Trial · NCT03421379

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

NCT03421379, Phase 3, Completed, Eli Lilly and Company; results first posted 2019-10-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus. Trials, record NCT03421379. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03421379

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus
NCT number: NCT03421379
Status: Completed
Phases: Phase 3
Enrollment: 75 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Diabetes Mellitus
Interventions: Glucagon Nasal Powder, Glucagon Hydrochloride Solution
First posted: 2018-02-05
Last updated: 2019-10-08
Results first posted: 2019-10-08

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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).
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia	Pre-dose up to 30 minutes post each glucagon administration	All randomized participant who completed both treatment visits and had evaluable treatment success data.	percentage of participants	NUMBER
SECONDARY	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	All randomized patients who receive at least 1 dose of the study drug and have evaluable PD data.	milligram/deciliter (mg/dL)	GEOMETRIC_MEAN
SECONDARY	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	All randomized participants who received at least one dose of study drug and had evaluable PD data.	hour	MEDIAN
SECONDARY	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	All randomized participants who received at least one dose of study drug and had evaluable PK data.	Picogramhour/milliliter (pgh/mL)	GEOMETRIC_MEAN
SECONDARY	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	All randomized participants who received at least one dose of study drug and had evaluable PK data.	picogram/milliliter (pg/mL)	GEOMETRIC_MEAN
SECONDARY	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	All randomized participants who received at least one dose of study drug and had evaluable PK data.	hour (h)	MEDIAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia	Glucagon Nasal Powder	100		percentage of participants
Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia	Glucagon Hydrochloride Solution	100		percentage of participants
Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)	Glucagon Nasal Powder	113	Geometric Coefficient of Variation 32	milligram/deciliter (mg/dL)
Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)	Glucagon Hydrochloride Solution	119	Geometric Coefficient of Variation 33	milligram/deciliter (mg/dL)
PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM	Glucagon Nasal Powder	1.00	Full Range 0.50 to 4.02	hour
PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM	Glucagon Hydrochloride Solution	1.50	Full Range 0.67 to 4.00	hour
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	Glucagon Nasal Powder	4830	Geometric Coefficient of Variation 89	Picogramhour/milliliter (pgh/mL)
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	Glucagon Hydrochloride Solution	3240	Geometric Coefficient of Variation 32	Picogramhour/milliliter (pgh/mL)
PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM	Glucagon Nasal Powder	9520	Geometric Coefficient of Variation 103	picogram/milliliter (pg/mL)
PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM	Glucagon Hydrochloride Solution	3290	Geometric Coefficient of Variation 37	picogram/milliliter (pg/mL)

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1	STARTED	Glucagon Nasal Powder/Glucagon Hydrochloride	34
Period 1	STARTED	Glucagon Hydrochloride Solution/Glucagon Nasal Powder	41
Period 1	Received at Least One Dose of Study Drug	Glucagon Nasal Powder/Glucagon Hydrochloride	33
Period 1	Received at Least One Dose of Study Drug	Glucagon Hydrochloride Solution/Glucagon Nasal Powder	39
Period 1	COMPLETED	Glucagon Nasal Powder/Glucagon Hydrochloride	32
Period 1	COMPLETED	Glucagon Hydrochloride Solution/Glucagon Nasal Powder	37
Period 1	NOT COMPLETED	Glucagon Nasal Powder/Glucagon Hydrochloride	2
Period 1	NOT COMPLETED	Glucagon Hydrochloride Solution/Glucagon Nasal Powder	4
Washout Period (3 to 14 Days)	STARTED	Glucagon Nasal Powder/Glucagon Hydrochloride	32
Washout Period (3 to 14 Days)	STARTED	Glucagon Hydrochloride Solution/Glucagon Nasal Powder	37

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events46

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Ear pain	Ear and labyrinth disorders	Glucagon Nasal Powder	2	71	2
other	Ear pain	Ear and labyrinth disorders	Glucagon Hydrochloride Solution	0	70	0
other	Eye pain	Eye disorders	Glucagon Nasal Powder	1	71	1
other	Eye pain	Eye disorders	Glucagon Hydrochloride Solution	0	70	0
other	Eye pruritus	Eye disorders	Glucagon Nasal Powder	1	71	1
other	Eye pruritus	Eye disorders	Glucagon Hydrochloride Solution	0	70	0
other	Lacrimation increased	Eye disorders	Glucagon Nasal Powder	1	71	1
other	Lacrimation increased	Eye disorders	Glucagon Hydrochloride Solution	0	70	0
other	Diarrhoea	Gastrointestinal disorders	Glucagon Nasal Powder	1	71	1
other	Diarrhoea	Gastrointestinal disorders	Glucagon Hydrochloride Solution	0	70	0

1 to 10 of 46Source ClinicalTrials.gov

See all 46 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Glucagon Nasal Powder	0	71
Total, all-cause mortality	Glucagon Hydrochloride Solution	0	70
Total, other adverse events	Glucagon Nasal Powder	15	71
Total, other adverse events	Glucagon Hydrochloride Solution	13	70
Total, serious adverse events	Glucagon Nasal Powder	0	71
Total, serious adverse events	Glucagon Hydrochloride Solution	1	70

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38444629	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Glucagon Nasal Powder vs Glucagon Hydrochloride Solution: deaths from any cause	Trial comparisons
Glucagon Nasal Powder vs Glucagon Hydrochloride Solution: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03421379

GET https://conductscience.org/api/trials/v1/NCT03421379/events?page=2

API reference For AI assistants