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Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02171130
Recruitment Status : Completed
First Posted : June 24, 2014
Results First Posted : October 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
Locemia Solutions ULC
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Hypoglycemia Diabetes Mellitus Drug-Specific Antibodies Drug: Nasal Glucagon Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Glucagon

Arm Intervention/treatment
Experimental: Nasal glucagon
3 mg nasal glucagon powder delivered using a nasal powder dosing device.
Drug: Nasal Glucagon
3 mg nasal glucagon powder
Other Names:
  • Dry-Mist Nasal Glucagon
  • AMG504-1
  • LY900018




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02171130


Locations
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United States, Massachusetts
New England Diabetes and Endocrinology Center (NEDEC)
Waltham, Massachusetts, United States, 02451-1136
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Albany Medical College Division of Community Endocrinology
Albany, New York, United States, 12206
Canada, Manitoba
Winnipeg Clinic
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, Ontario
Diabetes Clinic
Smiths Falls, Ontario, Canada, K7A 4W8
Canada, Quebec
IRCM
Montreal, Quebec, Canada, H2W 1R7
Centre de recherche d'endocrinologie Godin & St-Pierre
Sherbrooke, Quebec, Canada, J1G 5K2
Applied Medical Informatics Research
Westmount, Quebec, Canada, H3Z 1E5
Canada
Centre Hospitalier de l'Université de Québec
Quebec, Canada, G1V 4G2
Sponsors and Collaborators
Eli Lilly and Company
Locemia Solutions ULC
Investigators
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Study Director: 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) Eli Lilly and Company
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02171130    
Other Study ID Numbers: 16427
I8R-MC-B002 ( Other Identifier: Eli Lilly and Company )
AMG108 ( Other Identifier: Locemia Solutions ULC )
First Posted: June 24, 2014    Key Record Dates
Results First Posted: October 15, 2019
Last Update Posted: October 15, 2019
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Keywords provided by Eli Lilly and Company:
Diabetes Mellitus
Hypoglycemia
Glucagon
Anti-glucagon Antibody
Immunogenicity
Additional relevant MeSH terms:
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Diabetes Mellitus
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins