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Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children

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ClinicalTrials.gov Identifier: NCT03667053
Recruitment Status : Completed
First Posted : September 12, 2018
Results First Posted : May 10, 2021
Last Update Posted : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
Zealand Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypoglycemia
Interventions Drug: dasiglucagon
Drug: placebo
Drug: GlucaGen HypoKit
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Hide Arm/Group Description

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of placebo

placebo: placebo for dasiglucagon

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Period Title: Overall Study
Started [1] 21 11 10
Randomized and Treated 20 11 10
Completed 20 11 10
Not Completed 1 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0
[1]
Randomized subjects
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg Total
Hide Arm/Group Description

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of placebo

placebo: placebo for dasiglucagon

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Total of all reporting groups
Overall Number of Baseline Participants 20 11 10 41
Hide Baseline Analysis Population Description
Safety analysis set of all randomized and treated participants. Treatment assignment was based on the treatment actually received.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 11 participants 10 participants 41 participants
<=18 years
20
 100.0%
11
 100.0%
10
 100.0%
41
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 11 participants 10 participants 41 participants
12.3  (3.42) 12.8  (3.25) 12.4  (3.50) 12.5  (3.32)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 11 participants 10 participants 41 participants
Age 6-11 years
8
  40.0%
4
  36.4%
4
  40.0%
16
  39.0%
Age 12-17 years
12
  60.0%
7
  63.6%
6
  60.0%
25
  61.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 11 participants 10 participants 41 participants
Female
10
  50.0%
6
  54.5%
2
  20.0%
18
  43.9%
Male
10
  50.0%
5
  45.5%
8
  80.0%
23
  56.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 11 participants 10 participants 41 participants
Hispanic or Latino
4
  20.0%
2
  18.2%
1
  10.0%
7
  17.1%
Not Hispanic or Latino
16
  80.0%
8
  72.7%
9
  90.0%
33
  80.5%
Unknown or Not Reported
0
   0.0%
1
   9.1%
0
   0.0%
1
   2.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 11 participants 10 participants 41 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
19
  95.0%
10
  90.9%
10
 100.0%
39
  95.1%
More than one race
1
   5.0%
0
   0.0%
0
   0.0%
1
   2.4%
Unknown or Not Reported
0
   0.0%
1
   9.1%
0
   0.0%
1
   2.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 11 participants 10 participants 41 participants
United States 13 9 7 29
Slovenia 6 2 3 11
Germany 1 0 0 1
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 20 participants 11 participants 10 participants 41 participants
51.54  (22.202) 54.95  (21.404) 48.81  (14.992) 51.79  (20.106)
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg per square meter
Number Analyzed 20 participants 11 participants 10 participants 41 participants
20.74  (6.057) 20.39  (4.885) 18.92  (2.617) 20.20  (5.050)
1.Primary Outcome
Title Time to Plasma Glucose Recovery
Hide Description

Plasma glucose recovery was defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline during the hypoglycemic clamp procedure without administration of rescue intravenous (IV) glucose. Patients who received rescue IV glucose before 45 minutes and patients not recovering within 45 minutes after dosing were censored at 45 minutes. Time to plasma glucose recovery was summarized for each treatment group using Kaplan Meier (KM) estimates together with the 95% confidence interval.

Note that the upper confidence limit for the placebo median was not estimable, but is set to 45 minutes (censored value) here.

Time Frame 0-45 minutes after dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (same as the safety analysis set) of all randomized and treated patients. Treatment assignment was based on the randomized treatment. Assignment to the stratification factor injection site was based on the planned and not the actual used injection site.
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of placebo

