| Trial ID: | L2375 |
| Source ID: | NCT02171130
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| Associated Drug: |
Nasal Glucagon
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| Title: |
Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT02171130/results
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| Conditions: |
Hypoglycemia|Diabetes Mellitus|Drug-Specific Antibodies
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| Interventions: |
DRUG: Nasal Glucagon
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| Outcome Measures: |
Primary: 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., Within 30 minutes after each drug administration for an episode of hypoglycemia | Secondary: 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)., After each drug administration for an episode of hypoglycemia|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., Within 2 hours of full recovery from a hypoglycemic event | Other: Blood Glucose Levels Over Time, 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., Baseline (just prior to dosing or right after study drug administration) , 15, 30 and 45 minutes after drug administration for an episode of hypoglycemia|Number of Participants With Treatment-Emergent Glucagon Anti-Drug Antibodies (ADA), 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., Baseline and End of Study (6 months)
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| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company | Collaborators: Locemia Solutions ULC
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
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| Enrollment: |
129
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2014-05
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| Completion Date: |
2015-08
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| Results First Posted: |
2019-10-15
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| Last Update Posted: |
2019-10-15
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| Locations: |
New England Diabetes and Endocrinology Center (NEDEC), Waltham, Massachusetts, 02451-1136, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|Albany Medical College Division of Community Endocrinology, Albany, New York, 12206, United States|Winnipeg Clinic, Winnipeg, Manitoba, R3C 0N2, Canada|Diabetes Clinic, Smiths Falls, Ontario, K7A 4W8, Canada|IRCM, Montreal, Quebec, H2W 1R7, Canada|Centre de recherche d'endocrinologie Godin & St-Pierre, Sherbrooke, Quebec, J1G 5K2, Canada|Applied Medical Informatics Research, Westmount, Quebec, H3Z 1E5, Canada|Centre Hospitalier de l'Université de Québec, Quebec, G1V 4G2, Canada
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| URL: |
https://clinicaltrials.gov/show/NCT02171130
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