ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01997411
Recruitment Status : Completed
First Posted : November 28, 2013
Results First Posted : March 6, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Jaeb Center for Health Research

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 1
Interventions: Drug: Intranasal Glucagon
Drug: 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 Glucagon Visit Participants who weighed at least 25 kg (55) lbs were given an intramuscular (IM) dose of 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
4 to <8 Years IN Glucagon 2.0 mg 1st Visit/3.0 mg 2nd Visit

At the first visit, an intranasal (IN) glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

At the second visit, an IN glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

4 to <8 Years IN Glucagon 3.0 mg 1st Visit/2.0 mg 2nd Visit

At the first visit, an intranasal (IN) glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

At the second visit, an IN glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

8 to <12 Years Old Intramuscular Glucagon Visit Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
8 to <12 Years IN Glucagon 2.0 mg 1st Visit/3.0 mg 2nd Visit

At the first visit, an intranasal (IN) glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

At the second visit, an IN glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

8 to <12 Years IN Glucagon 3.0 mg 1st Visit/2.0 mg 2nd Visit

At the first visit, an intranasal (IN) glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

At the second visit, an IN glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

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

At the first visit, an intranasal (IN) glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.

At the second visit, participants who weighed at least 25 kg (55) lbs were given an intramuscular (IM) dose of 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.

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

At the first visit, participants who weighed at least 25 kg (55) lbs were given an intramuscular (IM) dose of 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.

At the second visit, an intranasal (IN) glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.


Participant Flow:   Overall Study
    4 to<8 Years Old Intramuscular Glucagon Visit   4 to <8 Years IN Glucagon 2.0 mg 1st Visit/3.0 mg 2nd Visit   4 to <8 Years IN Glucagon 3.0 mg 1st Visit/2.0 mg 2nd Visit   8 to <12 Years Old Intramuscular Glucagon Visit   8 to <12 Years IN Glucagon 2.0 mg 1st Visit/3.0 mg 2nd Visit   8 to <12 Years IN Glucagon 3.0 mg 1st Visit/2.0 mg 2nd Visit   12 to <17 Years IN Glucagon 1st Visit/IM Glucagon 2nd Visit   12 to <17 Years IM Glucagon 1st Visit/IN Glucagon 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 Intramuscular 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 Intranasal Glucagon 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 intranasal glucagon at two separate visits. Order of these visits was randomized.
8 to <12 Years Old Intramuscular 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 Intranasal Glucagon 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 intranasal glucagon at two separate visits. Order of these visits was randomized.
12 to <17 Years Old IN/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 intranasal glucagon at two separate visits. Order of these visits was randomized.
Total Total of all reporting groups

Baseline Measures
   4 to <8 Years Old Intramuscular Glucagon Cohort   4 to <8 Years Old Intranasal Glucagon Cohort   8 to <12 Years Old Intramuscular Glucagon Cohort   8 to <12 Years Old Intranasal Glucagon Cohort   12 to <17 Years Old IN/IM Cohort   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   12   6   12   12   48 
Age 
[Units: Years]
Mean (Standard Deviation)
 6.1  (1.6)   6.7  (1.0)   11.1  (1.0)   11.1  (0.6)   14.6  (1.6)   10.2  (3.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      0   0.0%      3  25.0%      3  50.0%      5  41.7%      5  41.7%      16  33.3% 
Male      6 100.0%      9  75.0%      3  50.0%      7  58.3%      7  58.3%      32  66.7% 
Region of Enrollment 
[Units: 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:   Percentage of Participants With >= 25 mg/dL Rise in Plasma Glucose   [ Time Frame: 0 to 20 minutes following administration of glucagon ]

2.  Primary:   Maximum Observed Concentration (Cmax) of Glucagon   [ Time Frame: 0 to 90 minutes following glucagon administration ]

3.  Primary:   Time to Maximum Concentration (Tmax) of Glucagon   [ Time Frame: 0 to 90 minutes following glucagon administration ]

4.  Secondary:   Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Glucagon   [ Time Frame: 0 to 90 minutes following administration of glucagon ]

5.  Secondary:   Nasal and Non-nasal Effects/Symptoms   [ Time Frame: Timepoints of 15 minutes, 30 minutes, 60 minutes, and 90 minutes post glucagon administration ]

6.  Secondary:   Maximum Concentration (Cmax) of Glucose   [ Time Frame: 0 to 90 minutes following glucagon administration ]

7.  Secondary:   Time to Maximum Concentration (Tmax) of Glucose   [ Time Frame: 0 to 90 minutes following glucagon administration ]

8.  Secondary:   Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Glucose From Time Zero up to 90 Minutes   [ Time Frame: 0 to 90 minutes following glucagon administration ]

9.  Secondary:   The Proportion and 99% Confidence Interval of Participants Achieving at Least a 25 mg/dl Rise in Blood Glucose Above Basal Level   [ Time Frame: 0 to 90 minutes following glucagon administration ]

10.  Secondary:   Time to Achieving ≥25 mg/dl Rise in Plasma Glucose Above Basal Level   [ Time Frame: 0 to 90 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: Katrina Ruedy
Organization: Jaeb Center for Health Research
phone: 8139758690
e-mail: kruedy@jaeb.org


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

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT01997411     History of Changes
Other Study ID Numbers: INGluc002
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: April 4, 2017