placebo: placebo for dasiglucagon

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Overall Number of Participants Analyzed 20 11 10
Median (95% Confidence Interval)
Unit of Measure: minutes
10.00
(8.00 to 12.00)
30.00
(20.00 to 45.00)
10.00
(8.00 to 12.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dasiglucagon 0.6 mg, Placebo
Comments The treatment group difference between dasiglucagon and placebo was evaluated inferentially using a pairwise two-sided log rank test stratified by injection site and age group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Plasma Glucose Recovery
Hide Description Plasma glucose recovery within 30 minutes, within 20 minutes, within 15 minutes, and within 10 minutes after study drug injection without administration of rescue intravenous (IV) glucose. Plasma glucose recovery was defined as the first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose.
Time Frame 0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (same as the safety analysis set) of all randomized and treated patients. Treatment assignment was based on the randomized treatment. Assignment to the stratification factor injection site was based on the planned and not the actual used injection site.
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of placebo

placebo: placebo for dasiglucagon

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Overall Number of Participants Analyzed 20 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
Glucose recovery at 30 minutes
20
 100.0%
6
  54.5%
10
 100.0%
Glucose recovery at 20 minutes
20
 100.0%
2
  18.2%
10
 100.0%
Glucose recovery at 15 minutes
19
  95.0%
0
   0.0%
10
 100.0%
Glucose recovery at 10 minutes
13
  65.0%
0
   0.0%
6
  60.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dasiglucagon 0.6 mg, Placebo
Comments The recovery rates of dasiglucagon and placebo were compared at each time point using a Cochran-Mantel-Haenszel test stratified by age group and injection site. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0073
Comments Assessed at 30 minutes. Note that p-value was 0.0005 at 10 minutes and <0.0001 at 15 and 20 minutes.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Plasma Glucose Changes From Baseline
Hide Description Plasma glucose changes from baseline within 30 minutes, within 20 minutes, within 15 minutes, and within 10 minutes after trial product injection or at the time of rescue intravenous (IV) glucose
Time Frame 0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (same as the safety analysis set) of all randomized and treated patients. Treatment assignment was based on the randomized treatment. Assignment to the stratification factor injection site was based on the planned and not the actual used injection site.
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of placebo

placebo: placebo for dasiglucagon

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Overall Number of Participants Analyzed 20 11 10
Mean (Standard Deviation)
Unit of Measure: mg/dL
At 30 minutes 98.459  (19.6527) 17.510  (15.6313) 85.225  (12.5052)
At 20 minutes 65.369  (15.2461) 7.322  (13.3543) 58.000  (10.5297)
At 15 minutes 45.342  (15.0860) 0.835  (11.1276) 40.631  (9.7317)
At 10 minutes 27.225  (13.6768) -3.405  (8.0276) 20.919  (6.7227)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dasiglucagon 0.6 mg, Placebo
Comments Change from baseline in plasma glucose at 30, 20, 15, and 10 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The p-value was <0.0001 at all time points (10, 15, 20 and 30 minutes)
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Pharmacodynamics - Area Under the Effect Curve (0-30 Minutes)
Hide Description Plasma glucose response as area under the effect curve above baseline from time 0 to 30 minutes (AUE0-30min). Plasma glucose was determined at pre-dose and at 4, 6, 8, 10, 12, 15, 17, 20, 30, and 45 minutes (and at 60 minutes if the patient weighed ≥21 kg) after dosing.
Time Frame 0-30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (same as the safety analysis set) of all randomized and treated patients. Treatment assignment was based on the randomized treatment. Assignment to the stratification factor injection site was based on the planned and not the actual used injection site.
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of placebo

placebo: placebo for dasiglucagon

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Overall Number of Participants Analyzed 20 11 10
Mean (Standard Deviation)
Unit of Measure: mmol*h/L
22.83  (6.126) 1.81  (4.641) 19.66  (3.410)
5.Secondary Outcome
Title Administration of Rescue IV Glucose Infusion After IMP Injection
Hide Description Number of patients receiving IV rescue glucose administration for hypoglycemia after administration of IMP. IV = intravenous. IMP = investigational medicinal product.
Time Frame 0-45 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (same as the full analysis set) of all randomized and treated patients.
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of placebo

placebo: placebo for dasiglucagon

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Overall Number of Participants Analyzed 20 11 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   9.1%
0
   0.0%
6.Secondary Outcome
Title Time to First IV Glucose Infusion After IMP Administration
Hide Description Time to first IV rescue glucose administration for hypoglycemia after administration of IMP. IV = intravenous. IMP = investigational medicinal product.
Time Frame 0-45 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Only the patient who received IV glucose administration is included.
Arm/Group Title Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of placebo

placebo: placebo for dasiglucagon

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Overall Number of Participants Analyzed 0 1 0
Measure Type: Number
Unit of Measure: minutes
12
7.Secondary Outcome
Title Pharmacokinetics: AUC0-30 Min
Hide Description Area under the plasma dasiglucagon or GlucaGen concentration versus time curve from 0 to 30 minutes post-dose. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Time Frame 0-30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (same as the safety analysis set) of all randomized and treated patients. Treatment assignment was based on the randomized treatment. Assignment to the stratification factor injection site was based on the planned and not the actual used injection site.
Arm/Group Title Dasiglucagon 0.6 mg GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Overall Number of Participants Analyzed 20 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pmol/L
376
(78.1%)
376
(63.3%)
8.Secondary Outcome
Title Pharmacokinetics: AUC0-300min
Hide Description Area under the plasma dasiglucagon or GlucaGen concentration versus time curve from 0 to 300 minutes post-dose. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Time Frame 0-300 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (same as the safety analysis set) of all randomized and treated patients. Treatment assignment was based on the randomized treatment. Assignment to the stratification factor injection site was based on the planned and not the actual used injection site.
Arm/Group Title Dasiglucagon 0.6 mg GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Overall Number of Participants Analyzed 20 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pmol/L
1810
(44.8%)
1370
(72.7%)
9.Secondary Outcome
Title Pharmacokinetics: AUC0-inf
Hide Description Area under the plasma dasiglucagon or GlucaGen concentration versus time curve from 0 to infinitely post-dose. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Time Frame 0-300 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (same as the safety analysis set) of all randomized and treated patients. Treatment assignment was based on the randomized treatment. Assignment to the stratification factor injection site was based on the planned and not the actual used injection site.
Arm/Group Title Dasiglucagon 0.6 mg GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Overall Number of Participants Analyzed 20 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*pmol/L
1850
(45.1%)
1530
(70.3%)
10.Secondary Outcome
Title Pharmacokinetics: Cmax
Hide Description Maximum of all valid plasma dasiglucagon or GlucaGen concentration measurements from 0 to 300 minutes post-dose. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Time Frame 0-300 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (same as the safety analysis set) of all randomized and treated patients. Treatment assignment was based on the randomized treatment. Assignment to the stratification factor injection site was based on the planned and not the actual used injection site.
Arm/Group Title Dasiglucagon 0.6 mg GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Overall Number of Participants Analyzed 20 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pmol/L
1160
(61.2%)
1120
(80%)
11.Secondary Outcome
Title Pharmacokinetics: Tmax
