Trial Outcomes & Findings for Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children (NCT NCT03667053)
NCT ID: NCT03667053
Last Updated: 2021-06-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
42 participants
Primary outcome timeframe
0-45 minutes after dosing
Results posted on
2021-06-30
Participant Flow
Participant milestones
| Measure |
Dasiglucagon 0.6 mg
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
11
|
10
|
|
Overall Study
Randomized and Treated
|
20
|
11
|
10
|
|
Overall Study
COMPLETED
|
20
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dasiglucagon 0.6 mg
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children
Baseline characteristics by cohort
| Measure |
Dasiglucagon 0.6 mg
n=20 Participants
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
n=11 Participants
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
n=10 Participants
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
12.3 years
STANDARD_DEVIATION 3.42 • n=5 Participants
|
12.8 years
STANDARD_DEVIATION 3.25 • n=7 Participants
|
12.4 years
STANDARD_DEVIATION 3.50 • n=5 Participants
|
12.5 years
STANDARD_DEVIATION 3.32 • n=4 Participants
|
|
Age, Customized
Age 6-11 years
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age, Customized
Age 12-17 years
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
7 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Region of Enrollment
Slovenia
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Body weight
|
51.54 kg
STANDARD_DEVIATION 22.202 • n=5 Participants
|
54.95 kg
STANDARD_DEVIATION 21.404 • n=7 Participants
|
48.81 kg
STANDARD_DEVIATION 14.992 • n=5 Participants
|
51.79 kg
STANDARD_DEVIATION 20.106 • n=4 Participants
|
|
Body mass index
|
20.74 kg per square meter
STANDARD_DEVIATION 6.057 • n=5 Participants
|
20.39 kg per square meter
STANDARD_DEVIATION 4.885 • n=7 Participants
|
18.92 kg per square meter
STANDARD_DEVIATION 2.617 • n=5 Participants
|
20.20 kg per square meter
STANDARD_DEVIATION 5.050 • n=4 Participants
|
PRIMARY outcome
Timeframe: 0-45 minutes after dosingPopulation: 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.
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.
Outcome measures
| Measure |
Dasiglucagon 0.6 mg
n=20 Participants
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
n=11 Participants
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
n=10 Participants
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Time to Plasma Glucose Recovery
|
10.00 minutes
Interval 8.0 to 12.0
|
30.00 minutes
Interval 20.0 to 45.0
|
10.00 minutes
Interval 8.0 to 12.0
|
SECONDARY outcome
Timeframe: 0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injectionPopulation: 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.
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.
Outcome measures
| Measure |
Dasiglucagon 0.6 mg
n=20 Participants
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
n=11 Participants
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
n=10 Participants
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Plasma Glucose Recovery
Glucose recovery at 30 minutes
|
20 Participants
|
6 Participants
|
10 Participants
|
|
Plasma Glucose Recovery
Glucose recovery at 20 minutes
|
20 Participants
|
2 Participants
|
10 Participants
|
|
Plasma Glucose Recovery
Glucose recovery at 15 minutes
|
19 Participants
|
0 Participants
|
10 Participants
|
|
Plasma Glucose Recovery
Glucose recovery at 10 minutes
|
13 Participants
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injectionPopulation: 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.
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
Outcome measures
| Measure |
Dasiglucagon 0.6 mg
n=20 Participants
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
n=11 Participants
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
n=10 Participants
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Plasma Glucose Changes From Baseline
At 30 minutes
|
98.459 mg/dL
Standard Deviation 19.6527
|
17.510 mg/dL
Standard Deviation 15.6313
|
85.225 mg/dL
Standard Deviation 12.5052
|
|
Plasma Glucose Changes From Baseline
At 20 minutes
|
65.369 mg/dL
Standard Deviation 15.2461
|
7.322 mg/dL
Standard Deviation 13.3543
|
58.000 mg/dL
Standard Deviation 10.5297
|
|
Plasma Glucose Changes From Baseline
At 15 minutes
|
45.342 mg/dL
Standard Deviation 15.0860
|
0.835 mg/dL
Standard Deviation 11.1276
|
40.631 mg/dL
Standard Deviation 9.7317
|
|
Plasma Glucose Changes From Baseline
At 10 minutes
|
27.225 mg/dL
Standard Deviation 13.6768
|
-3.405 mg/dL
Standard Deviation 8.0276
|
20.919 mg/dL
Standard Deviation 6.7227
|
SECONDARY outcome
Timeframe: 0-30 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Dasiglucagon 0.6 mg
n=20 Participants
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
n=11 Participants
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
n=10 Participants
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Pharmacodynamics - Area Under the Effect Curve (0-30 Minutes)
|
22.83 mmol*h/L
Standard Deviation 6.126
|
1.81 mmol*h/L
Standard Deviation 4.641
|
19.66 mmol*h/L
Standard Deviation 3.410
|
SECONDARY outcome
Timeframe: 0-45 minutesPopulation: Safety analysis set (same as the full analysis set) of all randomized and treated patients.
