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Completed

NCT Number: NCT04992312

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nemours Childrens Clinic, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucagon Nasal Powder [Baqsimi]

Drug

Administered intranasally

Other names: LY900018, Baqsimi

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

    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.

  2. PD: Absolute BGmax of Nasal Glucagon

    Time frame: Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)

    PD: Absolute BGmax of Nasal Glucagon

  3. 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: TBGmax of Nasal Glucagon

  4. 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)

    AUC from time 0 to the last measured concentration of blood glucose at 90 minutes [AUC(0-90)] is reported.

  5. Pharmacokinetics (PK): AUC of Nasal Glucagon

    Time frame: Day 1 (10, 30, 60 minutes post-dose)

    PK: AUC of Nasal Glucagon

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Acronym: RescuiNGkids

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 5, 2021
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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