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Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia

Primary Purpose

Hypoglycemia, Diabetes Mellitus, Drug-Specific Antibodies

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nasal Glucagon
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoglycemia focused on measuring Diabetes Mellitus, Hypoglycemia, Glucagon, Anti-glucagon Antibody, Immunogenicity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New England Diabetes and Endocrinology Center (NEDEC)
  • University of Minnesota
  • Albany Medical College Division of Community Endocrinology
  • Winnipeg Clinic
  • Diabetes Clinic
  • IRCM
  • Centre de recherche d'endocrinologie Godin & St-Pierre
  • Applied Medical Informatics Research
  • Centre Hospitalier de l'Université de Québec

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nasal glucagon

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
June 12, 2014
Last Updated
September 27, 2019
Sponsor
Eli Lilly and Company
Collaborators
Locemia Solutions ULC
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1. Study Identification

Unique Protocol Identification Number
NCT02171130
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
Locemia Solutions ULC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia, Diabetes Mellitus, Drug-Specific Antibodies
Keywords
Diabetes Mellitus, Hypoglycemia, Glucagon, Anti-glucagon Antibody, Immunogenicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasal glucagon
Arm Type
Experimental
Arm Description
3 mg nasal glucagon powder delivered using a nasal powder dosing device.
Intervention Type
Drug
Intervention Name(s)
Nasal Glucagon
Other Intervention Name(s)
Dry-Mist Nasal Glucagon, AMG504-1, LY900018
Intervention Description
3 mg nasal glucagon powder
Primary Outcome Measure Information:
Title
Percentage of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration
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.
Time Frame
Within 30 minutes after each drug administration for an episode of hypoglycemia
Secondary Outcome Measure Information:
Title
Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver
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).
Time Frame
After each drug administration for an episode of hypoglycemia
Title
Percentage of Participants With Adverse Events (AEs) Reported Through the Nasal Score Questionnaire
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.
Time Frame
Within 2 hours of full recovery from a hypoglycemic event
Other Pre-specified Outcome Measures:
Title
Blood Glucose Levels Over Time
Description
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.
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
Title
Number of Participants With Treatment-Emergent Glucagon Anti-Drug Antibodies (ADA)
Description
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.
Time Frame
Baseline and End of Study (6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
New England Diabetes and Endocrinology Center (NEDEC)
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451-1136
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Albany Medical College Division of Community Endocrinology
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Winnipeg Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
Diabetes Clinic
City
Smiths Falls
State/Province
Ontario
ZIP/Postal Code
K7A 4W8
Country
Canada
Facility Name
IRCM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada
Facility Name
Centre de recherche d'endocrinologie Godin & St-Pierre
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 5K2
Country
Canada
Facility Name
Applied Medical Informatics Research
City
Westmount
State/Province
Quebec
ZIP/Postal Code
H3Z 1E5
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Québec
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/

Learn more about this trial

Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia

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