Clinical Usability of Nasal Glucagon in Treatment of Hypoglycemia in Children and Adolescents

Responses to questions completed by the caregiver are used to assess this outcome. An episode of severe hypoglycemia is generally defined as an event associated with severe neuroglycopenia usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose) administered by a third party. In this study moderate hypoglycemia is defined as an episode wherein the child/adolescent with diabetes has symptoms and/or signs of neuroglycopenia and has a blood glucose ≤3.9 millimoles per liter (mmol/L) (70 milligram per deciliter \[mg/dL\]) based on a blood sample taken at or close to the time of treatment.

Time frame: Within 30 minutes after each drug administration for an episode of hypoglycemia

Population: Participants who received at least 1 dose of NG with evaluable treatment response. Events for which participants required external professional medical assistance or used injected glucagon or oral carbohydrates within 30 minutes and before responding were non-evaluable. The good clinical practice (GCP) non-compliant site were also excluded.

Assess ease-of-use of intranasal administered glucagon in the hands of caregivers of participants who may be called upon to treat episodes of hypoglycemia. Measurement for Degree of difficulty: opening the kit, Degree of difficulty: understanding the instructions on how to use the kit, Degree of difficulty: administering the medication into the nostril, Degree of satisfaction is 1 (Very Difficult) to 7 (Very Easy). Measurement for Dry Mist Nasal Glucagon will be easy to teach other caregivers, Nasal formulation of glucagon is less intimidating for caregivers, Dry Mist Nasal Glucagon is easy to carry and would be willing to carry it, Intranasal delivery of glucagon is preferable: level of agreement 1 (Strongly Disagree) to 7 (Strongly Agree).

Time frame: After each drug administration for an episode of hypoglycemia

Population: Participants who received at least 1 dose of NG and experienced at least 1 hypoglycemic event. Participants from the GCP non-compliant site were excluded. Proportions and n are based on the total number of hypoglycemic events (N=33) of 14 participants; except Compare to Injectable is based on 8 events.

Adverse events solicited through the Nasal Score Questionnaire included: runny nose, nasal congestion (nostrils plugged), nasal itching, sneezing, watery eyes, itchy eyes, redness of eyes, itching of ears, itching of throat, and other. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Time frame: Within 2 hours of full recovery from a hypoglycemic event

Population: Participants who received at least 1 dose of NG and experienced at least 1 hypoglycemic event.Participants from the GCP non-compliant site were considered ineligible and thus excluded from this population.

Glucometer-based measurements of blood glucose after the studied drug administration. The participants' change in blood glucose level from baseline (just prior to dosing or right after the study drug administration) was measured by the caregiver using a glucometer at 15, 30 and 45 minutes after NG administration. The change in glucose was calculated from each time point (15, 30 and 45 minutes) minus the baseline.

Time frame: Baseline (just prior to dosing or right after study drug administration), 15, 30 and 45 minutes after drug administration for an episode of hypoglycemia

Population: Participants received at least 1 dose of the NG and experienced at least 1 hypoglycemic event. Participants from the GCP non-compliant site were considered ineligible and thus excluded from this population.