Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia

Eli Lilly and Company129 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

129

Conditions

Hypoglycemia Diabetes Mellitus Drug-Specific Antibodies

Interventions

Nasal GlucagonDRUG

3 mg nasal glucagon powder

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (9)

New England Diabetes and Endocrinology Center (NEDEC)

Waltham, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Albany Medical College Division of Community Endocrinology

Albany, New York, United States

Outcomes

Primary Outcomes

Percentage of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration

Responses to questions completed by the caregiver were used to assess this outcome. An episode of severe hypoglycemia was defined as an episode wherein the person with diabetes is clinically incapacitated to the point where the person requires third-party assistance to treat the hypoglycemia. An episode of moderate hypoglycemia episode was defined as an episode wherein the person with diabetes was showing signs of neuroglycopenia and had a glucometer reading of approximately 60 milligrams per deciliter (mg/dL) (3.3 millimoles per liter \[mmol/L\]) or less based on a blood sample taken at or near the time of treatment.

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

Secondary Outcomes

Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver

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, Nasal Glucagon is easy to carry and would be willing to carry it, nasal 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

Percentage of Participants With Adverse Events (AEs) Reported Through the Nasal Score Questionnaire

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 nonserious AEs, and all Serious Adverse Events (SAEs), regardless of causality, is located in the Reported Adverse Events section.

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

Data from ClinicalTrials.gov

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