HealthyPhase 1NCT02778113

A Study of Glucagon Administered in Different Forms and Routes to Healthy Adults

A Phase 1 study testing Nasal Glucagon and Glucagon in people with Healthy, run by Eli Lilly and Company at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this study was to evaluate the safety and tolerability of nasal glucagon (NG). The study drug was delivered into the participant's nostril (intranasally) or was given as an injection just under the skin (subcutaneously) once in each of four study periods. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Nasal Glucagon and Glucagon
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteCanada
Study dates: Oct 2011to Nov 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Body mass index (BMI) greater than or equal to 20.00 and below or equal to 28.00 kg/m².
Light-, non- or ex-smokers.
Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis).

Who cannot join

Presence of any nose piercings.
History of significant hypersensitivity to glucagon or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like 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.
Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease.
Presence of clinically significant findings on nasal examination and bilateral anterior rhinoscopy.
Fasting blood glucose above 5.0 millimoles per liter (mmol/L) at screening, following a 12-hour fasting period.
Fasting blood glucose assessed with a glucose meter above 5.5 mmol/L 0.5 hour before each dosing.

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

Official title: A Single Site, Randomized, Four-Way, Four-Period PK/PD Crossover Phase 1 Clinical Study in 16 Fasted Healthy Adult Volunteers Receiving 3 Dose Levels of Intranasally Administered Glucagon and One Dose Level of Glucagon Administered by Subcutaneous Injection

Conditions: Healthy
Being tested: Nasal Glucagon, Glucagon

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nasal GlucagonDrug
Also called AMG 504-1, LY900018
Administered intranasally.
GlucagonDrug
Administered SC.

Study groups in NCT02778113
Study group	Role	What they receive
Nasal Glucagon (NG) - 0.5 mg	Experimental	Ng dose at 0.5 milligram (mg) administered once in one of four study periods. Receives: Drug: Nasal Glucagon
NG - 1.0 mg	Experimental	Ng dose at 1.0 milligram (mg) administered once in one of four study periods. Receives: Drug: Nasal Glucagon
NG - 2.0 mg	Experimental	Ng dose at 2.0 milligram (mg) administered once in one of four study periods. Receives: Drug: Nasal Glucagon
SC Glucagon 1 mg	Active comparator	Subcutaneous (SC) glucagon dose of 1 mg, in one of four study periods. Receives: Drug: Glucagon

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With One or More Serious Adverse Event(s) (SAEs)
Safety and tolerability evaluated through the assessment of adverse events. A SAE (serious adverse event) was defined as any untoward medical occurrence in a clinical investigation, which did not necessarily have a causal relationship with this treatment.
A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Measured: Baseline through Study Completion (Day 23)

Secondary outcomes (7)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon
Measured: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon
Measured: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Measured: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
Measured: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀-₄) of Glucose
Measured: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Measured: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax)
Measured: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Nov 2011

First posted19 May 2016 (estimated)
Study startOct 2011
Primary completionOct 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02778113
Sponsor's protocol ID: 16424
Other IDs: I8R-MC-IGBD, AMG 101, GUO-P1-557
Status last verified: May 2016
First submitted: 18 May 2016
Last updated: 19 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Site, Randomized, Four-Way, Four-Period PK/PD Crossover Phase 1 Clinical Study in 16 Fasted Healthy Adult Volunteers Receiving 3 Dose Levels of Intranasally Administered Glucagon and One Dose Level of Glucagon Administered by Subcutaneous Injection
ClinicalTrials.gov ID: NCT02778113
Acronym / sponsor ID: 16424
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Locemia Solutions ULC
Study start: Oct 2011
Primary completion: Oct 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 19 May 2016 (estimated)
Results: Posted 19 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Nasal Glucagon (NG) - 0.5 mg	Experimental	Drug: Nasal GlucagonNg dose at 0.5 milligram (mg) administered once in one of four study periods.
NG - 1.0 mg	Experimental	Drug: Nasal GlucagonNg dose at 1.0 milligram (mg) administered once in one of four study periods.
NG - 2.0 mg	Experimental	Drug: Nasal GlucagonNg dose at 2.0 milligram (mg) administered once in one of four study periods.
SC Glucagon 1 mg	Active comparator	Drug: GlucagonSubcutaneous (SC) glucagon dose of 1 mg, in one of four study periods.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Body mass index (BMI) greater than or equal to 20.00 and below or equal to 28.00 kg/m².
Light-, non- or ex-smokers.
Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis).

Key exclusion criteria (7 listed)

Presence of any nose piercings.
History of significant hypersensitivity to glucagon or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like 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.
Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease.
Presence of clinically significant findings on nasal examination and bilateral anterior rhinoscopy.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nasal GlucagonAlso: AMG 504-1, LY900018Administered intranasally.	Drug	NG - 1.0 mg, NG - 2.0 mg, Nasal Glucagon (NG) - 0.5 mg
GlucagonAdministered SC.	Drug	SC Glucagon 1 mg

Primary outcome

Number of Participants With One or More Serious Adverse Event(s) (SAEs)
Time frame: Baseline through Study Completion (Day 23)
Safety and tolerability evaluated through the assessment of adverse events. A SAE (serious adverse event) was defined as any untoward medical occurrence in a clinical investigation, which did not necessarily have a causal relationship with this treatment. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

7 secondary outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon
Time frame: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon
Time frame: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Time frame: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
Time frame: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀-₄) of Glucose
Time frame: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Time frame: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax)
Time frame: Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment

Results and safety

Results posted to the registry on 19 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1 (T1/T2/T3/T4)	4	4
Sequence 2 (T2/T3/T4/T1)	4	4
Sequence 3 (T3/T4/T1/T2)	4	4
Sequence 4 (T4/T1/T2/T3)	4	4

Primary outcome: Number of Participants With One or More Serious Adverse Event(s) (SAEs)

Time frame: Baseline through Study Completion (Day 23). Count of participants. Unit: Participants

Measure	NG 0.5 mg n = 15	NG 1 mg n = 14	NG 2 mg n = 16	SC Glucagon 1 mg n = 15
Value	0	0	0	0

Population analysed: All randomized participants who entered study period four.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose of study drug (Day 1) until post-study completion (Day 23). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NG 0.5 mg	0 of 15 (0%)	2 of 15 (13.3%)	Not reported
NG 1 mg	0 of 14 (0%)	6 of 14 (42.9%)	Not reported
NG 2 mg	0 of 16 (0%)	8 of 16 (50%)	Not reported
SC Glucagon 1 mg	0 of 15 (0%)	6 of 15 (40%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nasal Glucagon and Glucagon in people with Healthy, run by Eli Lilly and Company at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With One or More Serious Adverse Event(s) (SAEs) (time frame: Baseline through Study Completion (Day 23)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02778113.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.