Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia

Lilly

Status and phase

Completed

Phase 3

Conditions

Hypoglycemia

Drug-Specific Antibodies

Diabetes Mellitus

Treatments

Drug: Nasal Glucagon

Study type

Interventional

Funder types

Industry

Identifiers

NCT02171130

I8R-MC-B002 (Other Identifier)

AMG108 (Other Identifier)

16427

Details and patient eligibility

About

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.

Full 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.

Enrollment

129 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or Female Person with diabetes (PWD) lives with or is in frequent contact with one or more caregivers who are available to administer the glucagon in case of an episode of severe or moderate hypoglycemia
With a history of type 1 diabetes >1 year
At least 18 years of age but not older than 75 years
Body mass index (BMI) greater than or equal to 18.50 and below 35.00 kg/m2.
PWD will be otherwise healthy according to medical history, general physical examination (including vital signs), nasal examination, and laboratory tests (biochemistry, hematology, and urinalysis).
For female subjects, a urine pregnancy test must be negative.

Exclusion criteria

Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
Use of a daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.