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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT03421379 (opens ClinicalTrials.gov in a new tab)Other id16962Other idI8R-JE-IGBJ
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
75 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Japan

Start
21 Feb 2018
Primary completion
20 Aug 2018
Completion
20 Aug 2018
First posted
5 Feb 2018
Last update posted
8 Oct 2019
Conditions
Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20182019
  1. Ph 3

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

    NCT03421379

    21 Feb 2018 to 20 Aug 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Glucagon Nasal PowderDrug
  • Glucagon Hydrochloride SolutionDrug

Arms2

  • Experimental

    Glucagon Nasal Powder

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

  • Active comparator

    Glucagon Hydrochloride Solution

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia

    Time frame · Pre-dose up to 30 minutes post each glucagon administration

    Registry description

    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 outcomes(5)

  1. Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)

    Time frame · Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration

    Registry description

    PD assessment measured the change from Baseline in maximal blood glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride intramuscular (IM).

  2. PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM

    Time frame · Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration

    Registry description

    PD assessment measured the time to maximal concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM.

  3. 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

    Time frame · Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration

    Registry description

    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.

  4. PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM

    Time frame · Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration

    Registry description

    PK assessment measured the change from baseline in maximal concentration (Cmax) of glucagon nasal powder and glucagon hydrochloride IM.

  5. PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM

    Time frame · Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration

    Registry description

    PK assessment measured the change from baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Pre-dose up to 30 minutes post each glucagon administration

Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia

GroupValue (percentage of participants)
Glucagon Nasal Powder100
Glucagon Hydrochloride Solution100
Secondary and other outcome results(5)
Secondary outcomeGeometric mean· Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration

Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)

GroupValue (milligram/deciliter (mg/dL))Spread
Glucagon Nasal Powder11332
Glucagon Hydrochloride Solution11933
Secondary outcomeMedian· Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration

PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM

GroupValue (hour)
Glucagon Nasal Powder1.00
Glucagon Hydrochloride Solution1.50
Secondary outcomeGeometric mean· Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration

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

GroupValue (Picogram*hour/milliliter (pg*h/mL))Spread
Glucagon Nasal Powder483089
Glucagon Hydrochloride Solution324032
Secondary outcomeGeometric mean· Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration

PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM

GroupValue (picogram/milliliter (pg/mL))Spread
Glucagon Nasal Powder9520103
Glucagon Hydrochloride Solution329037
Secondary outcomeMedian· Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration

PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM

GroupValue (hour (h))
Glucagon Nasal Powder0.25
Glucagon Hydrochloride Solution0.17

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Glucagon Nasal PowderA single dose of 3 mg glucagon nasal powder was administered intranasally0 / 710 / 7115 / 71
Glucagon Hydrochloride SolutionA single dose of 1 mg glucagon hydrochloride solution was administered IM0 / 701 / 7013 / 70

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2024

10 results

Nasal Glucagon Reverses Insulin-induced Hypoglycemia With Less Rebound Hyperglycemia: Pooled Analysis of Clinical Trials.

Seaquist et al. 2024Journal of the Endocrine Societycited by 2

PMID 38444629PMC10913376DOI 10.1210/jendso/bvae034PUB-38444629

Free to read · publisher termsCC BY-NC-ND10 results
Read at sourceSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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