Hide Description Time to maximum of plasma dasiglucagon or GlucaGen concentration measurements. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Time Frame 0-300 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (same as the safety analysis set) of all randomized and treated patients. Treatment assignment was based on the randomized treatment. Assignment to the stratification factor injection site was based on the planned and not the actual used injection site.
Arm/Group Title Dasiglucagon 0.6 mg GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Overall Number of Participants Analyzed 20 10
Median (Full Range)
Unit of Measure: hours
0.35
(0.167 to 1.5)
0.333
(0.167 to 0.5)
12.Secondary Outcome
Title Pharmacokinetics: λz
Hide Description Terminal elimination rate constant of plasma dasiglucagon or GlucaGen. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Time Frame 0-300 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (same as the safety analysis set) of all randomized and treated patients. Treatment assignment was based on the randomized treatment. Assignment to the stratification factor injection site was based on the planned and not the actual used injection site.
Arm/Group Title Dasiglucagon 0.6 mg GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Overall Number of Participants Analyzed 20 10
Geometric Least Squares Mean (Geometric Coefficient of Variation)
Unit of Measure: 1/hour
1.11
(37.4%)
0.504
(27.2%)
13.Secondary Outcome
Title Pharmacokinetics: t½
Hide Description Terminal plasma elimination half-life of dasiglucagon or GlucaGen. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Time Frame 0-300 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (same as the safety analysis set) of all randomized and treated patients. Treatment assignment was based on the randomized treatment. Assignment to the stratification factor injection site was based on the planned and not the actual used injection site.
Arm/Group Title Dasiglucagon 0.6 mg GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Overall Number of Participants Analyzed 20 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
0.623
(37.4%)
1.38
(27.2%)
14.Secondary Outcome
Title Pharmacokinetics: CL/f
Hide Description Total body clearance of plasma dasiglucagon or GlucaGen. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Time Frame 0-300 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (same as the safety analysis set) of all randomized and treated patients. Treatment assignment was based on the randomized treatment. Assignment to the stratification factor injection site was based on the planned and not the actual used injection site.
Arm/Group Title Dasiglucagon 0.6 mg GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Overall Number of Participants Analyzed 20 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/h
96.1
(45.1%)
188
(70.3%)
15.Secondary Outcome
Title Pharmacokinetics: Vz/f
Hide Description Volume of distribution of plasma dasiglucagon or GlucaGen. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Time Frame 0-300 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (same as the safety analysis set) of all randomized and treated patients. Treatment assignment was based on the randomized treatment. Assignment to the stratification factor injection site was based on the planned and not the actual used injection site.
Arm/Group Title Dasiglucagon 0.6 mg GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Overall Number of Participants Analyzed 20 10
Geometric Least Squares Mean (Geometric Coefficient of Variation)
Unit of Measure: litres
86.4
(62.2%)
373
(81.1%)
16.Secondary Outcome
Title Pharmacokinetics: MRT
Hide Description Mean residence time of plasma dasiglucagon or GlucaGen. Samples were collected before dosing and at 10, 20, 30, 40, 60, 90, 140, 220, and 300 minutes after dosing.
Time Frame 0-300 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (same as the safety analysis set) of all randomized and treated patients. Treatment assignment was based on the randomized treatment. Assignment to the stratification factor injection site was based on the planned and not the actual used injection site.
Arm/Group Title Dasiglucagon 0.6 mg GlucaGen® 1.0 mg
Hide Arm/Group Description:

