id:
    v: 10
  last updated:
    v: 2025-12-11T20:35:21.032Z
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/study-registry-record
    l: study-registry-record
language:
  v: en
text:
  status:
    v: extensions
  div:
    v: 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 - Type Value * Official title 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 ResearchStud…
contained: EvidenceVariable
  id:
    v: NCT03421379-drug------glucagon-nasal-powder
  meta:
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
      l: variable-definition
  name:
    v: NCT03421379_drug______glucagon_nasal_powder
  title:
    v: Glucagon Nasal Powder
  status:
    v: active
  description:
    v: Administered intranasally
  note:
    text:
      v: suggested alternative name: LY900018
  handling:
    v: boolean
  classifier:
    text:
      v: Intervention Type: DRUG
contained: EvidenceVariable
  id:
    v: NCT03421379-drug------glucagon-hydrochloride-solution
  meta:
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
      l: variable-definition
  name:
    v: NCT03421379_drug______glucagon_hydrochloride_solution
  title:
    v: Glucagon Hydrochloride Solution
  status:
    v: active
  description:
    v: Administered IM
  note:
    text:
      v: suggested alternative name: GlucaGen®
  handling:
    v: boolean
  classifier:
    text:
      v: Intervention Type: DRUG
contained: Group
  id:
    v: NCT03421379-comparison-group-0
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/artifact-author
      l: artifact-author
    value: ContactDetail
      name:
        v: Computable Publishing®: [System]-to-FEvIR Converter
  identifier:
    type:
      text:
        v: FEvIR Linking Identifier
    system:
      v: https://fevir.net/FLI
      l: FLI
    value:
      v: NCT03421379-comparison-group-0
    assigner:
      display:
        v: Computable Publishing LLC
  title:
    v: NCT03421379 Comparison Group: Glucagon Nasal Powder
  status:
    v: active
  description:
    v: A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally.
  membership:
    v: conceptual
  code:
    text:
      v: Experimental
  characteristic:
    code:
      text:
        v: Exposed to
    value: Reference
      l: NCT03421379-drug------glucagon-nasal-powder
      reference:
        v: #NCT03421379-drug------glucagon-nasal-powder
      type:
        v: EvidenceVariable
        l: EvidenceVariable
      display:
        v: Drug: Glucagon Nasal Powder
    exclude:
      v: false
contained: Group
  id:
    v: NCT03421379-comparison-group-1
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/artifact-author
      l: artifact-author
    value: ContactDetail
      name:
        v: Computable Publishing®: [System]-to-FEvIR Converter
  identifier:
    type:
      text:
        v: FEvIR Linking Identifier
    system:
      v: https://fevir.net/FLI
      l: FLI
    value:
      v: NCT03421379-comparison-group-1
    assigner:
      display:
        v: Computable Publishing LLC
  title:
    v: NCT03421379 Comparison Group: Glucagon Hydrochloride Solution
  status:
    v: active
  description:
    v: A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)
  membership:
    v: conceptual
  code:
    text:
      v: Active Comparator
  characteristic:
    code:
      text:
        v: Exposed to
    value: Reference
      l: NCT03421379-drug------glucagon-hydrochloride-solution
      reference:
        v: #NCT03421379-drug------glucagon-hydrochloride-solution
      type:
        v: EvidenceVariable
        l: EvidenceVariable
      display:
        v: Drug: Glucagon Hydrochloride Solution
    exclude:
      v: false
contained: Location
  id:
    v: NCT03421379-Location-0
  name:
    v: 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:
    city:
      v: Fukuoka
    postal code:
      v: 812-0025
    country:
      v: Japan
  position:
    longitude:
      v: 130.41667
    latitude:
      v: 33.6
contained: Location
  id:
    v: NCT03421379-Location-1
  name:
    v: 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:
    city:
      v: Tokyo
    postal code:
      v: 130-0004
    country:
      v: Japan
  position:
    longitude:
      v: 139.69171
    latitude:
      v: 35.6895
contained: Location
  id:
    v: NCT03421379-Location-2
  name:
    v: 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:
    city:
      v: Tokyo

v: 162-0053

v: Japan

longitude:
  v: 139.69171
latitude:
  v: 35.6895

Location
id:
  v: NCT03421379-Location-3
name:
  v: 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:
  city:
    v: Tokyo
  postal code:
    v: 169-0073
  country:
    v: Japan
position:
  longitude:
    v: 139.69171
  latitude:
    v: 35.6895

extension:
  url:
    v: activity
    l: activity
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/research-study-registration-activity
        l: research-study-registration-activity
      code:
        v: registration-submission
      display:
        v: Registration submission
extension:
  url:
    v: actual
    l: actual
  value: Boolean
    v: true
extension:
  url:
    v: period
    l: period
  value: Period
    start:
      v: 2018-01-30
url:
  v: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration
  l: researchStudy-studyRegistration

extension:
  url:
    v: activity
    l: activity
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/research-study-registration-activity
        l: research-study-registration-activity
      code:
        v: results-submission
      display:
        v: Results submission
extension:
  url:
    v: actual
    l: actual
  value: Boolean
    v: true
extension:
  url:
    v: period
    l: period
  value: Period
    start:
      v: 2019-08-14
url:
  v: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration
  l: researchStudy-studyRegistration

extension:
  url:
    v: activity
    l: activity
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/research-study-registration-activity
        l: research-study-registration-activity
      code:
        v: registration-submission-qc
      display:
        v: Registration submission Quality Check
extension:
  url:
    v: actual
    l: actual
  value: Boolean
    v: true
extension:
  url:
    v: period
    l: period
  value: Period
    start:
      v: 2018-01-30
url:
  v: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration
  l: researchStudy-studyRegistration

extension:
  url:
    v: activity
    l: activity
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/research-study-registration-activity
        l: research-study-registration-activity
      code:
        v: results-submission-qc
      display:
        v: Results submission Quality Check
extension:
  url:
    v: actual
    l: actual
  value: Boolean
    v: true
extension:
  url:
    v: period
    l: period
  value: Period
    start:
      v: 2019-09-18
url:
  v: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration
  l: researchStudy-studyRegistration

extension:
  url:
    v: activity
    l: activity
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/research-study-registration-activity
        l: research-study-registration-activity
      code:
        v: record-verification
      display:
        v: Record Verification
extension:
  url:
    v: actual
    l: actual
  value: Boolean
    v: true
extension:
  url:
    v: period
    l: period
  value: Period
    end:
      v: 2019-09
url:
  v: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration
  l: researchStudy-studyRegistration

extension:
  url:
    v: activity
    l: activity
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/research-study-registration-activity
        l: research-study-registration-activity
      code:
        v: update-submission
      display:
        v: Update submission
extension:
  url:
    v: actual
    l: actual
  value: Boolean
    v: true
extension:
  url:
    v: period
    l: period
  value: Period
    end:
      v: 2019-09-18
url:
  v: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration
  l: researchStudy-studyRegistration

extension:
  url:
    v: activity
    l: activity
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/research-study-registration-activity
        l: research-study-registration-activity
      code:
        v: registration-posting
      display:
        v: Registration posting
extension:
  url:
    v: actual
    l: actual
  value: Boolean
    v: true
extension:
  url:
    v: period
    l: period
  value: Period
    start:
      v: 2018-02-05
url:
  v: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration
  l: researchStudy-studyRegistration

extension:
  url:
    v: activity
    l: activity
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/research-study-registration-activity
        l: research-study-registration-activity
      code:
        v: results-posting
      display:
        v: Results posting
extension:
  url:
    v: actual
    l: actual
  value: Boolean
    v: true
extension:
  url:
    v: period
    l: period
  value: Period
    start:
      v: 2019-10-08
url:
  v: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration
  l: researchStudy-studyRegistration

extension:
  url:
    v: activity
    l: activity
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/research-study-registration-activity
        l: research-study-registration-activity
      code:
        v: primary-outcome-data-collection
      display:
        v: Primary outcome data collection
extension:
  url:
    v: actual
    l: actual
  value: Boolean
    v: true
extension:
  url:
    v: period
    l: period
  value: Period
    end:
      v: 2018-08-20
url:
  v: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration
  l: researchStudy-studyRegistration

extension:
  url:
    v: activity
    l: activity
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/research-study-registration-activity
        l: research-study-registration-activity
      code:
        v: update-posting
      display:
        v: Update posting
extension:
  url:
    v: actual
    l: actual
  value: Boolean
    v: true
extension:
  url:
    v: period
    l: period
  value: Period
    end:
      v: 2019-10-08
url:
  v: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration
  l: researchStudy-studyRegistration

url:
  v: http://hl7.org/fhir/StructureDefinition/artifact-author
  l: artifact-author
value: ContactDetail
  name:
    v: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter

type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0203
      l: v2-0203
    code:
      v: ACSN
    display:
      v: Accession ID
  text:
    v: FEvIR Object Identifier
system:
  v: https://fevir.net/FOI
  l: FOI
value:
  v: 267223
assigner:
  display:
    v: Computable Publishing LLC

use:
  v: official
system:
  v: https://clinicaltrials.gov
  l: clinicaltrials.gov
value:
  v: NCT03421379

value:
  v: 16962
assigner:
  display:
    v: Eli Lilly and Company

value:
  v: I8R-JE-IGBJ
assigner:
  display:
    v: Eli Lilly and Company

type:
  text:
    v: FEvIR Linking Identifier
system:
  v: https://fevir.net/FLI
  l: FLI
value:
  v: NCT03421379 FHIR Transform
assigner:
  display:
    v: Computable Publishing LLC

v: NCT03421379_FHIR_Transform

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

type:
  coding:
    system:
      v: http://hl7.org/fhir/title-type
      l: title-type
    code:
      v: official
    display:
      v: Official title
value:
  v: A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients With Diabetes Mellitus

v: 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.

type:
  v: transforms
target: Uri
  v: https://clinicaltrials.gov/api/v2/studies/NCT03421379
  l: https://clinicaltrials.gov/api/v2/studies/NCT03421379

type:
  v: transformed-with
target: Attachment
  url:
    v: https://fevir.net/ctgovconvert
    l: ctgovconvert
  title:
    v: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter

type:
  v: cites
target: Reference
  type:
    v: Citation
    l: Citation
  identifier:
    system:
      v: https://pubmed.ncbi.nlm.nih.gov
      l: pubmed.ncbi.nlm.nih.gov
    value:
      v: 38444629
  display:
    v: 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:
  v: supported-with
target: Attachment
  url:
    v: https://www.clinicalstudydatarequest.com
    l: www.clinicalstudydatarequest.com
  title:
    v: IPD Sharing URL

type:
  v: documentation
target: Attachment
  content type:
    v: application/pdf
  url:
    v: https://cdn.clinicaltrials.gov/large-docs/79/NCT03421379/Prot_000.pdf
    l: Prot 000.pdf
  size:
    v: 684592
  title:
    v: ProtStudy Protocol
  creation:
    v: 2017-12-05

type:
  v: documentation
target: Attachment
  content type:
    v: application/pdf
  url:
    v: https://cdn.clinicaltrials.gov/large-docs/79/NCT03421379/SAP_001.pdf
    l: SAP 001.pdf
  size:
    v: 444216
  title:
    v: SAPStatistical Analysis Plan
  creation:
    v: 2018-02-02

v: active

coding:
  system:
    v: http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type
    l: research-study-prim-purp-type
  code:
    v: treatment
  display:
    v: Treatment

coding:
  system:
    v: http://terminology.hl7.org/CodeSystem/research-study-phase
    l: research-study-phase
  code:
    v: phase-3
  display:
    v: Phase 3

text:
  v: Design Masking: None (Open Label)

coding:
  system:
    v: https://fevir.net/sevco
    l: sevco
  code:
    v: SEVCO:01003
  display:
    v: randomized assignment

coding:
  system:
    v: https://fevir.net/sevco
    l: sevco
  code:
    v: SEVCO:01012
  display:
    v: Crossover cohort design

coding:
  system:
    v: https://fevir.net/sevco
    l: sevco
  code:
    v: SEVCO:01001
  display:
    v: interventional research

text:
  v: Diabetes Mellitus

v: 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.

l: NCT03421379-Location-0
reference:
  v: #NCT03421379-Location-0
type:
  v: Location
  l: Location

l: NCT03421379-Location-1
reference:
  v: #NCT03421379-Location-1
type:
  v: Location
  l: Location

l: NCT03421379-Location-2
reference:
  v: #NCT03421379-Location-2
type:
  v: Location
  l: Location

l: NCT03421379-Location-3
reference:
  v: #NCT03421379-Location-3
type:
  v: Location
  l: Location

text:
  v: IPDSharing: Yes

text:
  v: 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:
  v: IPDSharingInfoType: Study Protocol

text:
  v: IPDSharingInfoType: Statistical Analysis Plan (SAP)

text:
  v: IPDSharingInfoType: Clinical Study Report (CSR)

text:
  v: 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:
  v: IPDSharingAccessCriteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

text:
  v: Does Not Accept Healthy Volunteers

text:
  v: Minimum Age: 18 Years

text:
  v: Maximum Age: 70 Years

text:
  v: Age Group: Adult

text:
  v: Age Group: Older Adult

text:
  v: Has Results: True

text:
  v: Oversight Classifier: oversightHasDmc False

text:
  v: Oversight Classifier: isFdaRegulatedDrug True

text:
  v: Oversight Classifier: isFdaRegulatedDevice False

text:
  v: Oversight Classifier: isUsExport True

text:
  v: AgreementPISponsorEmployee: False

text:
  v: AgreementRestrictionType: GT60

text:
  v: AgreementRestrictiveAgreement: True

name:
  v: Eli Lilly and Company
role:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/research-study-party-role
      l: research-study-party-role
    code:
      v: sponsor
    display:
      v: Sponsor
classifier:
  text:
    v: INDUSTRY

