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

Eli Lilly and Company7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Eligibility

Sex: ALLMin age: 1 YearMax age: 4 Years

Medical Language ↔ Plain English

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

Locations (8)

Nemours Childrens Clinic

Jacksonville, Florida, United States

St. Luke's Regional Medical Center

Boise, Idaho, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

University of Minnesota Medical School

Minneapolis, Minnesota, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

UBMD Pediatrics

Buffalo, New York, United States

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to Day 9

Secondary Outcomes

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.

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

PD: 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

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

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

Pharmacokinetics (PK): AUC of Nasal Glucagon

PK: AUC of Nasal Glucagon

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