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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Glucagon Nasal Powder [Baqsimi]


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucagon Nasal Powder<br>A single dose of glucagon nasal powder administered intranasally. | Drug: Glucagon Nasal Powder [Baqsimi]<br>* Administered intranasally<br>* Other names: Baqsimi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 summary of SAEs, TEAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Day 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics (PD): Change From Baseline (Predose Blood Glucose) in Maximum Observed Blood Glucose (BGmax) of Nasal Glucagon | PD: Change From Baseline (Predose Blood Glucose) in BGmax of Nasal Glucagon | Predose through Day 1 | 
| PD: Absolute BGmax of Nasal Glucagon | PD: Absolute BGmax of Nasal Glucagon | Predose through Day 1 | 
| PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon | PD: TBGmax of Nasal Glucagon | Predose through Day 1 | 
| PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose | PD: AUC of Blood Glucose | Predose through Day 1 | 
| Pharmacokinetics (PK): AUC of Nasal Glucagon | PK: AUC of Nasal Glucagon | Predose through Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Hypoglycemia, Nasal Powder, Hypoglycemia Rescue Therapy, Ready to use Glucagon