A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - Evidence Based Medicine on FHIR Implementation Guide v1.0.0-ballot2

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

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

version: 5; Last updated: 2025-09-14 18:30:51+0000

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, Other Identifier/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 ResearchStudy Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 267223. Revised 2025-09-14. 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/resources/Project/29885

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:

Location 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.
Location 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.
Location 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.
Location 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.

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., 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

ActualNumber

Eligibility

NCT03421379 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
- Name Type Description Endpoint
* Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia Primary
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.

EvidenceVariable Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia (NCT03421379)

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: EvidenceVariable Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) (NCT03421379)
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: EvidenceVariable PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)
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: EvidenceVariable 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 (NCT03421379)
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: EvidenceVariable PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)
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: EvidenceVariable PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)

result: Results Section for NCT03421379

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

Profile: VariableDefinition
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

Profile: VariableDefinition
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
- Code Value[x] Exclude
* Exposed to Drug: Glucagon Nasal Powder false

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
- Code Value[x] Exclude
* Exposed to Drug: Glucagon Hydrochloride Solution false

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
- Longitude Latitude
* 130.41667 33.6

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
- Longitude Latitude
* 139.69171 35.6895

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
- Longitude Latitude
* 139.69171 35.6895

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
- Longitude Latitude
* 139.69171 35.6895