## Protocol Section
### Identification Module
**NCT ID:** NCT03421379

**Brief Title:** A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus

**Official 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

#### Organization Study ID Info
**ID:** 16962
#### Organization
**Class:** INDUSTRY
**Full Name:** Eli Lilly and Company
#### Secondary ID Infos
**Domain:** Eli Lilly and Company
**ID:** I8R-JE-IGBJ
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2018-08-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-10-08

**Type:** ACTUAL

**Last Update Submit Date:** 2019-09-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-08-20

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-10-08

**Type:** ACTUAL

**Results First Submit Date:** 2019-08-14

**Results First Submit QC Date:** 2019-09-18

#### Start Date
**Date:** 2018-02-21

**Type:** ACTUAL

**Status Verified Date:** 2019-09

#### Study First Post Date
**Date:** 2018-02-05
**Type:** ACTUAL
**Study First Submit Date:** 2018-01-30
**Study First Submit QC Date:** 2018-01-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Eli Lilly and Company

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to determine the efficacy and safety of nasal glucagon compared to intramuscular (IM) glucagon for treatment of insulin-induced hypoglycemia in Japanese participants with diabetes mellitus.

### Conditions Module

**Conditions:**

- Diabetes Mellitus

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 75

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally.

**Intervention Names:**

- Drug: Glucagon Nasal Powder

**Label:** Glucagon Nasal Powder

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)

**Intervention Names:**

- Drug: Glucagon Hydrochloride Solution

**Label:** Glucagon Hydrochloride Solution

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Glucagon Nasal Powder

**Description:** Administered intranasally

**Name:** Glucagon Nasal Powder

**Other Names:**

- LY900018

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Glucagon Hydrochloride Solution

**Description:** Administered IM

**Name:** Glucagon Hydrochloride Solution

**Other Names:**

- GlucaGen®

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Percentage of participants who achieved treatment success during the controlled insulin-induced hypoglycemia in participants with type 1 diabetes mellitus (T1DM) and participants with type 2 diabetes mellitus (T2DM).Treatment success is defined as an increase in plasma glucose to greater than or equal to (≥) 70 milligrams per deciliter (mg/dL) or an increase of ≥20 mg/dL from plasma glucose nadir, without receiving additional actions to increase the plasma glucose concentration. Nadir is defined as the minimum plasma glucose concentration at the time of or within 10 minutes following glucagon administration.

**Measure:** Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia

**Time Frame:** Pre-dose up to 30 minutes post each glucagon administration

#### Secondary Outcomes

**Description:** PD assessment measured the change from Baseline in maximal blood glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride intramuscular (IM).

**Measure:** Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)

**Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration

**Description:** PD assessment measured the time to maximal concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM.

**Measure:** PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM

**Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration

**Description:** PK assessment measured the change from baseline in the area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of Glucagon Nasal Powder and Glucagon Hydrochloride IM.

**Measure:** 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

**Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration

**Description:** PK assessment measured the change from baseline in maximal concentration (Cmax) of glucagon nasal powder and glucagon hydrochloride IM.

**Measure:** PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM

**Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration

**Description:** PK assessment measured the change from baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM.

**Measure:** PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM

**Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)
* Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or 18.5 to 35.0 kg/m2 for T2D
* Hemoglobin A1c (HbA1c) ≤10%

Exclusion Criteria:

* Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month
* Have received a total daily dose of insulin \>1.2 units per kilogram (U/kg)

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Fukuoka

**Country:** Japan

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 812-0025

**Location 2:**

**City:** Tokyo

**Country:** Japan

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 130-0004

**Location 3:**

**City:** Tokyo

**Country:** Japan

**Facility:** For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

**Zip:** 162-0053

**Location 4:**

**City:** Tokyo

**Country:** Japan

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 169-0073

#### Overall Officials

**Official 1:**

**Affiliation:** Eli Lilly and Company

**Name:** Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Access Criteria:** A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

**Description:** Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- CSR

**IPD Sharing:** YES

**Time Frame:** Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

**URL:** https://www.clinicalstudydatarequest.com

## Document Section

### Large Document Module

#### Large Docs

- Date: 2017-12-05

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 684592

- Type Abbrev: Prot

- Upload Date: 2019-07-10T15:01

- Date: 2018-02-02

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 444216

- Type Abbrev: SAP

- Upload Date: 2019-07-10T15:01

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M10053

- Name: Hypoglycemia

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

### Intervention Browse Module - Ancestors

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000054795

- Term: Incretins

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M9043

- Name: Glucagon

- Relevance: HIGH

- As Found: Cluster

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M26997

- Name: Glucagon-Like Peptide 1

- Relevance: HIGH

- As Found: Cluster

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M27905

- Name: Incretins

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000005934

- Term: Glucagon

- ID: D000052216

- Term: Glucagon-Like Peptide 1

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** All randomized participants who received at least one dose of study drug.

#### Event Groups

**Group ID:** EG000

**Title:** Glucagon Nasal Powder

**Deaths Num At Risk:** 71

**Description:** A single dose of 3 mg glucagon nasal powder was administered intranasally

**ID:** EG000

**Other Num Affected:** 15

**Other Num at Risk:** 71

**Serious Number At Risk:** 71

**Title:** Glucagon Nasal Powder

**Group ID:** EG001

**Title:** Glucagon Hydrochloride Solution

**Deaths Num At Risk:** 70

**Description:** A single dose of 1 mg glucagon hydrochloride solution was administered IM

**ID:** EG001

**Other Num Affected:** 13

**Other Num at Risk:** 70

**Serious Number Affected:** 1

**Serious Number At Risk:** 70

**Title:** Glucagon Hydrochloride Solution

**Frequency Threshold:** 0

#### Other Events

**Term:** Ear pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Eye pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Eye pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Lacrimation increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Toothache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Feeling abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Cystitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

**Term:** Blood pressure decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 18.1

**Term:** Blood pressure increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 18.1

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Nasal congestion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Nasal pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Oropharyngeal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Rhinalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Cold sweat

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Hot flush

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 18.1

**Term:** Peripheral coldness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 18.1

#### Serious Events

**Term:** Vertigo positional

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 71

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 70

**Num Events:** 1

**Time Frame:** From Baseline to End of Follow-up (Up to 2 Months)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 33

**Group ID:** BG001

**Value:** 39

**Group ID:** BG002

**Value:** 72

**Units:** Participants

### Group

**ID:** BG000

**Title:** Glucagon Nasal Powder/Glucagon Hydrochloride Solution

**Description:** A single dose of 3 mg glucagon nasal powder was administered intranasally

### Group

**ID:** BG001

**Title:** Glucagon Hydrochloride Solution/Glucagon Nasal Powder

**Description:** A single dose of 1 mg glucagon hydrochloride solution was administered IM

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 11.6

**Value:** 41.7

#### Measurement

**Group ID:** BG001

**Spread:** 9.2

**Value:** 57.5

#### Measurement

**Group ID:** BG002

**Spread:** 13.0

**Value:** 50.2

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 22

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 20

#### Measurement

**Group ID:** BG001

**Value:** 30

#### Measurement

**Group ID:** BG002

**Value:** 50

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 33

#### Measurement

**Group ID:** BG001

**Value:** 39

#### Measurement

**Group ID:** BG002

**Value:** 72

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 33

#### Measurement

**Group ID:** BG001

**Value:** 39

#### Measurement

**Group ID:** BG002

**Value:** 72

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 33

#### Measurement

**Group ID:** BG001

**Value:** 39

#### Measurement

**Group ID:** BG002

**Value:** 72

**Class Title:** Japan

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
**Population Description:** All randomized participants who received at least one dose of study drug.
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** GT60
**Restrictive Agreement:** True
### Point of Contact
**Email:** ClinicalTrials.gov@lilly.com
**Organization:** Eli Lilly and Company
**Phone:** 800-545-5979
**Title:** Chief Medical Officer
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -1.47
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.47
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** The pre-defined non-inferiority margin is (10%)
**Non-Inferiority Type:** NON_INFERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Treatment Difference Wald's Method
**Parameter Value:** 0.00
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 32
- **Upper Limit:** 
- **Value:** 113
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 33
- **Upper Limit:** 
- **Value:** 119
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.50
- **Spread:** 
- **Upper Limit:** 4.02
- **Value:** 1.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.67
- **Spread:** 
- **Upper Limit:** 4.00
- **Value:** 1.50
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 89
- **Upper Limit:** 
- **Value:** 4830
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 32
- **Upper Limit:** 
- **Value:** 3240
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 103
- **Upper Limit:** 
- **Value:** 9520
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 37
- **Upper Limit:** 
- **Value:** 3290
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.17
- **Spread:** 
- **Upper Limit:** 0.67
- **Value:** 0.25
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.08
- **Spread:** 
- **Upper Limit:** 0.67
- **Value:** 0.17
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Percentage of participants who achieved treatment success during the controlled insulin-induced hypoglycemia in participants with type 1 diabetes mellitus (T1DM) and participants with type 2 diabetes mellitus (T2DM).Treatment success is defined as an increase in plasma glucose to greater than or equal to (≥) 70 milligrams per deciliter (mg/dL) or an increase of ≥20 mg/dL from plasma glucose nadir, without receiving additional actions to increase the plasma glucose concentration. Nadir is defined as the minimum plasma glucose concentration at the time of or within 10 minutes following glucagon administration.
**Parameter Type:** NUMBER
**Population Description:** All randomized participant who completed both treatment visits and had evaluable treatment success data.
**Reporting Status:** POSTED
**Time Frame:** Pre-dose up to 30 minutes post each glucagon administration
**Title:** Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** A single dose of 3 mg glucagon nasal powder was administered intranasally
**ID:** OG000
**Title:** Glucagon Nasal Powder
##### Group
**Description:** A single dose of 1 mg glucagon hydrochloride solution was administered IM
**ID:** OG001
**Title:** Glucagon Hydrochloride Solution
#### Outcome Measure 2
**Description:** PD assessment measured the change from Baseline in maximal blood glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride intramuscular (IM).
**Dispersion Type:** Geometric Coefficient of Variation
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All randomized patients who receive at least 1 dose of the study drug and have evaluable PD data.
**Reporting Status:** POSTED
**Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration
**Title:** Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)
**Type:** SECONDARY
**Unit of Measure:** milligram/deciliter (mg/dL)
##### Group
**Description:** A single dose of 3 mg glucagon nasal powder was administered intranasally
**ID:** OG000
**Title:** Glucagon Nasal Powder
##### Group
**Description:** A single dose of 1 mg glucagon hydrochloride solution was administered IM
**ID:** OG001
**Title:** Glucagon Hydrochloride Solution
#### Outcome Measure 3
**Description:** PD assessment measured the time to maximal concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM.
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** All randomized participants who received at least one dose of study drug and had evaluable PD data.
**Reporting Status:** POSTED
**Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration
**Title:** PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM
**Type:** SECONDARY
**Unit of Measure:** hour
##### Group
**Description:** A single dose of 3 mg glucagon nasal powder was administered intranasally
**ID:** OG000
**Title:** Glucagon Nasal Powder
##### Group
**Description:** A single dose of 1 mg glucagon hydrochloride solution was administered IM
**ID:** OG001
**Title:** Glucagon Hydrochloride Solution
#### Outcome Measure 4
**Description:** PK assessment measured the change from baseline in the area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of Glucagon Nasal Powder and Glucagon Hydrochloride IM.
**Dispersion Type:** Geometric Coefficient of Variation
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All randomized participants who received at least one dose of study drug and had evaluable PK data.
**Reporting Status:** POSTED
**Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration
**Title:** 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
**Type:** SECONDARY
**Unit of Measure:** Picogram*hour/milliliter (pg*h/mL)
##### Group
**Description:** A single dose of 3 mg glucagon nasal powder was administered intranasally
**ID:** OG000
**Title:** Glucagon Nasal Powder
##### Group
**Description:** A single dose of 1 mg glucagon hydrochloride solution was administered IM
**ID:** OG001
**Title:** Glucagon Hydrochloride Solution
#### Outcome Measure 5
**Description:** PK assessment measured the change from baseline in maximal concentration (Cmax) of glucagon nasal powder and glucagon hydrochloride IM.
**Dispersion Type:** Geometric Coefficient of Variation
**Parameter Type:** GEOMETRIC_MEAN
**Population Description:** All randomized participants who received at least one dose of study drug and had evaluable PK data.
**Reporting Status:** POSTED
**Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration
**Title:** PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM
**Type:** SECONDARY
**Unit of Measure:** picogram/milliliter (pg/mL)
##### Group
**Description:** A single dose of 3 mg glucagon nasal powder was administered intranasally
**ID:** OG000
**Title:** Glucagon Nasal Powder
##### Group
**Description:** A single dose of 1 mg glucagon hydrochloride solution was administered IM
**ID:** OG001
**Title:** Glucagon Hydrochloride Solution
#### Outcome Measure 6
**Description:** PK assessment measured the change from baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM.
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** All randomized participants who received at least one dose of study drug and had evaluable PK data.
**Reporting Status:** POSTED
**Time Frame:** Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration
**Title:** PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM
**Type:** SECONDARY
**Unit of Measure:** hour (h)
##### Group
**Description:** A single dose of 3 mg glucagon nasal powder was administered intranasally
**ID:** OG000
**Title:** Glucagon Nasal Powder
##### Group
**Description:** A single dose of 1 mg glucagon hydrochloride solution was administered IM
**ID:** OG001
**Title:** Glucagon Hydrochloride Solution
### Participant Flow Module
#### Group
**Description:** A single dose of 3 milligram (mg) glucagon nasal powder was administered intranasally in period 1 then 1 mg single dose intramuscular glucagon hydrochloride solution was administered in period 2.
**ID:** FG000
**Title:** Glucagon Nasal Powder/Glucagon Hydrochloride
#### Group
**Description:** A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM) in period 1 then 3 mg single dose glucagon nasal powder was administered in period 2.
**ID:** FG001
**Title:** Glucagon Hydrochloride Solution/Glucagon Nasal Powder
#### Period
**Title:** Period 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Did not receive treatment
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 34
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 41
##### Milestone
**Type:** Received at Least One Dose of Study Drug
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 33
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 39
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 32
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 37
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 4
#### Period
**Title:** Washout Period (3 to 14 Days)
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 32
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 37
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 32
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 37
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
#### Period
**Title:** Period 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 32
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 37
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 32
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 37
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Pre-Assignment Details:** Participants were randomized to receive either nasal glucagon or intramuscular (IM) glucagon in the first period, followed by the alternate treatment in the second period.
**Has Results:** True