name:
  v: Eli Lilly and Company
role:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/research-study-party-role
      l: research-study-party-role
    code:
      v: lead-sponsor
    display:
      v: Lead sponsor
classifier:
  text:
    v: INDUSTRY

name:
  v: 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:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/research-study-party-role
      l: research-study-party-role
    code:
      v: study-chair
    display:
      v: Study chair
party:
  display:
    v: Eli Lilly and Company

state:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/research-study-status
      l: research-study-status
    code:
      v: completed
    display:
      v: Completed

state:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/research-study-status
      l: research-study-status
    code:
      v: overall-study
    display:
      v: Overall study
actual:
  v: true
period:
  start:
    v: 2018-02-21
  end:
    v: 2018-08-20

actual number:
  v: 75
eligibility:
  l: http://hl7.org/fhir/uv/ebm/Group/267225
  reference:
    v: Group/267225
  type:
    v: Group
    l: Group
  identifier:
    type:
      text:
        v: FEvIR Linking Identifier
    system:
      v: https://fevir.net/FLI
      l: FLI
    value:
      v: NCT03421379 Eligibility Criteria
    assigner:
      display:
        v: Computable Publishing LLC
  display:
    v: NCT03421379 Eligibility Criteria

eligibility:
  l: NCT03421379-comparison-group-0
  reference:
    v: #NCT03421379-comparison-group-0
  type:
    v: Group
    l: Group
  display:
    v: Glucagon Nasal Powder: A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally.

eligibility:
  l: NCT03421379-comparison-group-1
  reference:
    v: #NCT03421379-comparison-group-1
  type:
    v: Group
    l: Group
  display:
    v: Glucagon Hydrochloride Solution: A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)

type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
      l: research-study-objective-type
    code:
      v: primary
    display:
      v: Primary
outcome measure:
  name:
    v: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: primary
      display:
        v: Primary
  description:
    v: 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:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/267226
    reference:
      v: EvidenceVariable/267226
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03421379-primaryOutcome-0
    display:
      v: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia

v: FEvIR Linking Identifier

v: Computable Publishing LLC

type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
      l: research-study-objective-type
    code:
      v: secondary
    display:
      v: Secondary
outcome measure:
  name:
    v: Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: secondary
      display:
        v: Secondary
  description:
    v: PD assessment measured the change from Baseline in maximal blood glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride intramuscular (IM).
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/267227
    reference:
      v: EvidenceVariable/267227
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03421379-secondaryOutcome-0
    display:
      v: Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)
outcome measure:
  name:
    v: PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: secondary
      display:
        v: Secondary
  description:
    v: PD assessment measured the time to maximal concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM.
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/267228
    reference:
      v: EvidenceVariable/267228
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03421379-secondaryOutcome-1
    display:
      v: PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM
outcome measure:
  name:
    v: 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:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: secondary
      display:
        v: Secondary
  description:
    v: 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:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/267229
    reference:
      v: EvidenceVariable/267229
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03421379-secondaryOutcome-2
    display:
      v: 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
outcome measure:
  name:
    v: PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: secondary
      display:
        v: Secondary
  description:
    v: PK assessment measured the change from baseline in maximal concentration (Cmax) of glucagon nasal powder and glucagon hydrochloride IM.
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/267230
    reference:
      v: EvidenceVariable/267230
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03421379-secondaryOutcome-3
    display:
      v: PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM
outcome measure:
  name:
    v: PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/research-study-objective-type
        l: research-study-objective-type
      code:
        v: secondary
      display:
        v: Secondary
  description:
    v: PK assessment measured the change from baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM.
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/267231
    reference:
      v: EvidenceVariable/267231
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03421379-secondaryOutcome-4
    display:
      v: PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

l: http://hl7.org/fhir/uv/ebm/Composition/267224
reference:
  v: Composition/267224
type:
  v: Composition
  l: Composition
identifier:
  type:
    text:
      v: FEvIR Linking Identifier
  system:
    v: https://fevir.net/FLI
    l: FLI
  value:
    v: NCT03421379 Results Report
  assigner:
    display:
      v: Computable Publishing LLC
display:
  v: Results Section for NCT03421379