Type 1 DiabetesPhase 1RescuiNGkidsNCT04992312

A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes

A Phase 1 study testing Glucagon Nasal Powder [Baqsimi] in people with Type 1 Diabetes, run by Eli Lilly and Company at 8 sites 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 1 year to 4 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: Glucagon Nasal Powder [Baqsimi]
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 8 sitesUnited States
Study dates: 24 Mar 2022to 5 Nov 2023
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 1 year to 4 years
All sexes
No healthy volunteers
Child

Who may be able to join

Have a Type 1 Diabetes diagnosis for at least 6 months
Have been receiving insulin therapy via multiple daily injections or using an insulin pump and have been stable for at least 3 months prior to screening
Have a HbA1c level of ≤ 9.5% at screening
Have sufficient venous access for collection of blood samples
Have good general health, apart from their Type 1 diabetes, with no prior history of choanal atresia, nasal/pharyngeal blockage or nasal anomaly

Who cannot join

Have a presence or history of glucagon hypersensitivity
Have a history of pheochromocytoma
Have a history of epilepsy or seizure disorder
Have 1 or more congenital anomalies to the anatomy of the nose, or require changes to the anatomy of the nose
Are using closed-loop insulin therapy, unless such a device is set to 'open loop/manual' mode on the day of the dosing visit
Have an episode of severe hypoglycemia or have had glucagon administered , during the 3 months prior to the screening visit and no severe hypoglycemia between the screening and dosing visit

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

St. Luke's Regional Medical Center
Boise, Idaho, 83712
UBMD Pediatrics
Buffalo, New York, 14203
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
Riley Hospital for Children
Indianapolis, Indiana, 46202
Nemours Childrens Clinic
Jacksonville, Florida, 32207
Children's Mercy Hospital
Kansas City, Missouri, 64108
University of Minnesota Medical School
Minneapolis, Minnesota, 55454
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: An Open-Label, Multi-Center, Single-Dose Study to Assess the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Nasal Glucagon in Pediatric Patients With Type 1 Diabetes Aged 1 to <4 Years

The main purpose of this study is to evaluate the safety and tolerability of a study drug called nasal glucagon (Baqsimi) in pediatric participants with type 1 diabetes (T1D) aged 1 to less than 4 years. Blood tests will be performed to check how much nasal glucagon gets into the bloodstream. Blood sugar will also be measured to understand the effect of the drug on blood sugar levels. The study consists of a screening period up to 35 days before dosing, 1 day when a dose of nasal glucagon will be given and then 2 telephone follow up calls; first follow-up call on the day after the nasal glucagon was given and second call about one week after nasal glucagon was given. The study will last up to 9 days, not including the screening period.

Conditions: Type 1 Diabetes
Being tested: Glucagon Nasal Powder [Baqsimi]
Keywords: Severe Hypoglycemia, Nasal Powder, Hypoglycemia Rescue Therapy, Ready to use Glucagon
Medical subject headings: Diabetes Mellitus, Type 1, Hypoglycemia

What participants receive

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

Glucagon Nasal Powder [Baqsimi]Drug
Also called LY900018, Baqsimi
Administered intranasally

Study groups in NCT04992312
Study group	Role	What they receive
3 milligram (mg) Nasal Glucagon	Experimental	Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1. Receives: Drug: Glucagon Nasal Powder [Baqsimi]

What is being measured

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

Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A TEAE is defined as an adverse event which occurs post-dose or which is present prior to dosing and becomes more severe post-dose. An SAE is any AE from the study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more TEAEs, SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.
Measured: Baseline to Day 9

Secondary outcomes (5)

Pharmacodynamics (PD): Change From Baseline in Maximum Observed Blood Glucose (BGmax)
Change from baseline in BGmax was measured to investigate the PD effect of nasal glucagon on blood glucose level following 3 mg nasal glucagon administration on day 1. Baseline is defined as Day 1 pre-dose. The BGmax on Day 1 was determined using plasma samples collected pre-dose, 10, 30, 60, and 90 minutes post nasal glucagon dose.
Measured: Baseline, Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
PD: Absolute BGmax of Nasal Glucagon
PD: Absolute BGmax of Nasal Glucagon
Measured: Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon
PD: TBGmax of Nasal Glucagon
Measured: Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose
AUC from time 0 to the last measured concentration of blood glucose at 90 minutes [AUC(0-90)] is reported.
Measured: Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
Pharmacokinetics (PK): AUC of Nasal Glucagon
PK: AUC of Nasal Glucagon
Measured: Day 1 (10, 30, 60 minutes post-dose)

