M11 Report Section 3 (Trial Objectives and Associated Estimands) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example - TTL Representation - Evidence Based Medicine on FHIR Implementation Guide v1.0.0-ballot3

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 1.0.0-ballot3 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
: 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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fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><div><strong>Prmary Objectives and Associated Estimands</strong>\n    <p><strong>Name: </strong>Treatment success</p>\n    <p><strong>Description </strong>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%</p>\n    <p><strong>Outcome Measures:</strong></p>\n    <p><strong>Proportion achieving treatment success</strong></p>\n    <table>\n        <tbody>\n            <tr>\n                <td><strong>Type</strong></td>\n                <td>primary</td>\n            </tr>\n            <tr>\n                <td><strong>Description</strong></td>\n                <td>The proportion of patients achieving treatment success defined as either an increase in PG to &gt;70 mg/dL or an increase of &gt;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.</td>\n            </tr>\n            <tr>\n                <td><strong>Population</strong></td>\n                <td>M11 IGBJ Protocol Example Eligibility Criteria</td>\n            </tr>\n            <tr>\n                <td><strong>Intervention group</strong></td>\n                <td>M11 IGBJ Protocol Example Eligibility Criteria</td>\n            </tr>\n            <tr>\n                <td><strong>Control group</strong></td>\n                <td>M11 IGBJ Protocol Example Eligibility Criteria</td>\n            </tr>\n            <tr>\n                <td><strong>Endpoint</strong></td>\n                <td>Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia (NCT03421379)</td>\n            </tr>\n        </tbody>\n    </table><p>   </p>\n</div>\n<div><strong>Secondary Objectives and Associated Estimands</strong>\n    <p><strong>Name: </strong>Safety and tolerability</p>\n    <p><strong>Description </strong>To compare the safety and tolerability of 3 mg LY900018 with 1 mg IMG</p>\n    <p><strong>Outcome Measures:</strong></p>\n    <p><strong>Unnamed outcome measure</strong></p>\n    <table>\n        <tbody>\n            <tr>\n                <td><strong>Endpoint</strong></td>\n                <td>serious adverse events (SAEs)</td>\n            </tr>\n        </tbody>\n    </table><p>   </p>\n    <p><strong>Unnamed outcome measure</strong></p>\n    <table>\n        <tbody>\n            <tr>\n                <td><strong>Description</strong></td>\n                <td>treatment-emergent adverse events (TEAEs) (including gastrointestinal, nasal, and non-nasal AEs)</td>\n            </tr>\n            <tr>\n                <td><strong>Endpoint</strong></td>\n                <td>treatment-emergent adverse events (TEAEs)</td>\n            </tr>\n        </tbody>\n    </table><p>   </p>\n    <p><strong>Unnamed outcome measure</strong></p>\n    <table>\n        <tbody>\n            <tr>\n                <td><strong>Endpoint</strong></td>\n                <td>vital signs</td>\n            </tr>\n        </tbody>\n    </table><p>   </p>\n    <p><strong>Name: </strong>To characterize the PK profile of 3 mg LY900018 compared to 1 mg IMG</p>\n    <p><strong>Description </strong>PK parameters include AUC, Cmax, Tmax PD parameters include BGmax and Tmax</p>\n    <p><strong>Outcome Measures:</strong></p>\n    <p><strong>Unnamed outcome measure</strong></p>\n    <table>\n        <tbody>\n            <tr>\n                <td><strong>Type</strong></td>\n                <td>secondary</td>\n            </tr>\n            <tr>\n                <td><strong>Endpoint</strong></td>\n                <td>Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) (NCT03421379)</td>\n            </tr>\n        </tbody>\n    </table><p>   </p>\n    <p><strong>Unnamed outcome measure</strong></p>\n    <table>\n        <tbody>\n            <tr>\n                <td><strong>Type</strong></td>\n                <td>secondary</td>\n            </tr>\n            <tr>\n                <td><strong>Endpoint</strong></td>\n                <td>PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)</td>\n            </tr>\n        </tbody>\n    </table><p>   </p>\n    <p><strong>Unnamed outcome measure</strong></p>\n    <table>\n        <tbody>\n            <tr>\n                <td><strong>Type</strong></td>\n                <td>secondary</td>\n            </tr>\n            <tr>\n                <td><strong>Endpoint</strong></td>\n                <td>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 (NCT03421379)</td>\n            </tr>\n        </tbody>\n    </table><p>   </p>\n    <p><strong>Unnamed outcome measure</strong></p>\n    <table>\n        <tbody>\n            <tr>\n                <td><strong>Type</strong></td>\n                <td>secondary</td>\n            </tr>\n            <tr>\n                <td><strong>Endpoint</strong></td>\n                <td>PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)</td>\n            </tr>\n        </tbody>\n    </table><p>   </p>\n    <p><strong>Unnamed outcome measure</strong></p>\n    <table>\n        <tbody>\n            <tr>\n                <td><strong>Type</strong></td>\n                <td>secondary</td>\n            </tr>\n            <tr>\n                <td><strong>Endpoint</strong></td>\n                <td>PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)</td>\n            </tr>\n        </tbody>\n    </table><p>   </p>\n</div>\n<div><strong>Exploratory Objectives</strong>\n    <p><strong>Description </strong>Explore the formation of anti-glucagon antibodies to glucagon</p>\n    <p><strong>Outcome Measures:</strong></p>\n    <p><strong>Unnamed outcome measure</strong></p>\n    <table>\n        <tbody>\n            <tr>\n                <td><strong>Endpoint</strong></td>\n                <td>Presence of anti-glucagon antibodies</td>\n            </tr>\n        </tbody>\n    </table><p>   </p>\n    <p><strong>Name: </strong>To evaluate the recovery from clinical symptoms of hypoglycemia</p>\n    <p><strong>Description </strong>Hypoglycemia symptoms questionnaire</p>\n</div></div>"^^rdf:XMLLiteral ]     ] ;
