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

Lilly

Status and phase: Completed; Phase 1

Conditions: Hypoglycemia; Diabetes Mellitus, Type 1

Treatments: Drug: Intramuscular Glucagon; Drug: Nasal Glucagon

Study type: Interventional

Funder types: Industry

Identifiers

NCT03339453

I8R-MC-IGBI (Other Identifier)

16547

2017-000249-33 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 70 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Nasal Glucagon

Experimental group

Description:

Single dose of Nasal Glucagon.

Treatment:

Drug: Nasal Glucagon

Intramuscular Glucagon

Active Comparator group

Description:

Single intramuscular (IM) dose of Glucagon.

Treatment:

Drug: Intramuscular Glucagon