Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - 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 2.0.0-ballot 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
<ResearchStudy xmlns="http://hl7.org/fhir">
<id value="267245"/>
<meta>
<versionId value="48"/>
<lastUpdated value="2024-09-03T18:34:08.592Z"/>
<profile
value="http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-research-study"/>
</meta>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[No data.]</div>
</text>
<contained>
<EvidenceVariable>
<id value="NCT03421379-drug------glucagon-nasal-powder"/>
<name value="NCT03421379_drug______glucagon_nasal_powder"/>
<title value="Glucagon Nasal Powder"/>
<status value="active"/>
<description value="Administered intranasally"/>
<note>
<text value="suggested alternative name: LY900018"/>
</note>
<useContext>
<code>
<system
value="https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-InterventionType"/>
<code value="interventionType"/>
<display value="Intervention Type for ClinicalTrials.gov"/>
</code>
<valueCodeableConcept>
<text value="DRUG"/>
</valueCodeableConcept>
</useContext>
</EvidenceVariable>
</contained>
<contained>
<EvidenceVariable>
<id value="NCT03421379-drug------glucagon-hydrochloride-solution"/>
<name value="NCT03421379_drug______glucagon_hydrochloride_solution"/>
<title value="Glucagon Hydrochloride Solution"/>
<status value="active"/>
<description value="Administered IM"/>
<note>
<text value="suggested alternative name: GlucaGen®"/>
</note>
<useContext>
<code>
<system
value="https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-InterventionType"/>
<code value="interventionType"/>
<display value="Intervention Type for ClinicalTrials.gov"/>
</code>
<valueCodeableConcept>
<text value="DRUG"/>
</valueCodeableConcept>
</useContext>
</EvidenceVariable>
</contained>
<contained>
<Location>
<id value="NCT03421379-Location-0"/>
<name
value="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 value="Fukuoka"/>
<postalCode value="812-0025"/>
<country value="Japan"/>
</address>
<position>
<longitude value="130.41667"/>
<latitude value="33.6"/>
</position>
</Location>
</contained>
<contained>
<Location>
<id value="NCT03421379-Location-1"/>
<name
value="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 value="Tokyo"/>
<postalCode value="130-0004"/>
<country value="Japan"/>
</address>
<position>
<longitude value="139.69171"/>
<latitude value="35.6895"/>
</position>
</Location>
</contained>
<contained>
<Location>
<id value="NCT03421379-Location-2"/>
<name
value="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 value="Tokyo"/>
<postalCode value="162-0053"/>
<country value="Japan"/>
</address>
<position>
<longitude value="139.69171"/>
<latitude value="35.6895"/>
</position>
</Location>
</contained>
<contained>
<Location>
<id value="NCT03421379-Location-3"/>
<name
value="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 value="Tokyo"/>
<postalCode value="169-0073"/>
<country value="Japan"/>
</address>
<position>
<longitude value="139.69171"/>
<latitude value="35.6895"/>
</position>
</Location>
</contained>
<extension url="http://hl7.org/fhir/StructureDefinition/artifact-author">
<valueContactDetail>
<name
value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/>
</valueContactDetail>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/artifact-author">
<valueContactDetail>
<name value="Brian S. Alper"/>
</valueContactDetail>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sponsor-confidentiality-statement">
<valueString
value="This study does not have a confidentiality statement, but this is an example of how the data would appear if there was such a statement."/>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sae-reporting-method">
<valueString
value="Report Serious Adverse Events to the sponsor by phone. Refer to Section 9.4 for detailed reporting instructions."/>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment">
<extension url="details">
<valueString value="This protocol has not been amended previously."/>
</extension>
<extension url="description">
<valueString
value="Protocol I8R-JE-IGBJ A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with Diabetes Mellitus has been amended. The new protocol is indicated by Amendment (a) and will be used to conduct the study in place of any preceding version of the protocol. The overall changes and rationale for the changes made to this protocol are as follows: (1) An exclusion criterion for patients with retinopathy or maculopathy was added due to the potential risk of fundal hemorrhage induced by hypoglycemia. (2) The GlucaGen reconstitution volume was changed from 1.0 mL to 1.1 mL in accordance with instructions in the Summary of Product Characteristics (2015)."/>
</extension>
<extension url="rationale">
<valueString
value="Updates to address safety concern & align with product guidelines."/>
</extension>
<extension url="substantialImpactSafety">
<valueBoolean value="true"/>
</extension>
<extension url="substantialImpactSafetyComment">
<valueString
value="Specifically implemented to decrease safety risks."/>
</extension>
<extension url="substantialImpactReliability">
<valueBoolean value="false"/>
</extension>
<extension url="primaryReason">
<valueCodeableConcept>
<coding>
<system value="http://spor.ema.europa.eu/v1/example-reason"/>
<code value="2"/>
<display value="Safety"/>
</coding>
<text value="Safety"/>
</valueCodeableConcept>
</extension>
</extension>
<url value="https://fevir.net/resources/ResearchStudy/267245"/>
<identifier>
<type>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
<code value="ACSN"/>
<display value="Accession ID"/>
</coding>
<text value="FEvIR Object Identifier"/>
</type>
<system value="https://fevir.net"/>
<value value="267245"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<identifier>
<use value="official"/>
<system value="https://clinicaltrials.gov"/>
<value value="NCT03421379"/>
</identifier>
<identifier>
<value value="16962"/>
<assigner>
<display value="Eli Lilly and Company"/>
</assigner>
</identifier>
<identifier>
<type>
<text value="Sponsor Protocol Identifier"/>
</type>
<value value="I8R-JE-IGBJ"/>
<assigner>
<display value="Eli Lilly and Company"/>
</assigner>
</identifier>
<identifier>
<type>
<text value="Amendment Identifier"/>
</type>
<value value="I8R-JE-IGBJ(a)"/>
</identifier>
<version value="(a)"/>
<name value="NCT03421379_FHIR_Transform_M11_IGBJ"/>
<title
value="A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example"/>
<label>
<type>
<coding>
<system value="http://hl7.org/fhir/title-type"/>
<code value="official"/>
<display value="Official title"/>
</coding>
</type>
<value
value="A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients With Diabetes Mellitus"/>
</label>
<label>
<type>
<coding>
<system value="http://hl7.org/fhir/title-type"/>
<code value="acronym"/>
<display value="Acronym"/>
</coding>
</type>
<value value="IGBJ"/>
</label>
<label>
<type>
<coding>
<system value="http://hl7.org/fhir/title-type"/>
<code value="short-title"/>
<display value="Short title"/>
</coding>
</type>
<value value="M11 IGBJ EXAMPLE"/>
</label>
<relatedArtifact>
<type value="transforms"/>
<document>
<url
value="https://clinicaltrials.gov/api/v2/studies/NCT03421379?format=json"/>
</document>
</relatedArtifact>
<relatedArtifact>
<type value="transformed-with"/>
<display
value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/>
<document>
<url value="https://fevir.net/resources/Project/29885"/>
</document>
</relatedArtifact>
<relatedArtifact>
<type value="supported-with"/>
<classifier>
<text value="IPD Sharing URL"/>
</classifier>
<document>
<url value="https://www.clinicalstudydatarequest.com"/>
</document>
</relatedArtifact>
<relatedArtifact>
<type value="documentation"/>
<classifier>
<text value="Prot"/>
</classifier>
<label value="Study Protocol"/>
<document>
<contentType value="application/pdf"/>
<url
value="https://cdn.clinicaltrials.gov/large-docs/79/NCT03421379/Prot_000.pdf"/>
<size value="684592"/>
<creation value="2017-12-05"/>
</document>
</relatedArtifact>
<relatedArtifact>
<type value="documentation"/>
<classifier>
<text value="SAP"/>
</classifier>
<label value="Statistical Analysis Plan"/>
<document>
<contentType value="application/pdf"/>
<url
value="https://cdn.clinicaltrials.gov/large-docs/79/NCT03421379/SAP_001.pdf"/>
<size value="444216"/>
<creation value="2018-02-02"/>
</document>
</relatedArtifact>
<relatedArtifact>
<type value="cites"/>
<citation
value="American Diabetes Association; Workgroup on Hypoglycemia. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005;28(5):1245-1249."/>
<resourceReference>🔗
<reference value="Citation/267496"/>
<type value="Citation"/>
<display
value="Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia."/>
</resourceReference>
</relatedArtifact>
<relatedArtifact>
<type value="cites"/>
<citation
value="American Diabetes Association. Glycemic targets. Diabetes Care. 2017;40(suppl 1):S48-S56."/>
<resourceReference>🔗
<reference value="Citation/267497"/>
<type value="Citation"/>
<display value="6. Glycemic Targets."/>
</resourceReference>
</relatedArtifact>
<relatedArtifact>
<type value="cites"/>
<citation
value="GlucaGen (glucagon [rDNA origin] for injection) [Summary of Product Characteristics]. Bagsvaerd, Denmark: Novo Nordisk; revised 2015. Available at: https://www.medicines.org.uk/emc/medicine/4258#DOCREVISION. Accessed September 29, 2017."/>
<document>
<url
value="https://www.medicines.org.uk/emc/medicine/4258#DOCREVISION"/>
</document>
</relatedArtifact>
<relatedArtifact>
<type value="cites"/>
<citation
value="Glucagon G Novo for Injection [Package Insert]. Bagsvaerd, Denmark: Novo Nordisk; revised 2016. Available at: http://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/620023_7229402D1036_1_06. Accessed September 28, 2017."/>
</relatedArtifact>
<relatedArtifact>
<type value="cites"/>
<citation
value="Glucagon G Novo for Injection [Interview Form]. Bagsvaerd, Denmark: Novo Nordisk; 2015. Available at: http://www.info.pmda.go.jp/go/interview/1/620023_7229402D1036_1_007_1F. Accessed September 28, 2017."/>
</relatedArtifact>
<relatedArtifact>
<type value="cites"/>
<citation
value="GLUCAGON for Injection ITO [Package Insert]. Osaka, Japan: Kaigen Pharma Co., Ltd; 2016. Available at: http://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/130616_7229400D1088_1_11."/>
</relatedArtifact>
<relatedArtifact>
<type value="cites"/>
<citation
value="GLUCAGON for Injection ITO [Interview Form]. Osaka, Japan: Kaigen Pharma Co., Ltd; 2016. Available at: http://www.info.pmda.go.jp/go/interview/1/130616_7229400D1088_1_G07_1F. Accessed September 28, 2017."/>
</relatedArtifact>
<relatedArtifact>
<type value="cites"/>
<citation
value="Polonsky WH, Fisher L, Hessler D, Johnson N. Emotional distress in the partners of type 1 diabetes adults: worries about hypoglycemia and other key concerns. Diabetes Technol Ther. 2016;18:292-297."/>
<resourceReference>🔗
<reference value="Citation/267498"/>
<type value="Citation"/>
<display
value="Emotional Distress in the Partners of Type 1 Diabetes Adults: Worries About Hypoglycemia and Other Key Concerns."/>
</resourceReference>
</relatedArtifact>
<relatedArtifact>
<type value="cites"/>
<citation
value="Rickels MR, Ruedy KJ, Foster NC, Piché CA, Dulude H, Sherr JL, Tamborlane WV, Bethin KE, DiMeglio LA, Wadwa RP, Ahmann AJ, Haller MJ, Nathan BM, Marcovina SM, Rampakakis E, Meng L, Beck RW; T1D Exchange Intranasal Glucagon Investigators. Intranasal glucagon for treatment of insulin-induced hypoglycemia in adults with type 1 diabetes: a randomized crossover noninferiority study. Diabetes Care. 2016;39(2):264-270."/>
<resourceReference>🔗
<reference value="Citation/267499"/>
<type value="Citation"/>
<display
value="Intranasal Glucagon for Treatment of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes: A Randomized Crossover Noninferiority Study."/>
</resourceReference>
</relatedArtifact>
<relatedArtifact>
<type value="cites"/>
<citation
value="Reno FE, Normand P, McInally K, Silo S, Stotland P, Triest M, Carballo D, Piché C. A novel nasal powder formulation of glucagon: toxicology studies in animal models. BMC Pharmacol Toxicol. 2015;16:29."/>
<resourceReference>🔗
<reference value="Citation/267500"/>
<type value="Citation"/>
<display
value="A novel nasal powder formulation of glucagon: toxicology studies in animal models."/>
</resourceReference>
</relatedArtifact>
<relatedArtifact>
<type value="cites"/>
<citation
value="Seaquist ER, Anderson J, Childs B, Cryer P, Dagogo-Jack S, Fish L, Heller SR, Rodriguez H, Rosenzweig J, Vigersky R. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013;36(5):1384-1395"/>
<resourceReference>🔗
<reference value="Citation/267501"/>
<type value="Citation"/>
<display
value="23589542 Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society."/>
</resourceReference>
</relatedArtifact>
<status value="active"/>
<primaryPurposeType>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type"/>
<code value="treatment"/>
<display value="Treatment"/>
</coding>
</primaryPurposeType>
<phase>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/research-study-phase"/>
<code value="phase-3"/>
<display value="Phase 3"/>
</coding>
</phase>
<studyDesign>
<text value="Design Masking: None (Open Label)"/>
</studyDesign>
<studyDesign>
<coding>
<system value="http://hl7.org/fhir/study-design"/>
<code value="SEVCO:01003"/>
<display value="randomized assignment"/>
</coding>
</studyDesign>
<studyDesign>
<coding>
<system value="http://hl7.org/fhir/study-design"/>
<code value="SEVCO:01012"/>
<display value="Crossover cohort design"/>
</coding>
</studyDesign>
<studyDesign>
<coding>
<system value="http://hl7.org/fhir/study-design"/>
<code value="SEVCO:01001"/>
<display value="interventional research"/>
</coding>
</studyDesign>
<focus>
<concept>
<coding>
<system value="http://example.org"/>
<code value="LY900018"/>
<display value="Glucagon"/>
</coding>
</concept>
<reference>
<type value="SubstanceDefinition"/>
<display value="Glucagon (LY900018)"/>
</reference>
</focus>
<condition>
<text value="Diabetes Mellitus"/>
</condition>
<condition>
