Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes

NCTNCT01997411Other id16418Other idI8R-MC-IGBBOther idINGluc002Other idAMG103

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2/3
Enrollment: 48 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: Nov 2013
Primary completion: Jan 2015
Completion: Jan 2015
First posted: 28 Nov 2013 (estimated)
Last update posted: 29 Aug 2018
Conditions: Diabetes Mellitus, Type 1

Timeline

1 trial · 1 completed · 1 with posted results

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

2013201420152016

Ph 2/3
Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes
NCT01997411
Nov 2013 to Jan 2015

Registry summary

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

The purpose of this study was to assess how glucagon administered nasally, using a nasal dosing delivery device, works in children and adolescents compared with commercially-available glucagon given by injection. In addition, the safety and tolerability of glucagon given nasally was evaluated.

Interventions

Nasal GlucagonDrug
Intramuscular GlucagonDrug

Arms2

Experimental
Nasal Glucagon (NG)
Nasal glucagon (NG) doses of 2.0 mg and 3.0 mg for participants 4 to less than 12 years of age and 3.0 mg for those 12 to less than 17 years of age were administered in a nostril with a prefilled delivery device that delivered a single dose upon activation.
Active comparator
Intramuscular (IM) Glucagon
Participants who weighed at least 25 kilograms (kg)/55 pounds (lbs) were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 lbs, IM glucagon dosed with 0.5 mg

Primary outcomes6

Outcomes the sponsor listed as primary.

Maximum Change From Baseline Concentration (Cmax) of Glucagon
Time frame · Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Time frame · Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon
Time frame · Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Maximum Concentration (Cmax) of Baseline-Adjusted Glucose
Time frame · Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Time frame · Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline-Adjusted Glucose From Time Zero up to 90 Minutes
Time frame · Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration

Secondary outcomes(3)

Nasal and Non-nasal Effects/Symptoms
Time frame · Pre-dose;15, 30, 60 and 90 minutes following glucagon administration
Registry description
Symptoms of runny nose, nasal congestion and/or itching, sneezing, watery and/or itchy eyes, redness of eyes, and itching of ears and/or throat were assessed prior to administering glucagon and at 15, 30, 60 and 90 minutes following administration of glucagon. This was done via the "Nasal Non-nasal Score Questionnaire". Each of the 9 symptoms is assigned an integer value from 0 to 3; higher values indicate more severe symptoms (a score of 0 indicates no symptoms). The reported results indicate the cohort median out of a possible maximum value of 27 (summing all 9 questions for each participant and reporting the median/IQR across participants).
Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes
Time frame · Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration
Time to Achieving ≥25 mg/dL Rise in Plasma Glucose Above Nadir Level Within 30 Minutes
Time frame · Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration
Registry description
Time (in minutes) when all participants experienced a rise in glucose \>=25mg/dL. This is an absolute number and is not a calculated statistic. There is no distribution per cohort.

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 outcomeMean· Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration

Maximum Change From Baseline Concentration (Cmax) of Glucagon

Group	Value (picograms per millilitre (pg/mL))	Spread
4 to<8 Years Old IM Glucagon Visit	6290.33	2045.96
4 to<8 Years Old NG Visit 2.0 mg	3463.55	1760.28
4 to<8 Years Old NG Visit 3.0 mg	3958.58	2438.60
8 to <12 Years Old IM Glucagon Visit	4743.00	3094.61
8 to<12 Years Old NG Visit 2.0 mg	2776.27	979.28
8 to<12 Years Old NG Visit 3.0 mg	5664.33	2114.69
12 to <17 Years Old IM Glucagon Visit	4277.25	3774.77
12 to<17 Years Old NG Visit 3.0 mg	3103.25	2302.61

Primary outcomeMedian· Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration

Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon

Group	Value (hours (hr))
4 to<8 Years Old IM Glucagon Visit	0.29
4 to<8 Years Old NG Visit 2.0 mg	0.25
4 to<8 Years Old NG Visit 3.0 mg	0.29
8 to <12 Years Old IM Glucagon Visit	0.29
8 to<12 Years Old NG Visit 2.0 mg	0.25
8 to<12 Years Old NG Visit 3.0 mg	0.25
12 to <17 Years Old IM Glucagon Visit	0.29
12 to<17 Years Old NG Visit 3.0 mg	0.33

Primary outcomeMean· Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration

Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon

Group	Value (hourpicogram per millilitre (hrpg/mL))	Spread
4 to<8 Years Old IM Glucagon Visit	4078.68	2078.89
4 to<8 Years Old NG Visit 2.0 mg	1744.36	978.81
4 to<8 Years Old NG Visit 3.0 mg	2472.40	1435.45
8 to <12 Years Old IM Glucagon Visit	3635.77	2069.11
8 to<12 Years Old NG Visit 2.0 mg	1506.23	541.57
8 to<12 Years Old NG Visit 3.0 mg	2939.31	1042.03
12 to <17 Years Old IM Glucagon Visit	3110.22	2848.75
12 to<17 Years Old NG Visit 3.0 mg	1999.69	1329.44

Primary outcomeMean· Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration

Maximum Concentration (Cmax) of Baseline-Adjusted Glucose

Group	Value (mg/dL)	Spread
4 to<8 Years Old IM Glucagon Visit	138.17	26.57
4 to<8 Years Old NG Visit 2.0 mg	118.18	46.46
4 to<8 Years Old NG Visit 3.0 mg	137.50	42.14
8 to <12 Years Old IM Glucagon Visit	130.50	21.81
8 to<12 Years Old NG Visit 2.0 mg	125.09	23.81
8 to<12 Years Old NG Visit 3.0 mg	132.82	30.59
12 to <17 Years Old IM Glucagon Visit	123.17	29.58
12 to<17 Years Old NG Visit 3.0 mg	102.33	25.63

Primary outcomeMedian· Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration

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

Group	Value (hours (hr))
4 to<8 Years Old IM Glucagon Visit	1.00
4 to<8 Years Old NG Visit 2.0 mg	0.67
4 to<8 Years Old NG Visit 3.0 mg	1.00
8 to <12 Years Old IM Glucagon Visit	1.50
8 to<12 Years Old NG Visit 2.0 mg	1.00
8 to<12 Years Old NG Visit 3.0 mg	1.00
12 to <17 Years Old IM Glucagon Visit	1.00
12 to<17 Years Old NG Visit 3.0 mg	1.00

Primary outcomeMean· Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration

Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline-Adjusted Glucose From Time Zero up to 90 Minutes

Group	Value (hr*mg/dL)	Spread
4 to<8 Years Old IM Glucagon Visit	145.86	26.94
4 to<8 Years Old NG Visit 2.0 mg	118.82	60.73
4 to<8 Years Old NG Visit 3.0 mg	142.38	51.98
8 to <12 Years Old IM Glucagon Visit	132.42	22.14
8 to<12 Years Old NG Visit 2.0 mg	128.82	28.45
8 to<12 Years Old NG Visit 3.0 mg	138.12	35.24
12 to <17 Years Old IM Glucagon Visit	126.94	30.40
12 to<17 Years Old NG Visit 3.0 mg	101.46	27.38

Secondary and other outcome results(2)

Secondary outcomeMedian· Pre-dose;15, 30, 60 and 90 minutes following glucagon administration

Nasal and Non-nasal Effects/Symptoms

Group	Value (units on a scale)
4 to<8 Years Old IM Glucagon Visit	0.50
4 to<8 Years Old NG Visit 2.0 mg	0.00
4 to<8 Years Old NG Visit 3.0 mg	0.00
8 to <12 Years Old IM Glucagon Visit	0.00
8 to<12 Years Old NG Visit 2.0 mg	0.00
8 to<12 Years Old NG Visit 3.0 mg	0.00
12 to <17 Years Old IM Glucagon Visit	0.00
12 to<17 Years Old NG Visit 3.0 mg	0.50

Secondary outcomeCount of participants· Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration

Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes

Group	Value (Participants)
4 to<8 Years Old IM Glucagon Visit	6
4 to<8 Years Old NG Visit 2.0 mg	11
4 to<8 Years Old NG Visit 3.0 mg	12
8 to <12 Years Old IM Glucagon Visit	6
8 to<12 Years Old NG Visit 2.0 mg	11
8 to<12 Years Old NG Visit 3.0 mg	12
12 to <17 Years Old IM Glucagon Visit	12
12 to<17 Years Old NG Visit 3.0 mg	12

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
4 to<8 Years Old IM Glucagon VisitParticipants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.	–	1 / 6	5 / 6
4 to<8 Years Old NG Visit 2.0 mgNG dose of 2.0 mg for participants 4 to less than 8 years of age.	–	0 / 12	6 / 12
4 to<8 Years Old NG Visit 3.0 mgNG dose of 3.0 mg for participants 4 to less than 8 years of age.	–	0 / 12	5 / 12
8 to <12 Years Old IM Glucagon VisitParticipants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.	–	0 / 6	6 / 6
8 to<12 Years Old NG Visit 2.0 mgNG of 2.0 mg for participants 8 to less than 12 years of age.	–	0 / 11	5 / 11
8 to<12 Years Old NG Visit 3.0 mgNG dose of 3.0 mg for participants 8 to less than 12 years of age.	–	0 / 12	6 / 12
12 to <17 Years Old IM Glucagon VisitParticipants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.	–	0 / 12	7 / 12
12 to<17 Years Old NG Visit 3.0 mgNG dose of 3.0 mg for participants 12 to less than 17 years of age.	–	0 / 12	9 / 12

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

Indexing hint: Randomized controlled trial · 2016

7 results

Glucagon Nasal Powder: A Promising Alternative to Intramuscular Glucagon in Youth With Type 1 Diabetes.

Sherr et al. 2016Diabetes carecited by 85

PMID 26884472PMC4806770DOI 10.2337/dc15-1606PUB-26884472

Rights unknown7 results

Source link See results (7)

Eligibility

Who could join, as posted.

Sex: All
Age: from 4 Years up to 16 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: To be eligible, the following inclusion criteria were met: * History of type 1 diabetes and receiving daily insulin therapy from the time of diagnosis for at least 12 months * At least 4 years of age and less than 17 years * Females must have met one of the following criteria: * Of childbearing potential but agreed to use an accepted contraceptive regimen as described in the study procedure manual throughout the entire duration of the study (from screening until study completion) * Of non-childbearing potential, defined as a female who had a hysterectomy or tubal ligation, was clinically considered infertile or had not yet reached menarche * In good general health with no conditions that could have influenced the outcome of the trial, and in the judgment of the Investigator was a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations * Willingness to adhere to the study requirements Exclusion Criteria: An individual was not eligible if any of the following exclusion criteria were present: * Females who were pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or were lactating * History of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs * Presence of cardiovascular, gastrointestinal, liver or kidney disease, or any other conditions which in the judgment of the investigator could have interfered with the absorption, distribution, metabolism or excretion of drugs or could potentiate or predispose to undesired effects * History of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma * History of an episode of severe hypoglycemia (as defined by an episode that required third party assistance for treatment) in the 1 month prior to enrolling in the study * Use of daily systemic beta-blocker, indomethacin, warfarin or anticholinergic drugs * History of epilepsy or seizure disorder * Use of an Investigational Product in another clinical trial within the past 30 days * Blood donation in 3 months prior to first glucagon dosing

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