A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes
NCT ID: NCT04992312
Last Updated: 2024-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
7 participants
INTERVENTIONAL
2022-03-24
2023-11-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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3 milligram (mg) Nasal Glucagon
Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1.
Glucagon Nasal Powder [Baqsimi]
Administered intranasally
Interventions
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Glucagon Nasal Powder [Baqsimi]
Administered intranasally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
1 Year
4 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes (RescuiNGkids)
Other Identifiers
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I8R-MC-IGBO
Identifier Type: OTHER
Identifier Source: secondary_id
2021-006088-61
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17449
Identifier Type: -
Identifier Source: org_study_id
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