Clinical trial NCT02171130: Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia
Official title: A Multiple Center, Open Label, Prospective, Observational Study to Evaluate the Effectiveness and Ease-of-Use of AMG504-1 Administered in the Home or Work Environments for Treating Episodes of Hypoglycemia in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoglycemia
Diabetes Mellitus
Drug-Specific Antibodies
Keywords: Diabetes Mellitus
Hypoglycemia
Glucagon
Anti-glucagon Antibody
Immunogenicity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Locemia Solutions ULC
First posted: 2014-06-24
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration
timeFrame: Within 30 minutes after each drug administration for an episode of hypoglycemia
Secondary outcomes:
measure: Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver
timeFrame: After each drug administration for an episode of hypoglycemia
measure: Percentage of Participants With Adverse Events (AEs) Reported Through the Nasal Score Questionnaire
timeFrame: Within 2 hours of full recovery from a hypoglycemic event
Other outcomes:
measure: Blood Glucose Levels Over Time
timeFrame: Baseline (just prior to dosing or right after study drug administration) , 15, 30 and 45 minutes after drug administration for an episode of hypoglycemia
measure: Number of Participants With Treatment-Emergent Glucagon Anti-Drug Antibodies (ADA)
timeFrame: Baseline and End of Study (6 months)
Locations:
city: Waltham
country: United States
facility: New England Diabetes and Endocrinology Center (NEDEC)
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Albany
country: United States
facility: Albany Medical College Division of Community Endocrinology
state: New York
city: Winnipeg
country: Canada
facility: Winnipeg Clinic
state: Manitoba
city: Smiths Falls
country: Canada
facility: Diabetes Clinic
state: Ontario
city: Montreal
country: Canada
facility: IRCM
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre de recherche d'endocrinologie Godin & St-Pierre
state: Quebec
city: Westmount
country: Canada
facility: Applied Medical Informatics Research
state: Quebec
city: Quebec
country: Canada
facility: Centre Hospitalier de l'Université de Québec
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: