INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USEICH HARMONISED GUIDELINE
CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL
(CESHARP)
| Full 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 |
| Sponsor Protocol Identifier: | I8R-JE-IGBJ |
| Original Protocol: | No |
| Version Number: | 1 |
| Version Date: | (expected ResearchStudy.date) |
| Amendment Identifier: | I8R-JE-IGBJ(a) |
| Amendment Scope: | (expected ResearchStudy.extension[url=http://example.org/fhir/extension/studyAmendment or http://example.org/fhir/extension/studyAmendment]/valueCode) |
| Compound Code(s): | (expected Substance in ResearchStudy.focus.reference.reference) |
| Trial Phase: | Phase III Trial |
| Short Title: | (expected ReseachStudy.label[type/coding[system/value='http://hl7.org/fhir/title-type'].code) |
| Sponsor Name and Address: | (expected Organization with id cb1d78b1-50af-4346-8905-716b4d113cb9) |
| Manufacturer Name and Address: | (expected SubstanceDefinition.manufacturer via ResearchStudy.focus.reference.reference) |
| Regulatory Agency Identifier Number(s): | (expected ResearchStudy.identifier with system https://example.org/regulatory-agency-identifier) |
| Sponsor Approval Date: | (expected ResearchStudy.progressStatus with code sponsor-approved (system http://example.org/fhir/research-study-classifiers-extended) |
Sponsor Signatory:
(expected ResearchStudy.associatedParty with role sponsor-signatory (system http://hl7.org/fhir/research-study-party-role)
Medical Expert Contact: (expected ResearchStudy.associatedParty with role medical-expert (system http://hl7.org/fhir/research-study-party-role)
SAE Reporting Method: (expected string extension with url http://example.org/fhir/extension/saeReportingMethod)
Amendment Details: (expected string extension with url http://example.org/fhir/extension/studyAmendment or http://hl7.org/fhir/uv/ebm/StructureDefinition/studyAmendment)
Overall Rationale for the Amendment: (expected string extension with url http://example.org/fhir/extension/studyAmendment or http://hl7.org/fhir/uv/ebm/StructureDefinition/studyAmendment and sub-extension string url rationale)
Medical Expert Contact: (expected ResearchStudy.associatedParty with role medical-expert (system http://hl7.org/fhir/research-study-party-role)
SAE Reporting Method: (expected string extension with url http://example.org/fhir/extension/saeReportingMethod)
Amendment Details: (expected string extension with url http://example.org/fhir/extension/studyAmendment or http://hl7.org/fhir/uv/ebm/StructureDefinition/studyAmendment)
Overall Rationale for the Amendment: (expected string extension with url http://example.org/fhir/extension/studyAmendment or http://hl7.org/fhir/uv/ebm/StructureDefinition/studyAmendment and sub-extension string url rationale)
3 TRIAL OBJECTIVES AND ESTIMANDS
3.1 Primary Objective(s) and Associated Estimand(s)
3.1.1 Primary Estimand(s)
3.2 Secondary Objective(s) and Associated Estimand(s)
(expecting ResearchStudy.objective of type 'secondary')
3.3 Exploratory Objective(s)
(expecting ResearchStudy.objective of type 'exploratory')
3.1 Primary Objective(s) and Associated Estimand(s)
3.1.1 Primary Estimand(s)
| Estimand Characteristic | Description |
|---|---|
| Endpoint | 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. |
| Population-Level Summary | |
| Intercurrent Event | Strategy |
3.2 Secondary Objective(s) and Associated Estimand(s)
(expecting ResearchStudy.objective of type 'secondary')
3.3 Exploratory Objective(s)
| Objective | Endpoint |
|---|
(expecting inclusion and exlusion in ResearchStudy.recruitment)