Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study of Nasal Glucagon in Participants With Type 1 Diabetes Mellitus

NCTNCT03339453Other id16547Other idI8R-MC-IGBIOther id2017-000249-33Other id2017

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 70 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
Germany
Start: 10 Nov 2017
Primary completion: 17 Dec 2017
Completion: 13 Jan 2018
First posted: 13 Nov 2017
Last update posted: 23 Sept 2019
Conditions: Hypoglycemia · Diabetes Mellitus, Type 1

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201720182019

Ph 1
A Study of Nasal Glucagon in Participants With Type 1 Diabetes Mellitus
NCT03339453
10 Nov 2017 to 13 Jan 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 compare a needle-free treatment of hypoglycemia with nasal glucagon (study drug) to a marketed glucagon administered by the intramuscular (IM) route, in participants with type 1 diabetes mellitus (T1DM).

Interventions

Nasal GlucagonDrug
Intramuscular GlucagonDrug

Arms2

Experimental
Nasal Glucagon
Single dose of Nasal Glucagon.
Active comparator
Intramuscular Glucagon
Single intramuscular (IM) dose of Glucagon.

Primary outcomes1

Outcomes the sponsor listed as primary.

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
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)

Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax)
Time frame · Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Time frame · Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Baseline Adjusted Glucagon
Time frame · Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
Time frame · Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Time frame · Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration

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 outcomeCount of participants· Pre-dose up to 30 minutes post each glucagon administration

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

Group	Value (Participants)
Nasal Glucagon (NG)	66
IM Glucagon	66

Secondary and other outcome results(5)

Secondary outcomeGeometric mean· Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration

Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax)

Group	Value (Milligrams per deciliter (mg/dL))	Spread
Nasal Glucagon (NG)	132	36
IM Glucagon	161	29

Secondary outcomeMedian· Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration

PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose

Group	Value (Hour (hr))
Nasal Glucagon (NG)	1.00
IM Glucagon	1.50

Secondary outcomeGeometric mean· Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Baseline Adjusted Glucagon

Group	Value (picogramhour per millilitre (pghr/mL))	Spread
Nasal Glucagon (NG)	2740	68
IM Glucagon	3320	40

Secondary outcomeGeometric mean· Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration

PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon

Group	Value (picograms per millilitre (pg/mL))	Spread
Nasal Glucagon (NG)	6130	74
IM Glucagon	3750	44

Secondary outcomeMedian· Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration

PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon

Group	Value (Hour (hr))
Nasal Glucagon (NG)	0.25
IM Glucagon	0.25

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Nasal Glucagon (NG)Dose of 3 mg nasal glucagon.	0 / 70	0 / 70	34 / 70
Intramuscular (IM) GlucagonDose of 1 mg intramuscular glucagon.	0 / 69	0 / 69	35 / 69

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

Studies2

Studies that cite this trial.

Studies with results

2 studies 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 source See results (10)

PubMed tag: none · 2020

5 results

Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study.

Suico et al. 2020Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 26

PMID 32514794PMC7324463DOI 10.1007/s13300-020-00845-7PUB-32514794

Free to read · publisher termsCC BY-NC5 results

Read at source See results (5)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 64 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 2 years and receiving daily insulin since the time of diagnosis Exclusion Criteria: * Have a history of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs * Have a history of pheochromocytoma (that is, adrenal gland tumor) or insulinoma * Occurrence of an episode of severe hypoglycemia (defined as requiring the assistance of another person in the 1 month prior to enrolling in the study) * Have a history of epilepsy or seizure disorder * Are women who are pregnant or lactating * Have, except for the current regimen of insulin therapy and concomitant medication, regular use of or intended use of any over-the-counter or prescription medications or nutritional supplements that treat hyperglycemia or insulin resistance or that promote weight loss within 14 days before dosing * Daily use of systemic beta-blocker, indomethacin, warfarin or anticholinergic drugs * Require daily insulin treatment greater than (\>)1.5 unit/kilograms (U/kg)/body weight

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