Generated Narrative: ResearchStudy 267223 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 * 75 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
Computable Publishing®: [System]-to-FEvIR Converter
NCT03421379 Comparison Group: Glucagon Nasal Powder
A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally.
NCT03421379 Comparison Group: Glucagon Hydrochloride Solution
A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)
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.
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.
Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter
A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus
A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients With Diabetes Mellitus
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.
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.
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.
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: 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.
Oversight Classifier: oversightHasDmc False
Oversight Classifier: isFdaRegulatedDrug True
Oversight Classifier: isFdaRegulatedDevice False
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)
Glucagon Nasal Powder: A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally.
Glucagon Hydrochloride Solution: A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)
Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia
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.
Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)
PD assessment measured the change from Baseline in maximal blood glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride intramuscular (IM).
PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM
PD assessment measured the time to maximal concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM.
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
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.
PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM
PK assessment measured the change from baseline in maximal concentration (Cmax) of glucagon nasal powder and glucagon hydrochloride IM.
PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM
PK assessment measured the change from baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM.