Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
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
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ResearchStudy 267223</b></p><a name="267223"> </a><a name="hc267223"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 5; Last updated: 2025-09-14 18:30:51+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-study-registry-record.html">StudyRegistryRecord</a></p></div><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity registration-submission}">Registration submission</span></li><li>actual: true</li><li>period: 2018-01-30 --> (ongoing)</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity results-submission}">Results submission</span></li><li>actual: true</li><li>period: 2019-08-14 --> (ongoing)</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity registration-submission-qc}">Registration submission Quality Check</span></li><li>actual: true</li><li>period: 2018-01-30 --> (ongoing)</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity results-submission-qc}">Results submission Quality Check</span></li><li>actual: true</li><li>period: 2019-09-18 --> (ongoing)</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity record-verification}">Record Verification</span></li><li>actual: true</li><li>period: ?? --> 2019-09</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity update-submission}">Update submission</span></li><li>actual: true</li><li>period: ?? --> 2019-09-18</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity registration-posting}">Registration posting</span></li><li>actual: true</li><li>period: 2018-02-05 --> (ongoing)</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity results-posting}">Results posting</span></li><li>actual: true</li><li>period: 2019-10-08 --> (ongoing)</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity primary-outcome-data-collection}">Primary outcome data collection</span></li><li>actual: true</li><li>period: ?? --> 2018-08-20</li></ul></blockquote><blockquote><p><b>ResearchStudy Study Registration</b></p><ul><li>activity: <span title="Codes:{http://hl7.org/fhir/research-study-registration-activity update-posting}">Update posting</span></li><li>actual: true</li><li>period: ?? --> 2019-10-08</li></ul></blockquote><p><b>Artifact Author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><p><b>url</b>: <a href="https://fevir.net/resources/ResearchStudy/267223">https://fevir.net/resources/ResearchStudy/267223</a></p><p><b>identifier</b>: FEvIR Object Identifier/267223, <code>https://clinicaltrials.gov</code>/NCT03421379 (use: official, ), 16962, Other Identifier/I8R-JE-IGBJ, FEvIR Linking Identifier/NCT03421379 FHIR Transform</p><p><b>name</b>: NCT03421379_FHIR_Transform</p><p><b>title</b>: A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus</p><h3>Labels</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Value</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/title-type official}">Official title</span></td><td>A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients With Diabetes Mellitus</td></tr></table><p><b>citeAs</b>: </p><div><p>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.</p>
</div><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Transforms</p><p><b>target</b>: <a href="https://clinicaltrials.gov/api/v2/studies/NCT03421379?format=json">https://clinicaltrials.gov/api/v2/studies/NCT03421379?format=json</a></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Transformed With</p><p><b>target</b>: null @ https://fevir.net/resources/Project/29885</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Cites</p><p><b>target</b>: 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: <code>https://pubmed.ncbi.nlm.nih.gov</code>/38444629)</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Supported With</p><p><b>target</b>: null @ https://www.clinicalstudydatarequest.com</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Documentation</p><p><b>target</b>: application/pdf @ https://cdn.clinicaltrials.gov/large-docs/79/NCT03421379/Prot_000.pdf</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Documentation</p><p><b>target</b>: application/pdf @ https://cdn.clinicaltrials.gov/large-docs/79/NCT03421379/SAP_001.pdf</p></blockquote><p><b>status</b>: Active</p><p><b>primaryPurposeType</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type treatment}">Treatment</span></p><p><b>phase</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-phase phase-3}">Phase 3</span></p><p><b>studyDesign</b>: <span title="Codes:">Design Masking: None (Open Label)</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:01003}">randomized assignment</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:01012}">Crossover cohort design</span>, <span title="Codes:{https://fevir.net/sevco SEVCO:01001}">interventional research</span></p><p><b>condition</b>: <span title="Codes:">Diabetes Mellitus</span></p><p><b>descriptionSummary</b>: </p><div><p>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.</p>
</div><p><b>site</b>: </p><ul><li><a href="#hc267223/NCT03421379-Location-0">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.</a></li><li><a href="#hc267223/NCT03421379-Location-1">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.</a></li><li><a href="#hc267223/NCT03421379-Location-2">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.</a></li><li><a href="#hc267223/NCT03421379-Location-3">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.</a></li></ul><p><b>classifier</b>: <span title="Codes:">IPDSharing: Yes</span>, <span title="Codes:">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.</span>, <span title="Codes:">IPDSharingInfoType: Study Protocol</span>, <span title="Codes:">IPDSharingInfoType: Statistical Analysis Plan (SAP)</span>, <span title="Codes:">IPDSharingInfoType: Clinical Study Report (CSR)</span>, <span title="Codes:">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.</span>, <span title="Codes:">IPDSharingAccessCriteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</span>, <span title="Codes:">Has Results: True</span>, <span title="Codes:">Oversight Classifier: oversightHasDmc False</span>, <span title="Codes:">Oversight Classifier: isFdaRegulatedDrug True</span>, <span title="Codes:">Oversight Classifier: isFdaRegulatedDevice False</span>, <span title="Codes:">Oversight Classifier: isUsExport True</span>, <span title="Codes:">AgreementPISponsorEmployee: False</span>, <span title="Codes:">AgreementRestrictionType: GT60</span>, <span title="Codes:">AgreementRestrictiveAgreement: True</span></p><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Eli Lilly and Company</p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/research-study-party-role sponsor}">Sponsor</span></p><p><b>classifier</b>: <span title="Codes:">INDUSTRY</span></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: Eli Lilly and Company</p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/research-study-party-role lead-sponsor}">Lead sponsor</span></p><p><b>classifier</b>: <span title="Codes:">INDUSTRY</span></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>name</b>: 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)</p><p><b>role</b>: <span title="Codes:{http://hl7.org/fhir/research-study-party-role study-chair}">Study chair</span></p><p><b>party</b>: Eli Lilly and Company</p></blockquote><blockquote><p><b>progressStatus</b></p><p><b>state</b>: <span title="Codes:{http://hl7.org/fhir/research-study-status completed}">Completed</span></p></blockquote><blockquote><p><b>progressStatus</b></p><p><b>state</b>: <span title="Codes:{http://hl7.org/fhir/research-study-status overall-study}">Overall study</span></p><p><b>actual</b>: true</p><p><b>period</b>: 2018-02-21 --> 2018-08-20</p></blockquote><h3>Recruitments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ActualNumber</b></td><td><b>Eligibility</b></td></tr><tr><td style="display: none">*</td><td>75</td><td><a href="Group-267225.html">NCT03421379 Eligibility Criteria</a></td></tr></table><blockquote><p><b>comparisonGroup</b></p><p><b>eligibility</b>: <a href="#hc267223/NCT03421379-comparison-group-0">Glucagon Nasal Powder: A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally.</a></p></blockquote><blockquote><p><b>comparisonGroup</b></p><p><b>eligibility</b>: <a href="#hc267223/NCT03421379-comparison-group-1">Glucagon Hydrochloride Solution: A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)</a></p></blockquote><blockquote><p><b>objective</b></p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type primary}">Primary</span></p><h3>OutcomeMeasures</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Description</b></td><td><b>Endpoint</b></td></tr><tr><td style="display: none">*</td><td>Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia</td><td><span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type primary}">Primary</span></td><td><div><p>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.</p>
</div></td><td><a href="EvidenceVariable-267226.html">EvidenceVariable Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia (NCT03421379)</a></td></tr></table></blockquote><blockquote><p><b>objective</b></p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p><p><b>description</b>: </p><div><p>PD assessment measured the change from Baseline in maximal blood glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride intramuscular (IM).</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-267227.html">EvidenceVariable Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) (NCT03421379)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p><p><b>description</b>: </p><div><p>PD assessment measured the time to maximal concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM.</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-267228.html">EvidenceVariable PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: 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</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p><p><b>description</b>: </p><div><p>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.</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-267229.html">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)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p><p><b>description</b>: </p><div><p>PK assessment measured the change from baseline in maximal concentration (Cmax) of glucagon nasal powder and glucagon hydrochloride IM.</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-267230.html">EvidenceVariable PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)</a></p></blockquote><blockquote><p><b>outcomeMeasure</b></p><p><b>name</b>: PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/research-study-objective-type secondary}">Secondary</span></p><p><b>description</b>: </p><div><p>PK assessment measured the change from baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM.</p>
</div><p><b>endpoint</b>: <a href="EvidenceVariable-267231.html">EvidenceVariable PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)</a></p></blockquote></blockquote><p><b>result</b>: <a href="Composition-267224.html">Results Section for NCT03421379</a></p><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-drug------glucagon-nasal-powder</b></p><a name="267223/NCT03421379-drug------glucagon-nasal-powder"> </a><a name="hc267223/NCT03421379-drug------glucagon-nasal-powder"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>name</b>: NCT03421379_drug______glucagon_nasal_powder</p><p><b>title</b>: Glucagon Nasal Powder</p><p><b>status</b>: Active</p><p><b>description</b>: </p><div><p>Administered intranasally</p>
</div><p><b>note</b>: </p><blockquote><div><p>suggested alternative name: LY900018</p>
</div></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Intervention Type: DRUG</span></p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03421379-drug------glucagon-hydrochloride-solution</b></p><a name="267223/NCT03421379-drug------glucagon-hydrochloride-solution"> </a><a name="hc267223/NCT03421379-drug------glucagon-hydrochloride-solution"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>name</b>: NCT03421379_drug______glucagon_hydrochloride_solution</p><p><b>title</b>: Glucagon Hydrochloride Solution</p><p><b>status</b>: Active</p><p><b>description</b>: </p><div><p>Administered IM</p>
</div><p><b>note</b>: </p><blockquote><div><p>suggested alternative name: GlucaGen®</p>
</div></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Intervention Type: DRUG</span></p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Group #NCT03421379-comparison-group-0</b></p><a name="267223/NCT03421379-comparison-group-0"> </a><a name="hc267223/NCT03421379-comparison-group-0"> </a><p><b>Artifact Author</b>: Computable Publishing®: [System]-to-FEvIR Converter: </p><p><b>identifier</b>: FEvIR Linking Identifier/NCT03421379-comparison-group-0</p><p><b>title</b>: NCT03421379 Comparison Group: Glucagon Nasal Powder</p><p><b>status</b>: Active</p><p><b>description</b>: </p><div><p>A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally.</p>
</div><p><b>membership</b>: Conceptual</p><p><b>code</b>: <span title="Codes:">Experimental</span></p><h3>Characteristics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td><td><b>Exclude</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Exposed to</span></td><td><a href="#hc267223/NCT03421379-drug------glucagon-nasal-powder">Drug: Glucagon Nasal Powder</a></td><td>false</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Group #NCT03421379-comparison-group-1</b></p><a name="267223/NCT03421379-comparison-group-1"> </a><a name="hc267223/NCT03421379-comparison-group-1"> </a><p><b>Artifact Author</b>: Computable Publishing®: [System]-to-FEvIR Converter: </p><p><b>identifier</b>: FEvIR Linking Identifier/NCT03421379-comparison-group-1</p><p><b>title</b>: NCT03421379 Comparison Group: Glucagon Hydrochloride Solution</p><p><b>status</b>: Active</p><p><b>description</b>: </p><div><p>A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)</p>
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<role>
<coding>
<system value="http://hl7.org/fhir/research-study-party-role"/>
<code value="sponsor"/>
<display value="Sponsor"/>
</coding>
</role>
<classifier>
<text value="INDUSTRY"/>
</classifier>
</associatedParty>
<associatedParty>
<name value="Eli Lilly and Company"/>
<role>
<coding>
<system value="http://hl7.org/fhir/research-study-party-role"/>
<code value="lead-sponsor"/>
