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

NCT04992312 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 17449I8R-MC-IGBO2021-006088-61
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

Severe Hypoglycemia; Nasal Powder; Hypoglycemia Rescue Therapy; Ready to use Glucagon

Outcome Measures

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

  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.

  Baseline to Day 9

Secondary Outcomes (5)

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

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

• PD: Absolute BGmax of Nasal Glucagon

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

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

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

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

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

• Pharmacokinetics (PK): AUC of Nasal Glucagon

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

Study Arms (1)

3 milligram (mg) Nasal Glucagon

EXPERIMENTAL

Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1.

Drug: Glucagon Nasal Powder [Baqsimi]

Interventions

Glucagon Nasal Powder [Baqsimi] DRUG

Administered intranasally

Also known as: LY900018, Baqsimi

3 milligram (mg) Nasal Glucagon

Eligibility Criteria

• Age: 1 Year - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (8)

Nemours Childrens Clinic

Jacksonville, Florida, 32207, United States

Location

St. Luke's Regional Medical Center

Boise, Idaho, 83712, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

University of Minnesota Medical School

Minneapolis, Minnesota, 55454, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

UBMD Pediatrics

Buffalo, New York, 14203, United States

Location

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 5, 2021
• Study Start: March 24, 2022
• Primary Completion: November 5, 2023
• Study Completion: November 5, 2023
• Last Updated: May 23, 2024
• Results First Posted: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)