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Completed

NCT Number: NCT02171130

Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia

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.

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Key information

Conditions

Hypoglycemia Diabetes Mellitus Drug-Specific Antibodies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Winnipeg Clinic, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nasal Glucagon

Drug

3 mg nasal glucagon powder

Other names: Dry-Mist Nasal Glucagon, AMG504-1, LY900018

Primary outcomes

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

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

    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.

Secondary outcomes

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

    Time frame: After each drug administration for an episode 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, 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).

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

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

    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.

Other outcomes

  1. Blood Glucose Levels Over Time

    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

    The participants' blood glucose level was measured by the caregiver using a glucometer at baseline (just prior to dosing and right after the study drug administration), 15, 30 and 45 minutes after nasal glucagon administration.

  2. Number of Participants With Treatment-Emergent Glucagon Anti-Drug Antibodies (ADA)

    Time frame: Baseline and End of Study (6 months)

    Treatment-Emergent ADA includes treatment-induced ADA ('Not Detected' ADA at baseline and at least one post-baseline 'Detected' ADA sample with a corresponding titer of (1:20) and treatment-boosted ADA (with 'Detected' ADA at baseline and at least one post-baseline 'Detected' ADA sample with a corresponding titer that is at least 4-fold higher than the baseline titer.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Locemia Solutions ULC

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 24, 2014
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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