A Study of Nasal Glucagon in Children with Insulin Dependent Diabetes

Phase 1

• Conditions: severe hypoglycemia; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2021-006088-61-Outside-EU/EEA
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-05
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

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 
Are the trial subjects under 18? yes
Number of subjects for this age range: 6
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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 

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and tolerability of a single dose of NG 3 mg in children aged 1 to <4 years with T1D ;Secondary Objective: To assess the PD of a single dose of NG 3 mg in children aged 1 to <4 years with T1D; To assess the PK of a single dose of NG 3 mg in children aged 1 to <4 years with T1D ;Primary end point(s): 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 through Day 9 ] <br><br>A summary of SAEs, TEAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module ;Timepoint(s) of evaluation of this end point: [ Time Frame: Baseline through Day 9 ]

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pharmacodynamics (PD): Change From Baseline (Predose Blood Glucose) in Maximum Observed Blood Glucose (BGmax) of Nasal Glucagon [Time Frame: Predose through Day 1 ] <br>PD: Change From Baseline (Predose Blood Glucose) in BGmax of Nasal Glucagon <br><br>PD: Absolute BGmax of Nasal Glucagon [ Time Frame: Predose through Day 1 ] <br>PD: Absolute BGmax of Nasal Glucagon <br><br>PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon [ Time Frame: Predose through Day 1 ] <br>PD: TBGmax of Nasal Glucagon <br><br>PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose [ Time Frame: Predose through Day 1 ] <br>PD: AUC of Blood Glucose <br><br>Pharmacokinetics (PK): AUC of Nasal Glucagon [ Time Frame: Predose through Day 1 ] <br>PK: AUC of Nasal Glucagon ;Timepoint(s) of evaluation of this end point: [Time Frame: Predose through Day 1 ]