Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-02-25 @ 8:25 PM
Study NCT ID:
NCT02402933
Status:
COMPLETED
Last Update Posted:
2019-09-23
First Post:
2015-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Usability of Nasal Glucagon in Treatment of Hypoglycemia in Children and Adolescents
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
A Multiple Center, Open Label, Prospective Study to Evaluate the Effectiveness and Ease-Of-Use of AMG504-1 Administered in the Home or School Environments for Treating Hypoglycemia in Children and Adolescents With T1D
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Up to fifty (50) children and adolescents with type 1 diabetes (T1D) aged 4 to ˂18 years at time of enrolment will be selected for inclusion in the study. The target is to obtain treatment response and user-experience data following use of Nasal Glucagon (LY900018) in treating episodes of hypoglycemia.
Detailed Description:
This study is designed to evaluate the effectiveness of nasal glucagon (NG) administered under clinical use conditions in treating episodes of moderate or severe hypoglycemia in persons with T1D.
This study also aims to assess the ease with which caregivers can administer the experimental medication in treatment of hypoglycemic events.
This study also aims to assess the ease with which caregivers can administer the experimental medication in treatment of hypoglycemic events.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: