Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia

Status Completed

Clinical Trial Summary

Up to two hundred (200) adult participants with type 1 diabetes (T1D) aged 18 to 75 years will be selected for inclusion in the study. The target is to obtain treatment response and user-experience data following use of nasal glucagon (AMG504-1) in treating episodes of hypoglycemia. The population will be enriched to include participants who suffer from impaired hypoglycemia awareness.

Clinical Trial Description

This study is designed to evaluate the effectiveness of nasal glucagon (NG) administered under clinical use conditions in treating episodes of 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.

The study will also generate data on the participants' assessment of local tolerability and provide information on immunogenicity of nasal glucagon with regards to the potential development of anti-glucagon antibodies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02171130
Study type	Interventional
Source	Eli Lilly and Company
Contact
Status	Completed
Phase	Phase 3
Start date	May 2014
Completion date	August 2015

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