Conditions: Hypoglycemia Diabetes Mellitus Drug-Specific Antibodies
Keywords: Diabetes Mellitus Hypoglycemia Glucagon Anti-glucagon Antibody Immunogenicity
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 129
Healthy volunteers: no

Brief 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.

Detailed 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.

Arms:
arm 1: 3 mg nasal glucagon powder delivered using a nasal powder dosing device.

Interventions: intervention 1: Nasal Glucagon
Intervention descriptions: intervention 1: 3 mg nasal glucagon powder

Protocol document: