A Study of Single or Repeated Doses of Glucagon in Partic... | NCT02806973

NCT02806973

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description
I8R-MC-IGBG	Other Identifier	Eli Lilly and Company
AMG112	Other Identifier	Algorithme Pharma
AGL-P5-310	Other Identifier	Algorithme Pharma

Status Module

Name	Class
Locemia Solutions ULC	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nasal Glucagon (NG) - Treatment 1	Experimental	One dose of 3 milligram (mg) NG administered in one of four study periods.	Drug: Nasal Glucagon
NG - Treatment 2	Experimental	Two NG doses, 3 mg each dose, administered 15 minutes apart, in the same nostril, in one of four study periods.	Drug: Nasal Glucagon
NG - Treatment 3	Experimental	Two NG doses, 3 mg each dose, administered 15 minutes apart, in opposite nostrils, in one of four study periods.	Drug: Nasal Glucagon
NG - Treatment 4	Experimental	Two NG doses, 3 mg each dose, administered one immediately after the other, in opposite nostrils, in one of four study periods.	Drug: Nasal Glucagon

Name	Type	Description	Arm Group Labels	Other Names
Nasal Glucagon	Drug	Administered intranasally.	NG - Treatment 2 NG - Treatment 3 NG - Treatment 4 Nasal Glucagon (NG) - Treatment 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T(AUC[0-tlast]) of Baseline-Adjusted Glucagon		-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon		-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon		-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration
Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC0-3) of Baseline-Adjusted Glucose From Time Zero up to 3 Hours		-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose		-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration
PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax)		-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration

Other Outcomes

Measure	Description	Time Frame
PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Glucagon		-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female with a history of Type 1 or Type 2 insulin-using diabetes of at least 1 year duration (basal only, basal bolus, meal-time only, or twice a day pre-mixed insulin)
A female participant must meet one of the following criteria:
- Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first administration of the study drug, during the study and for at least 30 days after the last dose of the study drug
- Participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses)
Participant with a body mass index (BMI) greater than or equal to 18.50 kilograms per square meter (kg/m²) and below 35.00 kg/m²
Light-, non- or ex-smokers
In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the Investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations

Exclusion Criteria:

Females who are pregnant, actively attempting to get pregnant, or are lactating
History of significant hypersensitivity to glucagon or any related products as well as severe hypersensitivity reactions (such as angioedema) to any drugs
Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
Known presence of rare hereditary problems of galactose and /or lactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Presence of clinically significant findings on nasal examination or bilateral anterior rhinoscopy, such as structural abnormalities, nasal polyps, marked septal deviation, nasal tumors
Nasal surgery in the previous 28 days before Day 1 of this study
Daily use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this study
Any other concomitant maintenance therapy that would influence the outcome of the trial or compromise the safety of the participant, at the discretion of the Investigator and the Sponsor, in the previous 28 days before Day 1 of this study
Significant history of drug dependency or alcohol abuse
Any clinically significant illness in the previous 28 days before Day 1 of this study
Any history of tuberculosis and/or prophylaxis for tuberculosis
Positive urine screening of alcohol and/or drugs of abuse
Positive results to human immunodeficiency virus (HIV) Antigen/Antibody (Ag/Ab) Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or anti-Hepatitis C Virus (HCV (C)) tests
Concurrent participation or intention of participating in another clinical trial during this study
Participants who took an Investigational Product (in another clinical trial) in the previous 28 days before Day 1 of this study or who have already participated in this clinical study
Participants who donated 50 milliliters (mL) or more of blood in the previous 28 days before Day 1 of this study
Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before Day 1 of this study

Name	Affiliation	Role
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)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
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.		Mount Royal	Quebec	H3P 3P1

Arm/Group Information

ID	Title	Description
FG000	Sequence 1 (T1/T2/T3/T4)	Treatment 1 (T1) = Single NG dose of 3 milligram (mg), T2 = NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later, T3 = NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later, T4 = NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril.
FG001	Sequence 2 (T2/T3/T4/T1)	T2 = NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later , T3 = NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later, T4 = NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril, T1 = Single NG dose of 3 mg.
FG002	Sequence 3 (T3/T4/T1/T2)	T3 = NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later, T4 = NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril, T1 = Single NG dose of 3 mg, T2 = NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later.
FG003	Sequence 4 (T4/T1/T2/T3)	T4 = NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril, T1 = Single NG dose of 3 mg, T2 = NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later, T3 = NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later.

ID	Title	Description
BG000	Nasal Glucagon	All enrolled participants.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T(AUC[0-tlast]) of Baseline-Adjusted Glucagon

All enrolled participants with evaluable PK data.

Posted

Mean

Standard Deviation

picogram*hour per millilitre (pg*hr/mL)

-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration

ID	Title	Description
OG000	Nasal Glucagon Treatment 1	One dose of nasal glucagon.
OG001	Nasal Glucagon - Treatment 2	Two doses of nasal glucagon, 15 minutes apart, in the same nostril.
OG002

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nasal Glucagon Treatment 1	One dose of nasal glucagon.

ID	Term
D003922	Diabetes Mellitus, Type 1
D003924	Diabetes Mellitus, Type 2

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases