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    v: Generated Narrative: Composition 568072 version: 10; Last updated: 2026-06-22 20:23:02+0000 Profile: M11ReportContainer Artifact Description: Example of M11ReportContainer Profile ArtifactPublicationStatus: Active url: https://fevir.net/resources/Composition/568072 identifier: FEvIR Object Identifier/568072 status: Final type: CeSHarP Report date: 2026-06-22 20:23:02+0000 author: Brian S. Alper, MD, MSPH title: M11 Report for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example custodian: Computable Publishing LLC relatesTo type: Derived From target: A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example relatesTo type: Cite As target: M11 Report 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 568072. Revised 2026-06-22. Available at: https://fevir.net/resources/Composition/568072. Computable resource at: https://fevir.net/resources/Composition/568072#json.
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      v: Clinical trial protocol Clinical trial protocol
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    v: A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example
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  v: M11 Report for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example
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    v: M11 Report 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 568072. Revised 2026-06-22. Available at: https://fevir.net/resources/Composition/568072. Computable resource at: https://fevir.net/resources/Composition/568072#json.
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        v: ICH M11 Protocol Section Title Page
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      v: Sponsor Confidentiality Statement: 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. 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: (a) Version Date: 05-Dec-2017 Sponsor’s Investigational Product Code(s): LY900018 Investigational Product Name(s): Glucagon Trial Phase: Phase 3 Short Title: A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example Sponsor Name and Address: Eli Lilly Japan K.K Japan Regulatory or Clinical Trial Identifier(s): ClinicalTrials.gov NCT03421379 identifier 16962 assigned by Eli Lilly and Company Amendment Identifier I8R-JE-IGBJ(a) Sponsor Approval: 26-Oct-2017 Sponsor Signatory: Signature block and date on file at Eli Lilly and Company Medical Expert Contact: Medical Expert details on file at Eli Lilly and Company Amendment Details: This is the first protocol amendment. Overall Rationale for the Amendment: Updates to address safety concern & align with product guidelines. The table below describes the current amendment. Approximate % Enrolled at time of Sponsor Approval: Approximate ??% enrolled Globally. (not known for creating sample protocol) Reason(s) for Amendment: Primary: Safety, Secondary: NA Amendment Summary: 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 maculop…
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    v: 1 Protocol Summary
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        v: ICH M11 Protocol Section 1 PROTOCOL SUMMARY
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      v: 1 PROTOCOL SUMMARY 1.1 Protocol Synopsis 1.1.1 Primary and Secondary Objectives and Estimands Objectives Primary • 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% Endpoints Primary • 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. Objectives Secondary • To compare the safety and tolerability of 3 mg LY900018 with 1 mg IMG • To characterize the PK profile of 3 mg LY900018 compared to 1 mg IMG • To characterize the PD profile of 3 mg LY900018 compared to 1 mg IMG Endpoints Secondary • SAE, TEAEs (including gastrointestinal, nasal, and non-nasal AEs), vital signs • PK parameters include AUC, Cmax, Tmax • PD parameters include BGmax and Tmax Abbreviations: AE = adverse event; AUC = area under the concentration versus time curve; BGmax = maximal plasma glucose concentration; Cmax = maximal concentration; IMG = intramuscular glucagon; PD = pharmacodynamics; PG = plasma glucose; PK = pharmacokinetics; SAE = serious adverse event; TEAE = treatment-emergent adverse event; Tmax = time to maximal concentration. (Estimands were not included in this older sample protocol.) 1.1.2 Overall Design Key aspects of the trial design are summarised below. Intervention Model: 2-treatment, 2-period cross-over Population Type: With Disease Control Type: Active comparator Population Diagnosis or Condition: T1DM, T2DM Control Description: IMG GlucaGen, Novonordisk A/S Population Age: Minimum: 18 years of age Maximum: 70 years of age Intervention Assignment Method: Randomized, open label Site Distribution and Geographic Scope: Japan Number of Arms 4 Trial Blind Schema Open Label Blinded Roles …
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      v: M11 Report Section 1 (Protocol Summary) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example
section:
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    v: 2 Introduction
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        v: ICH M11 Protocol Section 2 INTRODUCTION
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      v: 2 INTRODUCTION 2.1 Purpose of Trial Nasal glucagon (LY900018) is a powder formulation of human glucagon for the rescue treatment of hypoglycemia packaged in a user-friendly, single-use, nasal dosing device that delivers 3 mg glucagon powder for absorption through the nasal mucosa. The glucagon component of LY900018 is a synthetic single-chain, 29-amino-acid polypeptide identical to human glucagon. LY900018 is being developed for the rescue treatment of hypoglycemia. Currently, glucagon in a liquid form lacks physical and chemical stability; thus, marketed products require reconstitution of glucagon powder before the product can be administered through intramuscular (IM) injection. LY900018 combines stable, synthetic glucagon and a nasal dosing device that for effective use obviates reconstitution, injection, and moreover, patient inhalation. Because of these advantages, LY900018 may offer a significant improvement in the treatment of severe hypoglycemia occurring outside of the hospital setting. The aim of this study is to compare LY900018 with IM glucagon (IMG), a currently approved product that requires reconstitution prior to administration through IM injection, in Japanese patients with type 1 diabetes mellitus (T1DM) and patients with type 2 diabetes mellitus (T2DM) who achieve treatment success during controlled insulin-induced hypoglycemia. Treatment success is defined as an increase in plasma glucose (PG) to ≥70 mg/dL or an increase of ≥20 mg/dL from the PG nadir within 30 minutes after receiving glucagon, without the patient receiving additional treatments to increase PG. The nadir is defined as the minimum PG measurement at the time of or within 10 minutes following glucagon administration. The design and conduct of Study IGBJ are similar to the completed Phase 3 Study I8R-MC-IGBC (IGBC) (Rickels et al. 2016) and the planned Phase 1 Study I8R-MC-IGBI. 2.2 Assessment of Risks and Benefits 2.2.1 Risk Summary and Mitigation Strategy 2.2.1 Risk Summary and Mit…
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      v: M11 Report Section 2 (Introduction) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example
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    v: 3 Trial Objectives and Estimands
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        v: ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS

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  v: 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS 3.1 Primary Objective(s) and Associated Estimand(s) 3.1.1 Primary Objective 1 Primary objective label: Treatment success Primary objective description: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% Type Primary Population Study Population. Treatment Glucagon Nasal Powder (Experimental) Treatment Glucagon Hydrochloride Solution (Active Comparator) Endpoint Proportion achieving treatment success Endpoint title: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia (NCT03421379) Outcome description: 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 risk difference 3.2 Secondary Objective(s) and Associated Estimand(s) 3.2.1 Secondary Objective 1 Secondary objective label: Safety and tolerability Secondary objective description: To compare the safety and tolerability of 3 mg LY900018 with 1 mg IMG Estimand Characteristic Description Endpoint serious adverse events (SAEs) 3.2.1 Secondary Objective 2 Secondary objective label: Safety and tolerability Secondary objective description: To compare the safety and tolerability of 3 mg LY900018 with 1 mg IMG Estimand Characteristic Description Endpoint treatment-emergent adverse events (TEAEs) Outcome description: treatment-emergent adverse events (TEAEs) (including gastrointestinal, nasal, and non-nasal AEs) 3.2.1 Secondary Objective 3 Estimand Characteristic Description Endpoint vital signs 3.2.1 Secondary Objective 4 Secondary objective label: To characterize the PK profile of 3 mg LY900018 compared to 1 mg IMG S…

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  v: M11 Report Section 3 (Trial Objectives and Associated Estimands) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

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  v: 4 Trial Design
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      v: ICH M11 Protocol Section 4 TRIAL DESIGN
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    v: 4 TRIAL DESIGN 4.1 Description of Trial Design This is a Phase 3, multicenter, randomized, open-label, active comparator, single-dose, 2-period, 2-treatment, crossover study in Japanese patients with T1DM and T2DM. The study consists of a screening period; treatment period 1 (Period 1); washout period; treatment period 2 (Period 2); follow-up period. Figure IGBJ.1 illustrates the study design. Prior to the study drug administration on Period 1 Day 1, patients will be randomly assigned to a treatment sequence (either LY900018 in Period 1 and IMG in Period 2, or vice versa). Safety data will be reviewed after the first 6 patients (regardless of type of diabetes) are administered LY900018 in Period 2, and the remaining patients will be dosed after confirmation of the safety. The investigator and Lilly clinical research physician (CRP) or scientist will review available safety data, including AEs, SAEs, vital signs, electrocardiograms (ECGs), and safety laboratory tests, from these patients after they complete Period 2 Day 1. If no clinically significant safety findings for treatment or study procedure are noted, the remaining patients will be dosed. In each treatment period, patients will undergo a procedure to induce hypoglycemia using IV insulin infusion and serial blood sampling will be conducted to monitor bedside PG for safety. The insulin infusion will be stopped once the PG level reaches <60 mg/dL and approximately 5 minutes later patients will be administered either 3 mg LY900018 or 1 mg IMG (GlucaGen). Serial blood sampling will be performed for glucagon (for pharmacokinetics [PK]) and PG (for pharmacodynamics [PD]) concentration measurements immediately before and up to 4 hours following the administration of glucagon. In each period, patients will remain in the CRU for at least 6 hours after glucagon administration. All patients will receive a carbohydrate-rich meal prior to discharge. Patients may stay longer as needed, at the discretion of the investigator…
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    v: M11 Report Section 4 (Trial Design) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

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  v: 5 Trial Population
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      v: ICH M11 Protocol Section 5 TRIAL POPULATION
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    v: 5 TRIAL POPULATION 5.1 Description of Trial Population and Rationale 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. 5.2 Inclusion Criteria Patients are eligible for inclusion in the study only if they meet all of the following criteria at screening and/or enrollment: 1. Meet either T1DM-specific eligibility criteria or T2DM-specific eligibility criteria .a. T1DM-specific criteria ..i. Diagnosis of T1DM based on the World Health Organization (WHO) diagnostic criteria ..ii. have been on the following daily insulin therapy for at least 1 year ...1) multiple daily injection of long-acting insulin analog (either insulin glar…
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    v: M11 Report Section 5 (Trial Population) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

title:
  v: 6 Trial Intervention
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      v: ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY
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    v: 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY This study involves a comparison of 3 mg of LY900018 administered once nasally to 1 mg glucagon administered IM (comparator). Table IGBJ.2 shows the study treatment information. Table IGBJ.2 Study Treatments Treatment Name LLY900018 GlucaGen Dosage Formulation Dry powder Dry powder Dosage Levels 3 mg glucagon 1 mg glucagon Route of Administration Intranasal Intramuscular Dosing Instructions Administer a single nasal dose Administer a single intramuscular upon hypoglycemia onset injection upon hypoglycemia onset. 6.1 Description of Investigational Trial Intervention This study involves a comparison of 3 mg of LY900018 administered once nasally to 1 mg glucagon administered IM (comparator). 6.2 Rationale for Investigational Trial Intervention Dose and Regimen Results from studies in both pediatric and adult populations confirm that, while the physiological response to glucagon does appear to saturate between the 2- and 3-mg LY900018 doses, the lower 2-mg dose may not always elicit the maximum response needed in an emergency situation of severe hypoglycemia. The 3-mg dose provides more consistent clinical efficacy compared to the 2-mg dose and is similarly well tolerated in both pediatric and adult patients. The 1-mg dose of IMG is selected as the approved dose for the rescue treatment of hypoglycemia in Japan. Based on LY900018 exposure, efficacy, and safety, the 3-mg dose was selected for the Phase 3 studies. Therefore, in the current study, the 3-mg LY900018 dose will be used to compare against 1 mg IMG. 6.3 Investigational Trial Intervention Administration The procedure for insulin-induced hypoglycemia will require an IV infusion of diluted human regular insulin (0.3 U/mL by diluting 15 U human regular insulin [100 U/mL] into 50 mL saline). Details regarding hypoglycemia induction and glucagon administration procedures are included in Sections 9.2.1 and 9.2.2, respectively. The investigator or designee is responsible for…
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    v: M11 Report Section 6 (Trial Intervention) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