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Diagnosis of T2DM based on the World Health Organization (WHO) diagnostic criteria\n..ii.	have received the following daily insulin therapy with or without oral anti-hyperglycemic medications (OAMs) for at least 1 year \n...1)	insulin: long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) alone, or in combination with rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine) or CSII \n...2)	OAM: up to 3 of the following OAMs in accordance with local regulations: metformin, dipeptidyl peptidase-4 inhibitor, sodium glucose cotransporter 2 inhibitor, sulfonylurea (should not be more than half of maximum approved doses), glinides, alpha-glucosidase inhibitor, or thiazolidine \n..iii.	are between 20 and 70 years old at the time of informed consent \n..iv.	have a body mass index of 18.5 to 35.0 kg/m2 at the time of screening \n2.	have a hemoglobin A1c value ≤10% at the time of screening \n3.	agree to use an effective method of contraception, defined by study protocol\n4.	have clinical laboratory test results within normal reference range (except for glycemic parameters) for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator \n5.	have venous access sufficient to allow for blood sampling and administration of insulin for IV administration as per the protocol \n6.	are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures \n7.	are able and willing to give signed informed consent.\n\n**Exclusion Criteria** \nPatients will be excluded from study enrollment if they meet any of the following criteria at screening and/or enrollment: \n1.	are investigative site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, biological or legal guardian, child, or sibling \n2.	are Lilly employees \n3.	are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study \n4.	have participated, within the last 4 months, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 4 months or 5 half-lives (whichever is longer) should have passed from the last dose of investigational product \n5.	have previously completed or withdrawn from this study or any other study investigating LY900018, and have previously received LY900018 \n6.	have known allergies or sensitivity to LY900018, glucagon, related compounds, or any components of the formulation, or history of significant atopy \n7.	have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study\n8.	any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator \n9.	have received a total daily dose of insulin &gt;1.2 U/kg at the time of screening \n10.	have poorly controlled hypertension (ie, supine systolic BP &gt;165 mm Hg or supine diastolic BP &gt;95 mm Hg) at screening, or a change in antihypertensive medications within 30 days prior to screening \n11.	have a history of pheochromocytoma (ie, adrenal gland tumor) or insulinoma \n12.	have a history of an episode of severe hypoglycemia (as defined by an episode that required third party assistance for treatment) in the 1 month prior to screening or have a history of loss of consciousness within the last 2 years induced other than by hypoglycemia \n13.	have a history of epilepsy or seizure disorder \n14.	have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM or T2DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data \n15.	have known or ongoing psychiatric disorders that, in the opinion of the investigator, may preclude the patient from following and completing the protocol \n16.	regularly use known drugs of abuse and/or show positive findings on urinary drug screening \n17.	show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies and/or antigen \n18.	show evidence of hepatitis C and/or positive hepatitis C antibody\n19.	 show evidence of hepatitis B and/or positive hepatitis B surface antigen \n20.	show evidence of syphilis and/or are positive for syphilis test \n21.	are women who are lactating \n22.	use of daily systemic beta-blocker, indomethacin, warfarin, anticholinergic drugs \n23.	have donated 400 mL or more blood in the last 12 weeks (males) or in the last 16 weeks (females), or any blood donation (including apheresis) within the last 4 weeks, or total volume of blood donation within 12 months is 1200 mL (males)/800 mL (females) or more at screening\n24.	have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to stop alcohol consumption from Day -2 to discharge from CRU in each period (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits) \n25.	in the opinion of the investigator or sponsor, are unsuitable for inclusion in the study \n26.	have pre-proliferative and proliferative retinopathy or maculopathy requiring treatment or not clinically stable in the last 6 months, or patients with active changes in subjective eye symptoms as determined by the investigator if an eye exam has not been performed in the last 6 months. Note: If an eye examination has been performed no more than 6 months before screening, it will not have to be repeated; however, the investigator will need to confirm via interview that there is no change in subjective symptoms.</td></tr><tr><td>Treatment</td><td>Glucagon Nasal Powder (Experimental)</td></tr><tr><td>Treatment</td><td>Glucagon Hydrochloride Solution (Active Comparator)</td></tr><tr><td>Endpoint</td><td><p>Proportion achieving treatment success</p><p>Endpoint title: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia (NCT03421379)</p><p>Outcome description: The proportion of patients achieving treatment success defined as either an increase in PG to &gt;70 mg/dL or an increase of &gt;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.</p></td></tr><tr><td>Population-level Summary</td><td>risk difference</td></tr></tbody></table></div>"^^rdf:XMLLiteral ]         ] ;
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  ] ) . #