Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia
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|ClinicalTrials.gov Identifier: NCT02171130|
Recruitment Status : Completed
First Posted : June 24, 2014
Results First Posted : October 15, 2019
Last Update Posted : October 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypoglycemia Diabetes Mellitus Drug-Specific Antibodies||Drug: Nasal Glucagon||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Nasal glucagon
3 mg nasal glucagon powder delivered using a nasal powder dosing device.
Drug: Nasal Glucagon
3 mg nasal glucagon powder
- 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.
- 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).
- 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.
- 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.
- 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.
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
|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|
|Winnipeg, Manitoba, Canada, R3C 0N2|
|Smiths Falls, Ontario, Canada, K7A 4W8|
|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|
|Centre Hospitalier de l'Université de Québec|
|Quebec, Canada, G1V 4G2|
|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|