A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-21

Study Completion Date

2018-08-20

Brief Summary

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The purpose of this study is to determine the efficacy and safety of nasal glucagon compared to intramuscular (IM) glucagon for treatment of insulin-induced hypoglycemia in Japanese participants with diabetes mellitus.

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glucagon Nasal Powder

A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally.

Group Type EXPERIMENTAL

Glucagon Nasal Powder

Intervention Type DRUG

Administered intranasally

Glucagon Hydrochloride Solution

A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)

Group Type ACTIVE_COMPARATOR

Glucagon Hydrochloride Solution

Intervention Type DRUG

Administered IM

Interventions

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Glucagon Nasal Powder

Administered intranasally

Intervention Type DRUG

Glucagon Hydrochloride Solution

Administered IM

Intervention Type DRUG

Other Intervention Names

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LY900018 GlucaGen®

Eligibility Criteria

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Inclusion Criteria

* Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)
* Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or 18.5 to 35.0 kg/m2 for T2D
* Hemoglobin A1c (HbA1c) ≤10%

Exclusion Criteria

* Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month
* Have received a total daily dose of insulin \>1.2 units per kilogram (U/kg)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No