Trial · Interventional

CompletedPhase 3Results postedRegistry data

Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia

NCTNCT02171130Other id16427Other idI8R-MC-B002Other idAMG108

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Overview

Status: Completed
Phase: Phase 3
Enrollment: 129 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 2 countries
United States, Canada
Start: May 2014
Primary completion: Aug 2015
Completion: Aug 2015
First posted: 24 Jun 2014 (estimated)
Last update posted: 15 Oct 2019
Conditions: Hypoglycemia · Diabetes Mellitus · Drug-Specific Antibodies

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201420152016

Ph 3
Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia
NCT02171130
May 2014 to Aug 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Nasal GlucagonDrug

Arms1

Experimental
Nasal glucagon
3 mg nasal glucagon powder delivered using a nasal powder dosing device.

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
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(2)

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
Registry description
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).
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
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Within 30 minutes after each drug administration for an episode of hypoglycemia

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

Group	Value (percentage of participants)
Nasal Glucagon	95.7

Secondary and other outcome results(4)

Secondary outcomeCount of units· After each drug administration for an episode of hypoglycemia

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

Group	Value (Total Number of Events)
Nasal Glucagon	2

Secondary outcomeNumber· Within 2 hours of full recovery from a hypoglycemic event

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

Group	Value (percentage of participants)
Nasal Glucagon	82.8

Other pre specified outcomeMean· Baseline (just prior to dosing or right after study drug administration) , 15, 30 and 45 minutes after drug administration for an episode of hypoglycemia

Blood Glucose Levels Over Time

Group	Value (milligram/deciliter (mg/dL))	Spread
Nasal Glucagon	47.9	10.47

Other pre specified outcomeNumber· Baseline and End of Study (6 months)

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

Group	Value (percentage of participants)
Nasal Glucagon	0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Nasal GlucagonNasal Glucagon powder (3mg)	1 / 87	1 / 87	74 / 87

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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