<text value="insulin-induced hypoglycemia"/>
</condition>
<descriptionSummary
value="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."/>
<description
value="This ResearchStudy Resource was derived from data in the ClinicalTrials.gov record then modified for use to support an M11 Report."/>
<site>
<reference value="#NCT03421379-Location-0"/>
<type value="Location"/>
</site>
<site>
<reference value="#NCT03421379-Location-1"/>
<type value="Location"/>
</site>
<site>
<reference value="#NCT03421379-Location-2"/>
<type value="Location"/>
</site>
<site>
<reference value="#NCT03421379-Location-3"/>
<type value="Location"/>
</site>
<classifier>
<text value="IPDSharing: Yes"/>
</classifier>
<classifier>
<text
value="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."/>
</classifier>
<classifier>
<text value="IPDSharingInfoType: Study Protocol"/>
</classifier>
<classifier>
<text value="IPDSharingInfoType: Statistical Analysis Plan (SAP)"/>
</classifier>
<classifier>
<text value="IPDSharingInfoType: Clinical Study Report (CSR)"/>
</classifier>
<classifier>
<text
value="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."/>
</classifier>
<classifier>
<text
value="IPDSharingAccessCriteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement."/>
</classifier>
<classifier>
<text value="Has Results: True"/>
</classifier>
<classifier>
<text value="Oversight Classifier: oversightHasDmc False"/>
</classifier>
<classifier>
<text value="Oversight Classifier: isFdaRegulatedDrug True"/>
</classifier>
<classifier>
<text value="Oversight Classifier: isFdaRegulatedDevice False"/>
</classifier>
<classifier>
<text value="Oversight Classifier: isUsExport True"/>
</classifier>
<classifier>
<text value="AgreementPISponsorEmployee: False"/>
</classifier>
<classifier>
<text value="AgreementRestrictionType: GT60"/>
</classifier>
<classifier>
<text value="AgreementRestrictiveAgreement: True"/>
</classifier>
<associatedParty>
<name value="Eli Lilly and Company"/>
<role>
<coding>
<system value="http://hl7.org/fhir/research-study-party-role"/>
<code value="sponsor"/>
<display value="Sponsor"/>
</coding>
</role>
</associatedParty>
<associatedParty>
<name value="Eli Lilly and Company, Eli Lilly Japan K.K"/>
<role>
<coding>
<system value="http://hl7.org/fhir/research-study-party-role"/>
<code value="lead-sponsor"/>
<display value="lead-sponsor"/>
</coding>
</role>
</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-director"/>
<display value="study-director"/>
</coding>
</role>
<party>
<display value="Eli Lilly and Company"/>
</party>
</associatedParty>
<associatedParty>
<name value="Medical Expert details on file at Eli Lilly and Company"/>
<role>
<coding>
<system value="http://hl7.org/fhir/research-study-party-role"/>
<code value="general-contact"/>
<display value="general-contact"/>
</coding>
<text value="Medical Expert"/>
</role>
</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>
<progressStatus>
<state>
<coding>
<system value="http://hl7.org/fhir/research-study-status"/>
<code value="approved"/>
<display value="Approved"/>
</coding>
<text value="Sponsor Approval"/>
</state>
<actual value="true"/>
<period>
<start value="2017-10-26"/>
</period>
</progressStatus>
<progressStatus>
<state>
<text value="Version Date"/>
</state>
<actual value="true"/>
<period>
<start value="2017-12-05"/>
</period>
</progressStatus>
<recruitment>
<extension
url="http://example.org/fhir/extension/population-description">
<valueString
value="Seventy-five patients may be enrolled in order to have at least 66 patients (at least 30 patients with T1DM and T2DM, respectively) complete the study. For purposes of this study, a completer is defined as a patient who completes both periods with evaluable primary outcome. If patients discontinue from the study before completion of both periods with evaluable primary outcome for any reason, the patient may be replaced to ensure 66 patients complete the study. The replacement patients will be assigned the same treatment sequence as the patients to be replaced and will complete that treatment sequence in its entirety. Replacement should not occur beyond 75 patients enrolled, if it is expected to have at least 66 patients complete the study. Eligibility of patients for the study will be based on the results of screening medical history, physical examination, vital signs, clinical laboratory tests, and ECG. The nature of any conditions present at the time of the physical examination and any preexisting conditions will be documented. Screening may occur up to 28 days prior to enrollment. Patients who are not enrolled within 28 days of screening may be subjected to an additional medical assessment and/or clinical measurements to confirm their eligibility. Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as protocol waivers or exemptions, are not permitted."/>
</extension>
<extension
url="http://example.org/fhir/extension/recruitment-contraception">
<extension url="details">
<valueString
value="Male patients must use an effective method of contraception for the duration of the study and for 28 days following the last study treatment. Female patients of childbearing potential must use one highly effective method of contraception (<1% failure rate; such as combined oral contraceptive pill, implanted contraceptives, or intrauterine device) or a combination of 2 effective methods of contraception (such as male or female condoms with spermicide [not approved in Japan], diaphragms with spermicide [not approved in Japan], or cervical sponges) during the study and for 28 days following the last study treatment. The patient may choose to use a double barrier method of contraception. Barrier protection methods without concomitant use of a spermicide are not a reliable or acceptable method. Thus, each barrier method must include use of a spermicide. It should be noted that the use of male and female condoms as a double barrier method is not considered acceptable due to the high failure rate when these methods are combined."/>
</extension>
<extension url="definitions">
<valueString value="Not defined in protocol."/>
</extension>
</extension>
<extension
url="http://example.org/fhir/extension/recruitment-restrictions">
<extension url="lifestyle-summary">
<valueString
value="Throughout the study, patients may undergo medical assessments and review of compliance with requirements before continuing in the study."/>
</extension>
<extension url="dietary">
<valueString
value="In both treatment periods, patients will fast for at least 8 hours prior to beginning the hypoglycemia induction procedure. Patients should not be given any calorie-containing food/drink during insulin-induced hypoglycemia and within 90 minutes of glucagon administration unless there is a safety concern. The patients will receive a carbohydrate-rich meal after completion of all pharmacokinetic (PK) blood sample collections, at 240 minutes post glucagon dose. Patients will be given access to calorie-free water up to 240 minutes post study treatment. While resident in the CRU, patients should not consume any food or caloric drinks other than that provided by the CRU. When not resident in the CRU, patients will be encouraged to follow their normal diets"/>
</extension>
<extension url="substances">
<valueString
value="Patients should refrain from caffeine-containing food/beverages (eg, cola, chocolate drinks, tea, and coffee) from Day -1 to discharge from CRU in each period. Patient alcohol intake should not exceed 21 units per week (males up to age 65) and 14 units per week (males over 65 and females) during the study. Patients must not consume alcohol from Day -2 to discharge from CRU in each period. Smoking will not be permitted when resident in the CRU."/>
</extension>
<extension url="activity">
<valueString
value="Patients are encouraged to maintain their regular exercise habits for the duration of the study. However, patients should avoid strenuous exercise 48 hours prior to admission or study visit. From the beginning of hypoglycemia induction to 240 minutes post study treatment, patients should remain recumbent or sitting on the bed."/>
</extension>
<extension url="other">
<valueString value="[Optional section not used here.]"/>
</extension>
</extension>
<extension url="http://example.org/fhir/extension/screen-failure">
<valueString
value="Individuals who do not meet the criteria for participation in this study (screen failure) may not be re-screened."/>
</extension>
<targetNumber value="20"/>
<actualNumber value="75"/>
<eligibility>🔗
<reference value="Group/267506"/>
<type value="Group"/>
<display value="M11 IGBJ Protocol Example Eligibility Criteria"/>
</eligibility>
</recruitment>
<comparisonGroup>
<linkId value="nasal"/>
<name value="Glucagon Nasal Powder"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-arm-type"/>
<code value="experimental"/>
<display value="Experimental"/>
</coding>
</type>
<description
value="A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally."/>
<intendedExposure>
<reference value="#NCT03421379-drug------glucagon-nasal-powder"/>
<type value="EvidenceVariable"/>
<display value="Drug: Glucagon Nasal Powder"/>
</intendedExposure>
</comparisonGroup>
<comparisonGroup>
<linkId value="solution"/>
<name value="Glucagon Hydrochloride Solution"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-arm-type"/>
<code value="active-comparator"/>
<display value="Active Comparator"/>
