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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-10

Study Completion Date

2018-01-13

Brief Summary

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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).

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Detailed Description

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Conditions

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Hypoglycemia Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Nasal Glucagon

Single dose of Nasal Glucagon.

Group Type EXPERIMENTAL

Nasal Glucagon

Intervention Type DRUG

Administered nasally

Intramuscular Glucagon

Single intramuscular (IM) dose of Glucagon.

Group Type ACTIVE_COMPARATOR

Intramuscular Glucagon

Intervention Type DRUG

Administered IM

Interventions

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Nasal Glucagon

Administered nasally

Intervention Type DRUG

Intramuscular Glucagon

Administered IM

Intervention Type DRUG

Other Intervention Names

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LY900018 GlucaGen®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No