HealthyPhase 1NCT03765502

A Study Comparing User Experience of Different Delivery Devices for Glucagon

A Phase 1 study testing Nasal Glucagon Device (NG), GEK and IM Glucagon in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Nasal Glucagon Device (NG), GEK and IM Glucagon
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 99 participants
Where: 1 siteUnited States
Study dates: 19 Nov 2018to 3 Jan 2019
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All participants (Trained Users, Participants with Diabetes [PWDs] and Untrained Users):
Are able to understand the purpose and procedure of the study and to give written informed consent to show willingness to participate in the study
Trained Users only:
Are participants who are not diagnosed with Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM)
Are close friends/relatives of a patient with T1DM or T2DM on insulin
Have not previously administered any rescue medications (e.g. epinephrine, glucagon, narcan or seizure medications)

Show all 9Show fewer

Untrained Users only:
Have not been diagnosed with T1DM or T2DM, and are not a Trained User of a person with T1DM or T2DM
Have not previously administered any rescue medications (e.g. epinephrine, glucagon, narcan or seizure medications)

Who cannot join

All participants (Trained Users, PWDs and Untrained Users):
In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
Trained Users and Untrained Users only (i.e. the participants involved in the simulations):
Are currently enrolled in a clinical study involving any type of medical research judged not to be scientifically or medically compatible with this study
Are judged by the investigator as being likely to have difficulty performing the administration due to physical, cognitive and/or severe psychiatric disorder
Are judged by the investigator as being trained or experienced in performing rescue drug administration
Are judged by the investigator as being trained or experienced in performing high-fidelity simulations of drug administration
Have received formal training in a medical field, and/or worked in this field within the prior 5 years; or otherwise are judged by the investigator as being trained or experienced as a first responder

Trial locations and contacts

1 site in 1 country.

United States1 site

High Point Clinical Trials Center
High Point, North Carolina, 27265

Other trials in United States

About this study

Official title: A Simulation Study Comparing Successful Administration, Time to Administer, and User Experience of Ready-to-Use Nasal Glucagon With Reconstitutable Injectable Glucagon

The purpose of the study is to learn more about different devices for delivering glucagon during simulations of severe hypoglycemic (low blood sugar) emergencies. The study will be carried out using medical manikins to simulate real life scenarios. No drug will be administered to humans. Part A will last approximately 17 days for Trained Users and Participants with Diabetes (PWD). Part B will last approximately nine (9) days for Untrained Users. Each part will be separated by approximately 7 days.

Conditions: Healthy
Being tested: Nasal Glucagon Device (NG), GEK, IM Glucagon

What participants receive

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

Nasal Glucagon Device (NG)Device
NG devices will be provided empty of drug product
GEKDevice
Used to administer glucagon intramuscularly (IM)
IM GlucagonDrug
Administered IM via GEK

Study groups in NCT03765502
Study group	Role	What they receive
Nasal Glucagon Device (NG)	Experimental	Empty NG device administered to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans. Receives: Device: Nasal Glucagon Device (NG)
Glucagon Emergency Kit (GEK)	Active comparator	Commercially available GEK delivered intramuscularly to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans. Receives: Device: GEK; Drug: IM Glucagon

What is being measured

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

Percentage of Trained Users That Performed a Successful Administration for Each Device
Percentage of trained users who found both devices and performed a successful administration of both rescue devices for both simulations.
Measured: Part A: Days 8 - 9 and Days 15 - 17

Secondary outcomes (6)

Percentage of Untrained Users That Perform a Successful Administration for Each Device
Percentage of untrained users who found both devices and performed a successful administration of both rescue devices for both simulations.
Measured: Part B: Day 1 and Days 8-9
Average Time for Trained Users to Successfully Administer One Device Over the Other
Average time for trained users who found both devices to successfully administer one rescue device over the other in Part A.
Measured: Part A: Day 8 and Days 15-17
Average Time for Untrained Users to Successfully Administer One Device Over the Other
Average time for untrained users who found both devices to successfully administer one rescue device over the other in Part B. To successfully administer either NG or GEK, a participant must complete all of the critical steps for each device, and administer a complete dose.
Measured: Part B: Day 1 and Days 8-9
Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other
Overall preference was measured via the Rescue Device Preference (RDP) questionnaire completed by Trained and Untrained participant users. Participants rated their preference for NG or GEK by choosing one of five radio buttons: Strongly prefer NG, prefer NG, no preference, prefer GEK, strongly prefer GEK. Data here represents pooling for Part A and Part B.
Measured: Part A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9
Percentage of Participants (PWD) That Prefer One Device Over the Other
Preference was measured by the PWD overall feeling of being safer during a severe low blood sugar event using Rescue Device Preference-Associated Person (RDP-AP). Participants rated their preference for NG or GEK by choosing one of five radio buttons: Strongly prefer NG, prefer NG, no preference, prefer GEK, strongly prefer GEK.
Measured: Part A: Days 15 - 17
Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other
Ease of use was measured via the Individual Rescue Device Ease of Use (RDEU) Questionnaire by Trained and Untrained Participants. Participants answered three questions about ease of use for each device by choosing one of five radio buttons: Strongly disagree, disagree, neither disagree nor agree, agree, strongly agree. Data here represents pooling of Simulation 1 for Part A and Part B.
Measured: Part A: Days 15 -17 and Part B: Days 8 - 9

Timeline

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

19 Nov 20183 Jan 2019

First posted5 Dec 2018
Study start19 Nov 2018
Primary completion3 Jan 2019
Study completion3 Jan 2019

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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03765502
Sponsor's protocol ID: 17156
Other IDs: I8R-MC-IGBM
Status last verified: Jun 2019
First submitted: 16 Nov 2018
Last updated: 20 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: 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 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Simulation Study Comparing Successful Administration, Time to Administer, and User Experience of Ready-to-Use Nasal Glucagon With Reconstitutable Injectable Glucagon
ClinicalTrials.gov ID: NCT03765502
Acronym / sponsor ID: 17156
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 19 Nov 2018 (actual)
Primary completion: 3 Jan 2019 (actual)
Study completion: 3 Jan 2019 (actual)
First posted: 5 Dec 2018 (actual)
Results: Posted 20 Mar 2020

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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Nasal Glucagon Device (NG)	Experimental	Device: Nasal Glucagon Device (NG)Empty NG device administered to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.
Glucagon Emergency Kit (GEK)	Active comparator	Device: GEK, Drug: IM GlucagonCommercially available GEK delivered intramuscularly to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

All participants (Trained Users, Participants with Diabetes [PWDs] and Untrained Users):
Are able to understand the purpose and procedure of the study and to give written informed consent to show willingness to participate in the study
Are participants who are not diagnosed with Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM)
Are close friends/relatives of a patient with T1DM or T2DM on insulin
Have not previously administered any rescue medications (e.g. epinephrine, glucagon, narcan or seizure medications)

Key exclusion criteria (8 listed)

In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
Trained Users and Untrained Users only (i.e. the participants involved in the simulations):
Are currently enrolled in a clinical study involving any type of medical research judged not to be scientifically or medically compatible with this study
Are judged by the investigator as being likely to have difficulty performing the administration due to physical, cognitive and/or severe psychiatric disorder
Are judged by the investigator as being trained or experienced in performing rescue drug administration

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 Glucagon Device (NG)NG devices will be provided empty of drug product	Device	Nasal Glucagon Device (NG)
GEKUsed to administer glucagon intramuscularly (IM)	Device	Glucagon Emergency Kit (GEK)
IM GlucagonAdministered IM via GEK	Drug	Glucagon Emergency Kit (GEK)

Primary outcome

Percentage of Trained Users That Performed a Successful Administration for Each Device
Time frame: Part A: Days 8 - 9 and Days 15 - 17
Percentage of trained users who found both devices and performed a successful administration of both rescue devices for both simulations.

6 secondary outcomes

Percentage of Untrained Users That Perform a Successful Administration for Each Device
Time frame: Part B: Day 1 and Days 8-9
Average Time for Trained Users to Successfully Administer One Device Over the Other
Time frame: Part A: Day 8 and Days 15-17
Average Time for Untrained Users to Successfully Administer One Device Over the Other
Time frame: Part B: Day 1 and Days 8-9
Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other
Time frame: Part A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9
Percentage of Participants (PWD) That Prefer One Device Over the Other
Time frame: Part A: Days 15 - 17
Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other
Time frame: Part A: Days 15 -17 and Part B: Days 8 - 9

Results and safety

Results posted to the registry on 20 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A Trained Users NG/GEK	20	20
Part A Trained Users GEK/NG	13	13
Part A Person With Diabetes (PWD)	33	33
Part B Untrained Users NG/GEK	16	16
Part B Untrained Users GEK/NG	17	17

Primary outcome: Percentage of Trained Users That Performed a Successful Administration for Each Device

Time frame: Part A: Days 8 - 9 and Days 15 - 17. Number. Unit: percentage of participants

Measure	Nasal Glucagon (NG) n = 31	Glucagon Emergency Kit (GEK) n = 32
Value	90.3	15.6

Nasal Glucagon (NG) vs Glucagon Emergency Kit (GEK): p <.0001, McNemar

Population analysed: All trained user participants who found both devices and participated in at least one simulation of a rescue device. Participants with diabetes (PWD) reporting group data not collected per protocol.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to end of study (up to 17 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A Trained Users Nasal Glucagon (NG)	0 of 33 (0%)	0 of 33 (0%)	0 of 33
Part A Trained Users Glucagon Emergency Kit (GEK)	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Part A Participants With Diabetes (PWD)	0 of 33 (0%)	0 of 33 (0%)	0 of 33
Part B Untrained Users NG	0 of 33 (0%)	0 of 33 (0%)	0 of 33
Part B Untrained Users GEK	0 of 33 (0%)	0 of 33 (0%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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 Device (NG), GEK and IM Glucagon in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

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 9 inclusion and 8 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 20 Mar 2020. 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 United States. 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 20 Mar 2020). 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?

Percentage of Trained Users That Performed a Successful Administration for Each Device (time frame: Part A: Days 8 - 9 and Days 15 - 17). 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 NCT03765502.

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 20 Mar 2020.