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

Sponsors

Lead Sponsor: Eli Lilly and Company

Collaborator: Locemia Solutions ULC

Source Eli Lilly and Company
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.

Detailed 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.

Overall Status Completed
Start Date May 2014
Completion Date August 2015
Primary Completion Date August 2015
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration Within 30 minutes after each drug administration for an episode of hypoglycemia
Secondary Outcome
Measure Time Frame
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
Enrollment 129
Condition
Intervention

Intervention Type: Drug

Intervention Name: Nasal Glucagon

Description: 3 mg nasal glucagon powder

Arm Group Label: Nasal glucagon

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
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) Study Director Eli Lilly and Company
Location
Facility:
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
Location Countries

Canada

United States

Verification Date

March 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Nasal glucagon

Type: Experimental

Description: 3 mg nasal glucagon powder delivered using a nasal powder dosing device.

Patient Data Yes
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov