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Trial record 37 of 1485 for:    Type 1 Diabetes Mellitus 5

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

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ClinicalTrials.gov Identifier: NCT03339453
Recruitment Status : Completed
First Posted : November 13, 2017
Results First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Hypoglycemia
Diabetes Mellitus, Type 1
Interventions Drug: Nasal Glucagon
Drug: Intramuscular Glucagon
Enrollment 70
Recruitment Details  
Pre-assignment Details

In each period, either 3 milligram (mg) nasal glucagon (NG) or 1 mg intramuscular (IM) Glucagon was administered.

After a wash-out period of at least 1 day (24 hours) from the first period (first visit), participants crossed over to the alternate glucagon treatment in period 2 (second visit).

Arm/Group Title NG 1st/IM Glucagon 2nd IM Glucagon 1st/NG 2nd
Hide Arm/Group Description Participants received 3 mg of NG at the first treatment visit followed by 1 mg of IM glucagon at the second treatment visit. Participants received 1 mg of IM glucagon at the first treatment visit followed by 3 mg of NG at the second treatment visit.
Period Title: First Visit of Glucagon Treatment
Started 35 35
Received at Least 1 Dose of Study Drug 35 35
Completed 35 34
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Period Title: Second Visit for Alternate Glucagon
Started 35 34
Completed [1] 35 34
Not Completed 0 0
[1]
Completed both inpatient study visits.
Arm/Group Title Glucagon
Hide Arm/Group Description All enrolled participants who received either 3 mg NG or 1 mg IM Glucagon.
Overall Number of Baseline Participants 70
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants
41.7  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Female 27
Male 43
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Hispanic or Latino 0
Not Hispanic or Latino 70
Unknown or Not Reported 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
American Indian or Alaska Native 0
Asian 0
Native Hawaiian or Other Pacific Islander 0
Black or African American 0
White 70
More than one race 0
Unknown or Not Reported 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 70 participants
70
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 70 participants
78.79  (13.28)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 70 participants
175.21  (8.43)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m2)
Number Analyzed 70 participants
25.53  (2.97)
1.Primary Outcome
Title Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia
Hide 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.
Time Frame Pre-dose up to 30 minutes post each glucagon administration
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed both treatment visits with evaluable data.
Arm/Group Title Nasal Glucagon (NG) IM Glucagon
Hide Arm/Group Description:
Dose of 3 mg nasal glucagon.
Dose of 1 mg IM glucagon.
Overall Number of Participants Analyzed 66 66
Measure Type: Count of Participants
Unit of Measure: Participants
66
 100.0%
66
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nasal Glucagon (NG), IM Glucagon
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments 95% Confidence Interval of the treatment differences in treatment success rate.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.52 to 1.52
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax)
Hide Description [Not Specified]
Time Frame Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of the study drug with evaluable PD data.
Arm/Group Title Nasal Glucagon (NG) IM Glucagon
Hide Arm/Group Description:
Dose of 3 mg nasal glucagon.
Dose of 1 mg IM glucagon.
Overall Number of Participants Analyzed 68 69
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Milligrams per deciliter (mg/dL)
132
(36%)
161
(29%)
3.Secondary Outcome
Title PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Hide Description [Not Specified]
Time Frame Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of the study drug with evaluable PD data.
Arm/Group Title Nasal Glucagon (NG) IM Glucagon
Hide Arm/Group Description:
Dose of 3 mg nasal glucagon.
Dose of 1 mg IM glucagon.
Overall Number of Participants Analyzed 68 69
Median (Full Range)
Unit of Measure: Hour (hr)
1.00
(0.42 to 1.50)
1.50
(0.83 to 1.50)
4.Secondary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Baseline Adjusted Glucagon
Hide Description [Not Specified]
Time Frame Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of the study drug with evaluable PK data.
Arm/Group Title Nasal Glucagon (NG) IM Glucagon
Hide Arm/Group Description:
Dose of 3 mg nasal glucagon.
Dose of 1 mg IM glucagon.
Overall Number of Participants Analyzed 63 66
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: picogram*hour per millilitre (pg*hr/mL)
2740
(68%)
3320
(40%)
5.Secondary Outcome
Title PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
Hide Description [Not Specified]
Time Frame Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of the study drug with evaluable PK data.
Arm/Group Title Nasal Glucagon (NG) IM Glucagon
Hide Arm/Group Description:
Dose of 3 mg nasal glucagon.
Dose of 1 mg IM glucagon.
Overall Number of Participants Analyzed 63 66
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: picograms per millilitre (pg/mL)
6130
(74%)
3750
(44%)
6.Secondary Outcome
Title PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Hide Description [Not Specified]
Time Frame Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of the study drug with evaluable PK data.
Arm/Group Title Nasal Glucagon (NG) IM Glucagon
Hide Arm/Group Description:
Dose of 3 mg nasal glucagon.
Dose of 1 mg IM glucagon.
Overall Number of Participants Analyzed 63 66
Median (Full Range)
Unit of Measure: Hour (hr)
0.25
(0.17 to 0.50)
0.25
(0.08 to 0.50)
Time Frame First dose of study drug (Day 1) until post-study completion (Day 30).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nasal Glucagon (NG) Intramuscular (IM) Glucagon
Hide Arm/Group Description Dose of 3 mg nasal glucagon. Dose of 1 mg intramuscular glucagon.
All-Cause Mortality
Nasal Glucagon (NG) Intramuscular (IM) Glucagon
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)      0/69 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Nasal Glucagon (NG) Intramuscular (IM) Glucagon
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/70 (0.00%)      0/69 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nasal Glucagon (NG) Intramuscular (IM) Glucagon
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/70 (48.57%)      35/69 (50.72%)    
Eye disorders     
Eye pain  1  1/70 (1.43%)  1 0/69 (0.00%)  0
Ocular discomfort  1  1/70 (1.43%)  1 0/69 (0.00%)  0
Gastrointestinal disorders     
Abdominal discomfort  1  1/70 (1.43%)  1 0/69 (0.00%)  0
Abdominal pain upper  1  0/70 (0.00%)  0 1/69 (1.45%)  1
Diarrhoea  1  0/70 (0.00%)  0 1/69 (1.45%)  1
Nausea  1  22/70 (31.43%)  22 29/69 (42.03%)  29
Vomiting  1  10/70 (14.29%)  10 12/69 (17.39%)  12
Infections and infestations     
Nasopharyngitis  1  4/70 (5.71%)  4 2/69 (2.90%)  2
Otitis media  1  0/70 (0.00%)  0 1/69 (1.45%)  1
Investigations     
Body temperature increased  1  0/70 (0.00%)  0 1/69 (1.45%)  1
Nervous system disorders     
Headache  1  11/70 (15.71%)  13 7/69 (10.14%)  7
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/70 (1.43%)  1 0/69 (0.00%)  0
Epistaxis  1  1/70 (1.43%)  1 0/69 (0.00%)  0
Nasal discomfort  1  0/70 (0.00%)  0 1/69 (1.45%)  1
Oropharyngeal pain  1  2/70 (2.86%)  2 0/69 (0.00%)  0
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  1/70 (1.43%)  1 0/69 (0.00%)  0
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03339453     History of Changes
Other Study ID Numbers: 16547
I8R-MC-IGBI ( Other Identifier: Eli Lilly and Company )
2017-000249-33 ( EudraCT Number )
First Submitted: November 8, 2017
First Posted: November 13, 2017
Results First Submitted: August 16, 2019
Results First Posted: September 23, 2019
Last Update Posted: September 23, 2019