Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02171130
• Other study ID #: 16427
• Secondary ID: I8R-MC-B002AMG10
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Drug-Specific Antibodies
• Hypoglycemia

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