Narrative Elements: Composition IGBJ Protocol Narrative 1.3

Narrative Elements: Composition IGBJ Protocol Narrative 2.1

Narrative Elements: Composition IGBJ Protocol Narrative 5.1

Narrative Elements: Composition IGBJ Protocol Narrative 9

M11_ProtocolAmendment

url

scope

value: C217026

url

Country ValueSet

value: DE

url

Country ValueSet

value: GB

url

region

value: AU-NSW

url

site

value: https://example.org/site-identifier/sss

url

approvalDate

value: 2017-12-05

url

signature

value: No display for Signature (data: 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)

url

signatureURL

value: https://somelocation

url

signatureMethod

value: electronic and wet ink copy

scope: C41065

number: 234

url

ResearchStudyStudyAmendmentScopeImpact

scope: C68846

number: 983

url

ResearchStudyStudyAmendmentScopeImpact

url

primaryReason

value: Regulatory Agency Request To Amend

url

secondaryReason

value: Manufacturing Change

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summary

value: Regulator required manufacturing chanage.

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substantialImpactSafety

value: C49488

url

substantialImpactSafetyComment

value: Specifically implemented to decrease safety risks.

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substantialImpactReliability

value: C17998

url

substantialImpactReliabilityComment

value: ccc

detail: amendment one

rationale: clarification

section: 1.1 Protocol Synopsis

url

ResearchStudyStudyAmendmentDetails

detail: amendment two

rationale: exclude regular drinkers

section: 5.3 Exclusion Criteria

url

ResearchStudyStudyAmendmentDetails

url

rationale

value: Updates to address safety concern & align with product guidelines.

url

description

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: • An exclusion criterion for patients with retinopathy or maculopathy was added due to the potential risk of fundal hemorrhage induced by hypoglycemia. • 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).

ResearchStudySponsorConfidentialityStatement: All data is confidential

identifier: Regulatory Agency Identifier/NCT03421379 (use: official, ), Sponsor Identifier/I8R-JE-IGBJ (use: usual, ), Amendment Identifier/I8R-JE-IGBJ(a) (use: usual, )

version: (a)

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

Labels

date: 2017-12-05

status: Draft

phase: Phase 3

Focus

condition: Iatrogenic hypoglycaemia