Timeline

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

24 Mar 20225 Nov 2023

First posted5 Aug 2021
Study start24 Mar 2022
Primary completion5 Nov 2023
Study completion5 Nov 2023

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 Type 1 DiabetesStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04992312
Sponsor's protocol ID: 17449
Other IDs: I8R-MC-IGBO, 2021-006088-61
Acronym: RescuiNGkids
Status last verified: May 2024
First submitted: 4 Aug 2021
Last updated: 23 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multi-Center, Single-Dose Study to Assess the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Nasal Glucagon in Pediatric Patients With Type 1 Diabetes Aged 1 to <4 Years
ClinicalTrials.gov ID: NCT04992312
Acronym / sponsor ID: RescuiNGkids / 17449
Conditions: Type 1 Diabetes
Keywords: Severe Hypoglycemia, Nasal Powder, Hypoglycemia Rescue Therapy, Ready to use Glucagon
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 24 Mar 2022 (actual)
Primary completion: 5 Nov 2023 (actual)
Study completion: 5 Nov 2023 (actual)
First posted: 5 Aug 2021 (actual)
Results: Posted 23 May 2024

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
3 milligram (mg) Nasal Glucagon	Experimental	Drug: Glucagon Nasal Powder [Baqsimi]Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1.

Who may qualify

Ages: 1 year to 4 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Have a Type 1 Diabetes diagnosis for at least 6 months
Have been receiving insulin therapy via multiple daily injections or using an insulin pump and have been stable for at least 3 months prior to screening
Have a HbA1c level of ≤ 9.5% at screening
Have sufficient venous access for collection of blood samples
Have good general health, apart from their Type 1 diabetes, with no prior history of choanal atresia, nasal/pharyngeal blockage or nasal anomaly

Key exclusion criteria (6 listed)

Have a presence or history of glucagon hypersensitivity
Have a history of pheochromocytoma
Have a history of epilepsy or seizure disorder
Have 1 or more congenital anomalies to the anatomy of the nose, or require changes to the anatomy of the nose
Are using closed-loop insulin therapy, unless such a device is set to 'open loop/manual' mode on the day of the dosing visit

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
Glucagon Nasal Powder [Baqsimi]Also: LY900018, BaqsimiAdministered intranasally	Drug	3 milligram (mg) Nasal Glucagon

Primary outcome

Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline to Day 9
A TEAE is defined as an adverse event which occurs post-dose or which is present prior to dosing and becomes more severe post-dose. An SAE is any AE from the study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more TEAEs, SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.

5 secondary outcomes

Pharmacodynamics (PD): Change From Baseline in Maximum Observed Blood Glucose (BGmax)
Time frame: Baseline, Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
PD: Absolute BGmax of Nasal Glucagon
Time frame: Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon
Time frame: Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose
Time frame: Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
Pharmacokinetics (PK): AUC of Nasal Glucagon
Time frame: Day 1 (10, 30, 60 minutes post-dose)

Results and safety

Results posted to the registry on 23 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3 Milligram (mg) Nasal Glucagon	7	7

Primary outcome: Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame: Baseline to Day 9. Count of participants. Unit: Participants

Measure	3 mg Nasal Glucagon n = 7
TEAEs	5
SAEs	0

Population analysed: All participants who received at least one dose of study drug.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to Day 9. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3 mg Nasal Glucagon	0 of 7 (0%)	5 of 7 (71.4%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes (RescuiNGkids)Link provided by the sponsor.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Glucagon Nasal Powder [Baqsimi] in people with Type 1 Diabetes, run by Eli Lilly and Company at 8 sites 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 5 inclusion and 6 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 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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 23 May 2024). 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 Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline to Day 9). 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 NCT04992312.

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 23 May 2024.