A Study of Nasal Glucagon in Participants With Type 1 Diabetes Mellitus

• Status: Completed
• Trial end date: 2018-01-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare a needle-free treatment of hypoglycemia with nasal glucagon (study drug) to a marketed glucagon administered by the intramuscular (IM) route, in participants with type 1 diabetes mellitus (T1DM).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Glucagon; Glucagon-Like Peptide 1; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 2 years and receiving daily insulin since the time of diagnosis

Exclusion Criteria:

• Have a history of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs

• Have a history of pheochromocytoma (that is, adrenal gland tumor) or insulinoma

• Occurrence of an episode of severe hypoglycemia (defined as requiring the assistance of another person in the 1 month prior to enrolling in the study)

• Have a history of epilepsy or seizure disorder

• Are women who are pregnant or lactating

• Have, except for the current regimen of insulin therapy and concomitant medication, regular use of or intended use of any over-the-counter or prescription medications or nutritional supplements that treat hyperglycemia or insulin resistance or that promote weight loss within 14 days before dosing

• Daily use of systemic beta-blocker, indomethacin, warfarin or anticholinergic drugs

• Require daily insulin treatment greater than (>)1.5 unit/kilograms (U/kg)/body weight