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

Phase 3

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Glucagon Hydrochloride Solution; Drug: Glucagon Nasal Powder

• Registration Number: NCT03421379
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-30
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-05
• Study Start: 2018-02-21
• Primary Completion: 2018-08-20
• Study Completion: 2018-08-20
• Results First Submitted: 2019-08-14
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-18
• Last Update Submitted: 2019-09-18
• Results First Posted: 2019-10-08
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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%

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glucagon Hydrochloride Solution	Glucagon Hydrochloride Solution	A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)
Glucagon Nasal Powder	Glucagon Nasal Powder	A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia	Pre-dose up to 30 minutes post each glucagon administration	Percentage of participants who achieved treatment success during the controlled insulin-induced hypoglycemia in participants with type 1 diabetes mellitus (T1DM) and participants with type 2 diabetes mellitus (T2DM).Treatment success is defined as an increase in plasma glucose to greater than or equal to (≥) 70 milligrams per deciliter (mg/dL) or an increase of ≥20 mg/dL from plasma glucose nadir, without receiving additional actions to increase the plasma glucose concentration. Nadir is defined as the minimum plasma glucose concentration at the time of or within 10 minutes following glucagon administration.

Secondary Outcome Measures

Name	Time	Method
PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM	Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration	PK assessment measured the change from baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM.
PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM	Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration	PK assessment measured the change from baseline in maximal concentration (Cmax) of glucagon nasal powder and glucagon hydrochloride IM.
Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)	Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration	PD assessment measured the change from Baseline in maximal blood glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride intramuscular (IM).
PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM	Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration	PD assessment measured the time to maximal concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM.
Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM	Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration	PK assessment measured the change from baseline in the area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of Glucagon Nasal Powder and Glucagon Hydrochloride IM.

Trial Locations

Locations (2)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇯🇵 Tokyo, Japan

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.; 🇯🇵 Tokyo, Japan