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

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ClinicalTrials.gov Identifier: NCT01997411
Recruitment Status : Completed
First Posted : November 28, 2013
Results First Posted : March 6, 2017
Last Update Posted : August 29, 2018
Sponsor:
Collaborators:
Jaeb Center for Health Research
Locemia Solutions ULC
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 1
Interventions: Drug: Nasal Glucagon
Drug: Intramuscular Glucagon

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
4 to<8 Years Old Intramuscular (IM) Glucagon Visit

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 Ibs, IM glucagon dose was 0.5 mg.

This was completed at one visit and was the only visit for this cohort.

4 to <8 Years Old NG 2.0 mg 1st Visit/3.0 mg 2nd Visit

At the first visit, a nasal glucagon (NG) dose of 2.0 milligrams (mg) for participants 4 to less than 8 years of age was administered nasally.

At the second visit, NG dose of 3.0 mg was administered nasally.

4 to <8 Years Old NG 3.0 mg 1st Visit/2.0 mg 2nd Visit

At the first visit, a NG dose of 3.0 mg for participants 4 to less than 8 years of age was administered nasally.

At the second visit, a NG dose of 2.0 mg was administered nasally.

8 to <12 Years Old Intramuscular Glucagon Visit Participants who weighed at least 25 kilograms 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. This was completed at one visit and was the only visit for this cohort.
8 to <12 Years Old NG 2.0 mg 1st Visit/3.0 mg 2nd Visit

At the first visit, a NG dose of 2.0 mg for participants 8 to less than 12 years of age was administered nasally.

At the second visit, a NG dose of 3.0 mg was administered nasally.

8 to <12 Years Old NG 3.0 mg 1st Visit/2.0 mg 2nd Visit

At the first visit, a NG dose of 3.0 mg for participants 8 to less than 12 years of age was administered nasally.

At the second visit, a NG dose of 2.0 mg was administered nasally.

12 to <17 Years Old NG 1st Visit/IM Glucagon 2nd Visit

At the first visit, a NG dose of 3.0 mg was administered nasally.

At the second visit, participants 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.

12 to <17 Years Old IM Glucagon 1st Visit/NG 2nd Visit

At the first visit, participants 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.

At the second visit, a NG dose of 3.0 mg was administered nasally.


Participant Flow:   Overall Study
    4 to<8 Years Old Intramuscular (IM) Glucagon Visit   4 to <8 Years Old NG 2.0 mg 1st Visit/3.0 mg 2nd Visit   4 to <8 Years Old NG 3.0 mg 1st Visit/2.0 mg 2nd Visit   8 to <12 Years Old Intramuscular Glucagon Visit   8 to <12 Years Old NG 2.0 mg 1st Visit/3.0 mg 2nd Visit   8 to <12 Years Old NG 3.0 mg 1st Visit/2.0 mg 2nd Visit   12 to <17 Years Old NG 1st Visit/IM Glucagon 2nd Visit   12 to <17 Years Old IM Glucagon 1st Visit/NG 2nd Visit
STARTED   6   6   6   6   6   6   6   6 
COMPLETED   6   6   6   6   6   5   6   6 
NOT COMPLETED   0   0   0   0   0   1   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
4 to <8 Years Old IM Glucagon Cohort Participants who were 4 to < 8 years old at the time of enrollment into the study randomized to receive only the intramuscular glucagon at one visit.
4 to <8 Years Old NG Cohort Participants who were 4 to < 8 years old at the time of enrollment into the study randomized to receive 2.0 or 3.0 mg of nasal glucagon at two separate visits. Order of these visits was randomized.
8 to <12 Years Old IM Glucagon Cohort Participants who were 8 to < 12 years old at the time of enrollment into the study randomized to receive only the intramuscular glucagon at one visit.
8 to <12 Years Old NG Cohort Participants who were 8 to < 12 years old at the time of enrollment into the study randomized to receive 2.0 or 3.0 mg of nasal glucagon at two separate visits. Order of these visits was randomized.
12 to <17 Years Old NG/IM Cohort Participants who were 12 to < 17 years old at the time of enrollment into the study randomized to receive either intramuscular glucagon or nasal glucagon at two separate visits. Order of these visits was randomized.
Total Total of all reporting groups

Baseline Measures
   4 to <8 Years Old IM Glucagon Cohort   4 to <8 Years Old NG Cohort   8 to <12 Years Old IM Glucagon Cohort   8 to <12 Years Old NG Cohort   12 to <17 Years Old NG/IM Cohort   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   12   6   12   12   48 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 6.8 
 (5.7 to 7.5) 
 6.8 
 (5.7 to 7.5) 
 11.1 
 (10.5 to 11.8) 
 11.1 
 (10.5 to 11.8) 
 14.5 
 (13.2 to 15.8) 
 10.6 
 (7.4 to 12.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female   0   3   3   5   5   16 
Male   6   9   3   7   7   32 
Region of Enrollment 
[Units: Participants]
Count of Participants
           
United States   6   12   6   12   12   48 
Local HbA1c 
[Units: Percent]
Mean (Standard Deviation)
 7.6  (0.5)   8.3  (0.8)   7.5  (1.1)   8.1  (0.7)   8.2  (1.5)   8.0  (1.0) 
Duration of Diabetes 
[Units: Years]
Median (Inter-Quartile Range)
 3.1 
 (2.1 to 3.8) 
 2.7 
 (1.8 to 3.6) 
 5.3 
 (3.9 to 6.3) 
 4.3 
 (3.4 to 6.7) 
 5.9 
 (3.5 to 8.0) 
 3.9 
 (2.6 to 6.0) 


  Outcome Measures

1.  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 ]

2.  Primary:   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 ]

3.  Primary:   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 ]

4.  Primary:   Maximum Concentration (Cmax) of Baseline-Adjusted Glucose   [ Time Frame: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration ]

5.  Primary:   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 ]

6.  Primary:   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 ]

7.  Secondary:   Nasal and Non-nasal Effects/Symptoms   [ Time Frame: Pre-dose;15, 30, 60 and 90 minutes following glucagon administration ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Other Pre-specified:   Percentage of Participants With >= 25 mg/dL Rise in Plasma Glucose Within 30 Minutes   [ Time Frame: Pre-dose; 5, 10,15, 20, and 30 minutes following glucagon administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01997411     History of Changes
Other Study ID Numbers: 16418
I8R-MC-IGBB ( Other Identifier: Eli Lilly and Company )
INGluc002 ( Other Identifier: Jaeb Center for Health Research )
AMG103 ( Other Identifier: Locemia )
First Submitted: November 22, 2013
First Posted: November 28, 2013
Results First Submitted: September 2, 2016
Results First Posted: March 6, 2017
Last Update Posted: August 29, 2018