title:
  v: 7 Participant Discontinuation
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      v: ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL
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    v: 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL 7.1 Discontinuation of Trial Intervention for Individual Participants 7.1.1 Permanent Discontinuation of Trial Intervention See Section 7.2 7.1.2 Temporary Discontinuation of Trial Intervention Not Applicable. 7.1.3 Rechallenge Not Applicable. 7.2 Participant Discontinuation or Withdrawal from the Trial Patients will be discontinued in the following circumstances: • enrollment in any other clinical study involving an investigational product or enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study • participation in the study needs to be stopped for medical, safety, regulatory, or other reasons consistent with applicable laws, regulations, and good clinical practice • investigator decision o the investigator decides that the patient should be discontinued from the study for any reason. If this decision is made because of an AE, SAE, or a severe hypoglycemia event, appropriate measures are to be taken. Lilly or its designee is to be alerted. • patient decision o the patient, or legal representative, requests to be withdrawn from the study Patients discontinuing from the study prematurely for any reason must complete AE and follow-up procedures as shown in the Schedule of Activities (Section 1.3) 7.2.1 Discontinuation of the Study Following the review of the safety data from the first 6 patients to complete Period 2 Day 1, the study will be stopped if deemed necessary for patient safety in the opinion of the Investigator and sponsor (Section 10.3.7). The study will be discontinued if Lilly or its designee judges it necessary for medical, safety, regulatory, or other reasons consistent with applicable laws, regulations, and GCP 7.3 Management of Loss to Follow-Up A patient will be considered lost to follow-up if he or she repeatedly fails to return for scheduled visits and is unable to be contacted by the stu…
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    v: M11 Report Section 7 (Participant Discontinuation) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

title:
  v: 8 Trial Assessments
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      v: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
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    v: 8 TRIAL ASSESSMENTS AND PROCEDURES 8.1 Trial Assessments and Procedures Considerations Section 2 lists the Schedule of Activities, detailing the study procedures and their timing. Appendix 2 lists the laboratory tests that will be performed for this study. Appendix 5 provides a summary of the maximum number and volume of invasive samples, for all sampling, during the study. Unless otherwise stated in subsections below, all samples collected for specified laboratory tests will be destroyed within 60 days of receipt of confirmed test results. Certain samples may be retained for a longer period, if necessary, to comply with applicable laws, regulations, or laboratory certification standards 8.2 Screening/Baseline Assessments and Procedures See Schedule of Activities Section 1.3 & Clinical Lab Tests. 8.3 Efficacy Assessments and Procedures Plasma glucose levels will be measured as described in Section 9.2.3 and will be used to assess efficacy outcomes. 8.3.1 Primary Efficacy Assessments The primary efficacy measure is 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. 8.3.2 Secondary Efficacy Assessments Secondary efficacy measures will be determined from the pharmacodynamic (PD) characterization of PG profiles, including evaluation of change from baseline PG concentrations. 8.3.3 Exploratory Efficacy Assessments Subjective hypoglycemia symptoms will be assessed using a self-reported assessment tool (Edinburgh Hypoglycemia Scale; Appendix 7) during the initiation of the hypoglycemia induction, as well as at various time points following the administration of either LY900018 or IMG (see Schedule of Activities; Section 2). The ability of the patient to identify hypoglycemic symptoms and describe their frequency will be captured at Period 1 Day -1 (see Schedule of Activities; Section 2). This self-report assessment will be done us…
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    v: M11 Report Section 8 (Trial Assessments) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

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  v: 9 Adverse Events
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      v: ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS
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    v: 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS 9.1 Definitions 9.1.1 Definitions of Adverse Events Investigators are responsible for monitoring the safety of patients who have entered this study and for alerting Lilly or its designee to any event that seems unusual, even if this event may be considered an unanticipated benefit to the patient. The investigator is responsible for the appropriate medical care of patients during the study. Investigators must document their review of each laboratory safety report. The investigator remains responsible for following, through an appropriate health care option, AEs that are serious or otherwise medically important, considered related to the investigational product or the study, or that caused the patient to discontinue the investigational product before completing the study. The patient should be followed until the event resolves, stabilizes with appropriate diagnostic evaluation, or is reasonably explained. The frequency of follow-up evaluations of the AE is left to the discretion of the investigator. After the informed consent form is signed, study site personnel will record, via CRF, the occurrence and nature of each patient’s preexisting conditions, including clinically significant signs and symptoms of the disease under treatment in the study. Additionally, site personnel will record any change in the condition(s) and the occurrence and nature of any AEs. The investigator will interpret and document whether or not an AE has a reasonable possibility of being related to study treatment, medical device, or a study procedure, taking into account the disease, concomitant treatment, or pathologies. A “reasonable possibility” means that there is a potential cause and effect relationship between the investigational product, medical device, and/or study procedure and the AE. Planned surgeries should not be reported as AEs unless the underlying med…
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    v: M11 Report Section 9 (Adverse Events) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

