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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02171130
Other study ID # 16427
Secondary ID I8R-MC-B002AMG10
Status Completed
Phase Phase 3
First received
Last updated
Start date May 2014
Est. completion date August 2015

Study information

Verified date March 2017
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 129
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nasal Glucagon
3 mg nasal glucagon powder

Locations

Country Name City State
Canada IRCM Montreal Quebec
Canada Centre Hospitalier de l'Université de Québec Quebec
Canada Centre de recherche d'endocrinologie Godin & St-Pierre Sherbrooke Quebec
Canada Diabetes Clinic Smiths Falls Ontario
Canada Applied Medical Informatics Research Westmount Quebec
Canada Winnipeg Clinic Winnipeg Manitoba
United States Albany Medical College Division of Community Endocrinology Albany New York
United States University of Minnesota Minneapolis Minnesota
United States New England Diabetes and Endocrinology Center (NEDEC) Waltham Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Eli Lilly and Company Locemia Solutions ULC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
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
Other 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)
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
Secondary 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
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