Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia
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
3 other identifiers
interventional
129
2 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2014
Shorter than P25 for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 12, 2014
CompletedFirst Posted
Study publicly available on registry
June 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
October 15, 2019
CompletedOctober 15, 2019
March 1, 2017
1.3 years
June 12, 2014
August 14, 2019
September 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver
After each drug administration for an episode of hypoglycemia
Percentage of Participants With Adverse Events (AEs) Reported Through the Nasal Score Questionnaire
Within 2 hours of full recovery from a hypoglycemic event
Other Outcomes (2)
Blood Glucose Levels Over Time
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)
Baseline and End of Study (6 months)
Study Arms (1)
Nasal glucagon
EXPERIMENTAL3 mg nasal glucagon powder delivered using a nasal powder dosing device.
Interventions
3 mg nasal glucagon powder
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
- Use of a daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Locemia Solutions ULCcollaborator
Study Sites (9)
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 Hospitalier de l'Université de Québec
Québec, Quebec, G1V 4G2, Canada
Centre de recherche d'endocrinologie Godin & St-Pierre
Sherbrooke, Quebec, J1G 5K2, Canada
Applied Medical Informatics Research
Westmount, Quebec, H3Z 1E5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Sixteen participants were discontinued early because of a clinical trial material issue which might have led to under-dose. One site was terminated due to GCP non-compliance and five participants were discontinued as a result.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2014
First Posted
June 24, 2014
Study Start
May 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
October 15, 2019
Results First Posted
October 15, 2019
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.