Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia

Completed · Phase 3

Conditions studied: Hypoglycemia, Diabetes Mellitus, Drug-Specific Antibodies

In brief

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.

Key facts

Study ID

NCT02171130

Run by

Eli Lilly and Company

People needed

129

Starts

2014-05-01

Expected to finish

2015-08-01

Last updated by the study team

2019-10-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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