Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes
4 other identifiers
interventional
48
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2013
Shorter than P25 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 22, 2013
CompletedFirst Posted
Study publicly available on registry
November 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
March 6, 2017
CompletedAugust 29, 2018
August 1, 2018
1.2 years
November 22, 2013
September 2, 2016
August 1, 2018
Conditions
Outcome Measures
Primary Outcomes (6)
Maximum Change From Baseline Concentration (Cmax) of Glucagon
Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
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
Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Maximum Concentration (Cmax) of Baseline-Adjusted Glucose
Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
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
Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Secondary Outcomes (3)
Nasal and Non-nasal Effects/Symptoms
Pre-dose;15, 30, 60 and 90 minutes following glucagon administration
Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes
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
Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration
Other Outcomes (1)
Percentage of Participants With >= 25 mg/dL Rise in Plasma Glucose Within 30 Minutes
Pre-dose; 5, 10,15, 20, and 30 minutes following glucagon administration
Study Arms (2)
Nasal Glucagon (NG)
EXPERIMENTALNasal 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.
Intramuscular (IM) Glucagon
ACTIVE COMPARATORParticipants 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Jaeb Center for Health Researchcollaborator
- Locemia Solutions ULCcollaborator
Study Sites (7)
Barbara Davis Center for Diabetes
Aurora, Colorado, 80045, United States
Yale University
New Haven, Connecticut, 06520, United States
University of Florida
Gainesville, Florida, 32605, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
Riley Hospital for Children Indiana University Health
Indianapolis, Indiana, 46202, United States
University of Minnesota
Minneapolis, Minnesota, 55454, United States
UPA Buffalo
Buffalo, New York, 14222, United States
Related Publications (1)
Sherr JL, Ruedy KJ, Foster NC, Piche CA, Dulude H, Rickels MR, Tamborlane WV, Bethin KE, DiMeglio LA, Fox LA, Wadwa RP, Schatz DA, Nathan BM, Marcovina SM, Rampakakis E, Meng L, Beck RW; T1D Exchange Intranasal Glucagon Investigators. Glucagon Nasal Powder: A Promising Alternative to Intramuscular Glucagon in Youth With Type 1 Diabetes. Diabetes Care. 2016 Apr;39(4):555-62. doi: 10.2337/dc15-1606. Epub 2016 Feb 16.
PMID: 26884472DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- IM and NG arms are open labeled. NG cohorts, 2mg and 3mg, are quadruple blinded.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2013
First Posted
November 28, 2013
Study Start
November 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
August 29, 2018
Results First Posted
March 6, 2017
Record last verified: 2018-08