Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia

Condition(s) targeted: Hypoglycemia; Diabetes Mellitus; Drug-Specific Antibodies

Intervention: 3 mg glucagon powder (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Locemia Solutions ULC

Official(s) and/or principal investigator(s):
Elizabeth Seaquist, MD, Principal Investigator, Affiliation: University of Minnesota - Clinical and Translational Science Institute

Up to two hundred (200) adult patients with 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 AMG504-1 in treating episodes of hypoglycemia. The population will be enriched to include participants who suffer from impaired hypoglycemia awareness.

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of Patients Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug Administration

Secondary outcome:

Assessment of Ease-of-use of Dry-Mist Nasal Glucagon by Completion of Questionnaires by the Caregiver

To evaluate local tolerability from the patient's perspective

Detailed description: This study proposes to evaluate the effectiveness of intranasal (IN) glucagon 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 patients' assessment of local tolerability and provide information on immunogenicity of AMG504-1 with regards to the potential development of anti-glucagon antibodies.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Centre Hospitalier de l'Université de Québec, Quebec G1V 4G2, Canada

Winnipeg Clinic, Winnipeg, Manitoba R3C 0N2, Canada

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

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

Starting date: May 2014
Last updated: August 10, 2015