Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

Short name RescuiNGkids

NCTNCT04992312Other id17449Other idI8R-MC-IGBOOther id2021-006088-61

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 7 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 24 Mar 2022
Primary completion: 5 Nov 2023
Completion: 5 Nov 2023
First posted: 5 Aug 2021
Last update posted: 23 May 2024
Conditions: Type 1 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202220232024

Ph 1
RescuiNGkids
NCT04992312
24 Mar 2022 to 5 Nov 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Glucagon Nasal Powder [Baqsimi]Drug

Arms1

Experimental
3 milligram (mg) Nasal Glucagon
Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1.

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
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.

Secondary outcomes(5)

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)
Registry description
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.
PD: Absolute BGmax of Nasal Glucagon
Time frame · Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
Registry description
PD: Absolute BGmax of Nasal Glucagon
PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon
Time frame · Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
Registry description
PD: TBGmax of Nasal Glucagon
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)
Registry description
AUC from time 0 to the last measured concentration of blood glucose at 90 minutes \[AUC(0-90)\] is reported.
Pharmacokinetics (PK): AUC of Nasal Glucagon
Time frame · Day 1 (10, 30, 60 minutes post-dose)
Registry description
PK: AUC of Nasal Glucagon

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Baseline to Day 9

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

Group	Value (Participants)
3 mg Nasal Glucagon	5

Secondary and other outcome results(5)

Secondary outcomeMean· Baseline, Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)

Pharmacodynamics (PD): Change From Baseline in Maximum Observed Blood Glucose (BGmax)

Group	Value (milligrams per deciliter (mg/dL))	Spread
3 mg Nasal Glucagon	132.4	52.4

Secondary outcomeMean· Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)

PD: Absolute BGmax of Nasal Glucagon

Group	Value (mg/dL)	Spread
3 mg Nasal Glucagon	242.1	46

Secondary outcomeMean· Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)

PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon

Group	Value (minutes)	Spread
3 mg Nasal Glucagon	55.6	20.9

Secondary outcomeMean· Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)

PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose

Group	Value (milligramminute per deciliter (mgm/dL))	Spread
3 mg Nasal Glucagon	18200	3000

Secondary outcomeGeometric mean· Day 1 (10, 30, 60 minutes post-dose)

Pharmacokinetics (PK): AUC of Nasal Glucagon

Group	Value (picogramhour per milliliter (pghr/mL))	Spread
3 mg Nasal Glucagon	1560	25.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
3 mg Nasal GlucagonParticipants received a single dose of 3 mg glucagon powder administered intranasally on day 1.	0 / 7	0 / 7	5 / 7

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 1 Year up to 4 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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