title:
  v: 10 Statistical Considerations
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      v: ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS
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    v: 10 STATISTICAL CONSIDERATIONS 10.1 General Considerations A detailed description of patient disposition will be provided at the end of the study. A total of 66 completers are required in the study in order to achieve the primary objective with at least 90% power using the following assumptions: • A treatment success rate of 98% for both treatments • A non-inferiority margin (NIM) of 10% • One-sided alpha level of 0.025 • A within-patient correlation of zero between 2 treatment visits The primary analysis will be a treatment comparison of the percentage of patients, including both T1DM and T2DM, who achieve treatment success. The percentage of patients who achieve treatment success within each treatment group and the difference in the percentages between the 2 treatment groups will be computed. A 2-sided 95% confidence interval (CI) will be obtained from the 1-sample mean of the paired differences in primary outcome (1=outcome observed; 0=outcome not observed) across 2 treatment visits. Non-inferiority of LY900018 will be declared if the upper limit of the 2-sided 95% CI constructed on the difference in percentage (IMG - LY900018) is less than the NIM of 10% 10.2 Analysis Sets Proportion of patients discontinued from the study and the reasons for discontinuation will be summarized by treatment group for all randomized patients. 10.3 Analyses of Demographics and Other Baseline Variables The patients’ baseline characteristics and demographic characteristics will be recorded, listed, and will be summarized for all randomized patients 10.4 Analyses Associated with the Primary Objective(s) 10.4.1 Primary Objective 1 10.4.1.1 Statistical Analysis Method Statistical analysis of this study will be the responsibility of Eli Lilly and Company or its designee. Efficacy, PK, and PD analyses will be conducted on the full analysis set. This set includes all data from all randomized patients receiving at least one dose of the investigational product according to the treatment alloc…
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    v: M11 Report Section 10 (Statistical Considerations) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

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  v: 11 Trial Oversight
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      v: ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS
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    v: 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS 11.1 Regulatory and Ethical Considerations This study will be conducted in accordance with the protocol and with: 1) consensus ethics principles derived from international ethics guidelines, including the Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines 2) applicable ICH GCP Guidelines 3) applicable laws and regulations Some of the obligations of the sponsor will be assigned to a third party organization. 11.2 Trial Oversight 11.2.1 Investigator Responsibilities Ethical Review The investigator must give assurance that the ethical review board (ERB) was properly constituted and convened as required by International Council for Harmonization (ICH) guidelines and other applicable laws and regulations. Documentation of ERB approval of the protocol and the ICF must be provided to Lilly before the study may begin at the investigative site(s). Lilly or its representatives must approve the ICF before it is used at the investigative site(s). All ICFs must be compliant with the ICH guideline on good clinical practice (GCP). The study site’s ERB(s) should be provided with the following: • the current Investigator’s Brochure or Package Insert and updates during the course of the study • ICF • relevant curricula vitae Protocol Signatures After reading the protocol, each principal investigator will sign the protocol signature page and send a copy of the signed page to a Lilly representative Final Report Signature The final report coordinating investigator or designee will sign the clinical study report for this study, indicating agreement that, to the best of his or her knowledge, the report accurately describes the conduct and results of the study. The investigator with the most enrolled patients will serve as the final report coordinating investigator. If this investigator is unable to fulfill this function, another investigator will be chosen by L…
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    v: M11 Report Section 11 (Trial Oversight) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

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  v: 12 Supporting Details
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      v: ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS
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    v: 12 APPENDIX: SUPPORTING DETAILS 12.1 Clinical Laboratory Tests 7 pages of images replaced with this statement. 12.2 Country/Region-Specific Differences Not applicable. 12.3 Prior Protocol Amendment(s) Not applicable. This is the first protocol amendment.
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    v: M11 Report Section 12 (Supporting Details) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

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  v: 13 Glossary
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      v: ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS
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    v: 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS 3 pages of images replaced with this statement
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    v: M11 Report Section 13 (Glossary) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

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  v: 14 References
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      v: ICH M11 Protocol Section 14 APPENDIX: REFERENCES
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    v: 14 APPENDIX: REFERENCES 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…
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    v: M11 Report Section 14 (References) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example