</coding>
</type>
<description
value="A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)"/>
<intendedExposure>
<reference
value="#NCT03421379-drug------glucagon-hydrochloride-solution"/>
<type value="EvidenceVariable"/>
<display value="Drug: Glucagon Hydrochloride Solution"/>
</intendedExposure>
</comparisonGroup>
<objective>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="label">
<valueString value="Proportion achieving treatment success"/>
</extension>
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="primary"/>
<display value="Primary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>
<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>
<display
value="The proportion of patients achieving treatment success defined as either an increase in PG to >70 mg/dL or an increase of >20 mg/dL from nadir within 30 minutes after administration of glucagon. The nadir is defined as the minimum PG value at the time of or within 10 minutes following glucagon administration."/>
</valueReference>
</extension>
<extension url="population">
<valueReference>🔗
<reference value="Group/267506"/>
<type value="Group"/>
<display value="M11 IGBJ Protocol Example Eligibility Criteria"/>
</valueReference>
</extension>
<extension url="interventionGroup">
<valueId value="nasal"/>
</extension>
<extension url="comparatorGroup">
<valueId value="solution"/>
</extension>
</extension>
<name value="Treatment success"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="primary"/>
<display value="Primary"/>
</coding>
</type>
<description
value="To demonstrate that 3 mg LY900018 is non-inferior to 1 mg IMG for the proportion of patients achieving treatment success from insulin-induced hypoglycemia using a non-inferiority margin of 10%"/>
</objective>
<objective>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="endpoint">
<valueReference>
<display value="serious adverse events (SAEs)"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="label">
<valueString value="treatment-emergent adverse events (TEAEs)"/>
</extension>
<extension url="endpoint">
<valueReference>
<display
value="treatment-emergent adverse events (TEAEs) (including gastrointestinal, nasal, and non-nasal AEs)"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="endpoint">
<valueReference>
<display value="vital signs"/>
</valueReference>
</extension>
</extension>
<name value="Safety and tolerability"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description
value="To compare the safety and tolerability of 3 mg LY900018 with 1 mg IMG"/>
</objective>
<objective>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>
<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>
<display
value="Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>
<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>
<display
value="PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>
<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>
<display
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"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>
<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>
<display
value="PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="type">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="endpoint">
<valueReference>
<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>
<display
value="PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM"/>
</valueReference>
</extension>
</extension>
<name
value="To characterize the PK profile of 3 mg LY900018 compared to 1 mg IMG"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="secondary"/>
<display value="Secondary"/>
</coding>
</type>
<description
value="PK parameters include AUC, Cmax, Tmax PD parameters include BGmax and Tmax"/>
</objective>
<objective>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand">
<extension url="endpoint">
<valueReference>
<display value="Presence of anti-glucagon antibodies"/>
</valueReference>
</extension>
</extension>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="exploratory"/>
<display value="Exploratory"/>
</coding>
</type>
<description
value="Explore the formation of anti-glucagon antibodies to glucagon"/>
</objective>
<objective>
<name
value="To evaluate the recovery from clinical symptoms of hypoglycemia"/>
<type>
<coding>
<system value="http://hl7.org/fhir/research-study-objective-type"/>
<code value="exploratory"/>
<display value="Exploratory"/>
</coding>
</type>
<description value="Hypoglycemia symptoms questionnaire"/>
</objective>
<result>
<type value="EvidenceReport"/>
<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#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-12-19
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change