M11 Report Section 1 (Protocol Summary) 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 1 (Protocol Summary) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

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@prefix fhir: <http://hl7.org/fhir/> .
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@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

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fhir:title [ fhir:v "Protocol Summary" ] ;
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fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Objectives Primary </p><p>• 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><p>Endpoints Primary </p><p>• 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><p>Objectives Secondary </p><p>• To compare the safety and tolerability of 3 mg LY900018 with 1 mg IMG </p><p>• To characterize the PK profile of 3 mg LY900018 compared to 1 mg IMG</p><p> • To characterize the PD profile of 3 mg LY900018 compared to 1 mg IMG </p><p>Endpoints Secondary</p><p> • SAE, TEAEs (including gastrointestinal, nasal, and non-nasal AEs), vital signs</p><p> • PK parameters include AUC, Cmax, Tmax</p><p> • PD parameters include BGmax and Tmax </p><p>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. </p><p>(Estimands were not included in this older sample protocol.)</p></div>"^^rdf:XMLLiteral ]         ]       ] [
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fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>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</p></div>"^^rdf:XMLLiteral ]         ]       ] [
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fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Seventy-five patients may be enrolled in order to have at least 66 patients (at least 30 patients with T1DM and T2DM, respectively) complete 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. Replacement should not occur beyond 75 patients enrolled, if it is expected to have at least 66 patients complete the study.</p></div>"^^rdf:XMLLiteral ]         ]       ] [
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fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Total planned duration of trial intervention for each participant: 2 days Total planned duration of trial participation for each participant: 6 weeks Patients will undergo a screening examination within 28 days prior to enrollment. Patients will be administered a single dose in Periods 1 and 2, which will be separated by a washout period of 3 to 14 days. Patients will return for a follow-up visit 26 to 30 days after the last study treatment. Patients will undergo a screening examination within 28 days prior to enrollment. Patients will be administered a single dose in Periods 1 and 2, which will be separated by a washout period of 3 to 14 days. Patients will return for a follow-up visit 26 to 30 days after the last study treatment.</p></div>"^^rdf:XMLLiteral ]         ]       ] [
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fhir:title [ fhir:v "Trial Schema" ] ;
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fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>(image removed) <strong>Figure IGBJ.1. Illustration of study design for Protocol I8R-JE-IGBJ.</strong> </p>\n<p>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 &lt;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.</p></div>"^^rdf:XMLLiteral ]       ]     ] [
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