<custodian> <reference value="Organization/118079"/> <type value="Organization"/> <display value="Computable Publishing LLC"/> </custodian> <relatesTo> <type value="derived-from"/> <targetReference> <reference value="ResearchStudy/267245"/> <type value="ResearchStudy"/> <display value="A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example"/> </targetReference> </relatesTo> <relatesTo> <type value="cite-as"/> <targetMarkdown value="M11 Report Section 14 (References) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568071. Revised 2026-05-31. Available at: https://fevir.net/resources/Composition/568071. Computable resource at: https://fevir.net/resources/Composition/568071#json."/> </relatesTo> <section> <title value="Appendix: References"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218671"/> <display value="ICH M11 Protocol Section 14 APPENDIX: REFERENCES"/> </coding> <text value="section14-references"/> </code> <text> <status value="additional"/><div xmlns="http://www.w3.org/1999/xhtml">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. American Diabetes Association. Glycemic targets. Diabetes Care. 2017;40(suppl 1):S48-S56. 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. 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. 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. 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. 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. 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. 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. 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. 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</div> </text> </section> </Composition>

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version: 2; Last updated: 2026-05-31 00:22:59+0000

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identifier: FEvIR Object Identifier/568071

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category: section14-references

date: 2026-05-31 00:22:59+0000

author: Brian S. Alper, MD, MSPH

title: M11 Report Section 14 (References) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

custodian: Computable Publishing LLC

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target: A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

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M11 Report Section 14 (References) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568071. Revised 2026-05-31. Available at: https://fevir.net/resources/Composition/568071. Computable resource at: https://fevir.net/resources/Composition/568071#json.