<display value="Lead sponsor"/>
</coding>
</role>
<classifier>
<text value="INDUSTRY"/>
</classifier>
</associatedParty>
<associatedParty>
<name
value="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 value="http://hl7.org/fhir/research-study-party-role"/>
<code value="study-chair"/>
<display value="Study chair"/>
</coding>
</role>
<party>
<display value="Eli Lilly and Company"/>
</party>
</associatedParty>
<progressStatus>
<state>
<coding>
<system value="http://hl7.org/fhir/research-study-status"/>
<code value="completed"/>
<display value="Completed"/>
</coding>
</state>
</progressStatus>
<progressStatus>
<state>
<coding>
<system value="http://hl7.org/fhir/research-study-status"/>
<code value="overall-study"/>
<display value="Overall study"/>
</coding>
</state>
<actual value="true"/>
<period>
<start value="2018-02-21"/>
<end value="2018-08-20"/>
</period>
</progressStatus>
<recruitment>
<actualNumber value="75"/>
<eligibility>🔗
<reference value="Group/267225"/>
<type value="Group"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03421379 Eligibility Criteria"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="NCT03421379 Eligibility Criteria"/>
</eligibility>
</recruitment>
<comparisonGroup>
<eligibility>
<reference value="#NCT03421379-comparison-group-0"/>
<type value="Group"/>
<display
value="Glucagon Nasal Powder: A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally."/>
</eligibility>
</comparisonGroup>
<comparisonGroup>
<eligibility>
<reference value="#NCT03421379-comparison-group-1"/>
<type value="Group"/>
<display
value="Glucagon Hydrochloride Solution: A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)"/>
</eligibility>
</comparisonGroup>
<objective>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="primary"/>
<display value="Primary"/>
</coding>
</type>
<outcomeMeasure>
<name
value="Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="primary"/>
<display value="Primary"/>
</coding>
</type>
<description
value="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 value="EvidenceVariable/267226"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03421379-primaryOutcome-0"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
</objective>
<objective>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<outcomeMeasure>
<name
value="Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description
value="PD assessment measured the change from Baseline in maximal blood glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride intramuscular (IM)."/>
<endpoint>🔗
<reference value="EvidenceVariable/267227"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03421379-secondaryOutcome-0"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name
value="PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description
value="PD assessment measured the time to maximal concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM."/>
<endpoint>🔗
<reference value="EvidenceVariable/267228"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03421379-secondaryOutcome-1"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name
value="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
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description
value="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 value="EvidenceVariable/267229"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03421379-secondaryOutcome-2"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name
value="PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description
value="PK assessment measured the change from baseline in maximal concentration (Cmax) of glucagon nasal powder and glucagon hydrochloride IM."/>
<endpoint>🔗
<reference value="EvidenceVariable/267230"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03421379-secondaryOutcome-3"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
<outcomeMeasure>
<name
value="PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description
value="PK assessment measured the change from baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM."/>
<endpoint>🔗
<reference value="EvidenceVariable/267231"/>
<type value="EvidenceVariable"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03421379-secondaryOutcome-4"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
</endpoint>
</outcomeMeasure>
</objective>
<result>🔗
<reference value="Composition/267224"/>
<type value="Composition"/>
<identifier>
<type>
<text value="FEvIR Linking Identifier"/>
</type>
<system value="https://fevir.net/FLI"/>
<value value="NCT03421379 Results Report"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<display value="Results Section for NCT03421379"/>
</result>
</ResearchStudy>
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot2 based on FHIR 6.0.0-ballot3. Generated 2025-11-05
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