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

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus

Treatments: Drug: Glucagon Nasal Powder; Drug: Glucagon Hydrochloride Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03421379

I8R-JE-IGBJ (Other Identifier)

16962

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Glucagon Nasal Powder

Experimental group

Description:

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

Treatment:

Drug: Glucagon Nasal Powder

Glucagon Hydrochloride Solution

Active Comparator group

Description:

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

Treatment:

Drug: Glucagon Hydrochloride Solution