Single fixed dose (subcutaneous injection) of dasiglucagon

dasiglucagon: glucagon analog

Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)

GlucaGen HypoKit: native glucagon

Overall Number of Participants Analyzed 20 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
1.27
(29.5%)
1.86
(21.1%)
Time Frame Adverse events were collected from the first trial-related activity after the patient had signed the informed consent to the end of the follow-up period (28 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Age Group 6-11 Years - Dasiglucagon Age Group 6-11 Years - Placebo Age Group 6-11 Years - GlucaGen Age Group 12-17 Years - Dasiglucagon Age Group 12-17 Years - Placebo Age Group 12-17 Years - Glucagen Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Hide Arm/Group Description Patients in the dasiglucagon group in the age group 6-11 years Patients in the placebo group in the age group 6-11 years Patients in the GlucaGen group in the age group 6-11 years Patients in the dasiglucagon group in the age group 12-17 years Patients in the placebo group in the age group 12-17 years Patients in the GlucaGen group in the age group 12-17 years Full population. Single fixed dose (subcutaneous injection) of dasiglucagon Full population. Single fixed dose (subcutaneous injection) of placebo Full population. Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg)
All-Cause Mortality
Age Group 6-11 Years - Dasiglucagon Age Group 6-11 Years - Placebo Age Group 6-11 Years - GlucaGen Age Group 12-17 Years - Dasiglucagon Age Group 12-17 Years - Placebo Age Group 12-17 Years - Glucagen Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/12 (0.00%)      0/7 (0.00%)      0/6 (0.00%)      0/20 (0.00%)      0/11 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
Age Group 6-11 Years - Dasiglucagon Age Group 6-11 Years - Placebo Age Group 6-11 Years - GlucaGen Age Group 12-17 Years - Dasiglucagon Age Group 12-17 Years - Placebo Age Group 12-17 Years - Glucagen Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/12 (0.00%)      0/7 (0.00%)      0/6 (0.00%)      0/20 (0.00%)      0/11 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Age Group 6-11 Years - Dasiglucagon Age Group 6-11 Years - Placebo Age Group 6-11 Years - GlucaGen Age Group 12-17 Years - Dasiglucagon Age Group 12-17 Years - Placebo Age Group 12-17 Years - Glucagen Dasiglucagon 0.6 mg Placebo GlucaGen® 1.0 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/8 (37.50%)      1/4 (25.00%)      4/4 (100.00%)      12/12 (100.00%)      6/7 (85.71%)      5/6 (83.33%)      15/20 (75.00%)      7/11 (63.64%)      9/10 (90.00%)    
Blood and lymphatic system disorders                   
Leukopenia  1  0/8 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0 1/20 (5.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0
Thrombocytopenia  1  0/8 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/20 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0
Gastrointestinal disorders                   
Nausea  1  2/8 (25.00%)  2 0/4 (0.00%)  0 2/4 (50.00%)  2 11/12 (91.67%)  12 0/7 (0.00%)  0 1/6 (16.67%)  1 13/20 (65.00%)  14 0/11 (0.00%)  0 3/10 (30.00%)  3
Vomiting  1  2/8 (25.00%)  2 0/4 (0.00%)  0 1/4 (25.00%)  1 8/12 (66.67%)  11 0/7 (0.00%)  0 0/6 (0.00%)  0 10/20 (50.00%)  13 0/11 (0.00%)  0 1/10 (10.00%)  1
General disorders                   
Injection site erythema  1  0/8 (0.00%)  0 0/4 (0.00%)  0 2/4 (50.00%)  2 0/12 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/20 (0.00%)  0 0/11 (0.00%)  0 3/10 (30.00%)  3
Injection site pain  1  0/8 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0 1/6 (16.67%)  1 1/20 (5.00%)  1 0/11 (0.00%)  0 1/10 (10.00%)  1
Injection site edema  1  0/8 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/12 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/20 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1
Injection site induration  1  0/8 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/12 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/20 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1
Infusion site bruising  1  0/8 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/20 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0
Infusion site pain  1  0/8 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/20 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1
Infections and infestations                   
Upper respiratory tract infection  1  0/8 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 2/12 (16.67%)  3 0/7 (0.00%)  0 0/6 (0.00%)  0 2/20 (10.00%)  3 0/11 (0.00%)  0 0/10 (0.00%)  0
Gastroenteritis  1  0/8 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/20 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0
Sinusitis  1  0/8 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/20 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0
Metabolism and nutrition disorders                   
Hypoglycemia  1  1/8 (12.50%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 1/12 (8.33%)  1 4/7 (57.14%)  16 2/6 (33.33%)  2 2/20 (10.00%)  2 4/11 (36.36%)  16 2/10 (20.00%)  2
Nervous system disorders                   
Headache  1  0/8 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 2/12 (16.67%)  2 1/7 (14.29%)  1 0/6 (0.00%)  0 2/20 (10.00%)  2 1/11 (9.09%)  1 1/10 (10.00%)  1
Renal and urinary disorders                   
Urinary incontinence  1  0/8 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/20 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders                   
Rash  1  0/8 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/20 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1
Vascular disorders                   
Hypertension  1  0/8 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/20 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr Kim Mark Knudsen
Organization: Zealand Pharma A/S
Phone: +4550603780
EMail: KMKnudsen@zealandpharma.com
Layout table for additonal information
Responsible Party: Zealand Pharma
ClinicalTrials.gov Identifier: NCT03667053    
Other Study ID Numbers: ZP4207-17086
First Submitted: September 7, 2018
First Posted: September 12, 2018
Results First Submitted: April 13, 2021
Results First Posted: May 10, 2021
Last Update Posted: June 30, 2021