- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04992312
A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes (RescuiNGkids)
December 29, 2023 updated by: Eli Lilly and Company
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Phone Number: 1-317-615-4559
- Email: ClinicalTrials.gov@lilly.com
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32207
- Nemours Childrens Clinic
-
-
Idaho
-
Boise, Idaho, United States, 83712
- St. Luke's Regional Medical Center
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55454
- University of Minnesota Medical School
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital
-
-
New York
-
Buffalo, New York, United States, 14203
- UBMD Pediatrics
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Childrens Hospital Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 4 years (Child)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Glucagon Nasal Powder
A single dose of glucagon nasal powder administered intranasally.
|
Administered intranasally
Other Names:
|
What is the study measuring?
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
Time Frame: Baseline through Day 9
|
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
Time Frame: Predose through Day 1
|
PD: Change From Baseline (Predose Blood Glucose) in BGmax of Nasal Glucagon
|
Predose through Day 1
|
PD: Absolute BGmax of Nasal Glucagon
Time Frame: Predose through Day 1
|
PD: Absolute BGmax of Nasal Glucagon
|
Predose through Day 1
|
PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon
Time Frame: Predose through Day 1
|
PD: TBGmax of Nasal Glucagon
|
Predose through Day 1
|
PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose
Time Frame: Predose through Day 1
|
PD: AUC of Blood Glucose
|
Predose through Day 1
|
Pharmacokinetics (PK): AUC of Nasal Glucagon
Time Frame: Predose through Day 1
|
PK: AUC of Nasal Glucagon
|
Predose through Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 24, 2022
Primary Completion (Actual)
November 3, 2023
Study Completion (Actual)
November 3, 2023
Study Registration Dates
First Submitted
August 4, 2021
First Submitted That Met QC Criteria
August 4, 2021
First Posted (Actual)
August 5, 2021
Study Record Updates
Last Update Posted (Estimated)
January 1, 2024
Last Update Submitted That Met QC Criteria
December 29, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17449
- I8R-MC-IGBO (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 1 Diabetes
-
Poznan University of Medical SciencesUnknownDiabetes Mellitus Type 1 | Remission of Type 1 Diabetes | Chronic Complications of DiabetesPoland
-
Eledon PharmaceuticalsWithdrawnBrittle Type 1 Diabetes MellitusUnited States
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Hoffmann-La RocheCompletedType 2 Diabetes, Type 1 DiabetesAustria, United Kingdom
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
NYU Langone HealthNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
Rabin Medical CenterDreaMed DiabetesTerminated
Clinical Trials on Glucagon Nasal Powder [Baqsimi]
-
Eli Lilly and CompanyLocemia Solutions ULCCompleted
-
Eli Lilly and CompanyCompletedDiabetes MellitusJapan
-
Eli Lilly and CompanyLocemia Solutions ULCCompletedDiabetes Mellitus | Drug-specific AntibodiesCanada
-
Eli Lilly and CompanyCompletedDiabetes Mellitus | HypoglycemiaUnited States
-
Eli Lilly and CompanyLocemia Solutions ULCCompletedDiabetes Mellitus | Hypoglycemia | Drug-Specific AntibodiesUnited States, Canada
-
Eli Lilly and CompanyCompleted
-
Eli Lilly and CompanyCompletedHypoglycemia | Diabetes Mellitus, Type 1Germany
-
Eli Lilly and CompanyJaeb Center for Health Research; Locemia Solutions ULCCompletedDiabetes Mellitus, Type 1United States
-
Eli Lilly and CompanyLocemia Solutions ULC; T1D Exchange Clinic Network Coordinating CenterCompletedDiabetes Mellitus, Type 1United States
-
Eli Lilly and CompanyLocemia Solutions ULCCompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type 1Canada