Number of patients receiving IV rescue glucose administration for hypoglycemia after administration of IMP. IV = intravenous. IMP = investigational medicinal product.
Outcome measures
| Measure |
Dasiglucagon 0.6 mg
n=20 Participants
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
n=11 Participants
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
n=10 Participants
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Administration of Rescue IV Glucose Infusion After IMP Injection
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0-45 minutesPopulation: Only the patient who received IV glucose administration is included.
Time to first IV rescue glucose administration for hypoglycemia after administration of IMP. IV = intravenous. IMP = investigational medicinal product.
Outcome measures
| Measure |
Dasiglucagon 0.6 mg
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
n=1 Participants
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Time to First IV Glucose Infusion After IMP Administration
|
—
|
12 minutes
|
—
|
SECONDARY outcome
Timeframe: 0-30 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Dasiglucagon 0.6 mg
n=20 Participants
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
n=10 Participants
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Pharmacokinetics: AUC0-30 Min
|
376 h*pmol/L
Geometric Coefficient of Variation 78.1
|
376 h*pmol/L
Geometric Coefficient of Variation 63.3
|
—
|
SECONDARY outcome
Timeframe: 0-300 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Dasiglucagon 0.6 mg
n=20 Participants
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
n=10 Participants
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Pharmacokinetics: AUC0-300min
|
1810 h*pmol/L
Geometric Coefficient of Variation 44.8
|
1370 h*pmol/L
Geometric Coefficient of Variation 72.7
|
—
|
SECONDARY outcome
Timeframe: 0-300 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Dasiglucagon 0.6 mg
n=20 Participants
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
n=10 Participants
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Pharmacokinetics: AUC0-inf
|
1850 h*pmol/L
Geometric Coefficient of Variation 45.1
|
1530 h*pmol/L
Geometric Coefficient of Variation 70.3
|
—
|
SECONDARY outcome
Timeframe: 0-300 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Dasiglucagon 0.6 mg
n=20 Participants
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
n=10 Participants
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Pharmacokinetics: Cmax
|
1160 pmol/L
Geometric Coefficient of Variation 61.2
|
1120 pmol/L
Geometric Coefficient of Variation 80
|
—
|
SECONDARY outcome
Timeframe: 0-300 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Dasiglucagon 0.6 mg
n=20 Participants
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
n=10 Participants
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Pharmacokinetics: Tmax
|
0.35 hours
Interval 0.167 to 1.5
|
0.333 hours
Interval 0.167 to 0.5
|
—
|
SECONDARY outcome
Timeframe: 0-300 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Dasiglucagon 0.6 mg
n=20 Participants
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
n=10 Participants
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Pharmacokinetics: λz
|
1.11 1/hour
Geometric Coefficient of Variation 37.4
|
0.504 1/hour
Geometric Coefficient of Variation 27.2
|
—
|
SECONDARY outcome
Timeframe: 0-300 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Dasiglucagon 0.6 mg
n=20 Participants
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
n=10 Participants
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Pharmacokinetics: t½
|
0.623 hours
Geometric Coefficient of Variation 37.4
|
1.38 hours
Geometric Coefficient of Variation 27.2
|
—
|
SECONDARY outcome
Timeframe: 0-300 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Dasiglucagon 0.6 mg
n=20 Participants
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
n=10 Participants
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Pharmacokinetics: CL/f
|
96.1 L/h
Geometric Coefficient of Variation 45.1
|
188 L/h
Geometric Coefficient of Variation 70.3
|
—
|
SECONDARY outcome
Timeframe: 0-300 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Dasiglucagon 0.6 mg
n=20 Participants
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
n=10 Participants
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Pharmacokinetics: Vz/f
|
86.4 litres
Geometric Coefficient of Variation 62.2
|
373 litres
Geometric Coefficient of Variation 81.1
|
—
|
SECONDARY outcome
Timeframe: 0-300 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Dasiglucagon 0.6 mg
n=20 Participants
Single fixed dose (subcutaneous injection) of dasiglucagon
dasiglucagon: glucagon analog
|
Placebo
n=10 Participants
Single fixed dose (subcutaneous injection) of placebo
placebo: placebo for dasiglucagon
|
GlucaGen® 1.0 mg
Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
GlucaGen HypoKit: native glucagon
|
|---|---|---|---|
|
Pharmacokinetics: MRT
|
1.27 hours
Geometric Coefficient of Variation 29.5
|
1.86 hours
Geometric Coefficient of Variation 21.1
|
—
|
Adverse Events
Age Group 6-11 Years - Dasiglucagon
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Age Group 6-11 Years - Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Age Group 6-11 Years - GlucaGen
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Age Group 12-17 Years - Dasiglucagon
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Age Group 12-17 Years - Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Age Group 12-17 Years - Glucagen
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Dasiglucagon 0.6 mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
GlucaGen® 1.0 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Age Group 6-11 Years - Dasiglucagon
n=8 participants at risk
Patients in the dasiglucagon group in the age group 6-11 years
|
Age Group 6-11 Years - Placebo
n=4 participants at risk
Patients in the placebo group in the age group 6-11 years
|
Age Group 6-11 Years - GlucaGen
n=4 participants at risk
Patients in the GlucaGen group in the age group 6-11 years
|
Age Group 12-17 Years - Dasiglucagon
n=12 participants at risk
Patients in the dasiglucagon group in the age group 12-17 years
|
Age Group 12-17 Years - Placebo
n=7 participants at risk
Patients in the placebo group in the age group 12-17 years
|
Age Group 12-17 Years - Glucagen
n=6 participants at risk
Patients in the GlucaGen group in the age group 12-17 years
|
Dasiglucagon 0.6 mg
n=20 participants at risk
Full population. Single fixed dose (subcutaneous injection) of dasiglucagon
|
Placebo
n=11 participants at risk
Full population. Single fixed dose (subcutaneous injection) of placebo
|
GlucaGen® 1.0 mg
n=10 participants at risk
Full population. Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight \<25 kg)
|
|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/12 • 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).
|
14.3%
1/7 • Number of events 1 • 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).
|
0.00%
0/6 • 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).
|
0.00%
0/20 • 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).
|
9.1%
1/11 • Number of events 1 • 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).
|
0.00%
0/10 • 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).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/4 • 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).
|
8.3%
1/12 • Number of events 1 • 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).
|
0.00%
0/7 • 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).
|
0.00%
0/6 • 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).
|
5.0%
1/20 • Number of events 1 • 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).
|
0.00%
0/11 • 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).
|
0.00%
0/10 • 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).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/12 • 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).
|
14.3%
1/7 • Number of events 1 • 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).
|
0.00%
0/6 • 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).
|
0.00%
0/20 • 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).
|
9.1%
1/11 • Number of events 1 • 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).
|
0.00%
0/10 • 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).
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • 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).
|
0.00%
0/4 • 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).
|
25.0%
1/4 • Number of events 1 • 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).
|
16.7%
2/12 • Number of events 2 • 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).
|
14.3%
1/7 • Number of events 1 • 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).
|
0.00%
0/6 • 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).
|
10.0%
2/20 • Number of events 2 • 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).
|
9.1%
1/11 • Number of events 1 • 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).
|
10.0%
1/10 • Number of events 1 • 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).
|
|
General disorders
Injection site erythema
|
0.00%
0/8 • 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).
|
0.00%
0/4 • 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).
|
50.0%
2/4 • Number of events 2 • 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).
|
0.00%
0/12 • 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).
|
0.00%
0/7 • 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).
|
16.7%
1/6 • Number of events 1 • 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).
|
0.00%
0/20 • 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).
|
0.00%
0/11 • 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).
|
30.0%
3/10 • Number of events 3 • 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).
|
|
General disorders
Injection site pain
|
0.00%
0/8 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/4 • 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).
|
8.3%
1/12 • Number of events 1 • 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).
|
0.00%
0/7 • 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).
|
16.7%
1/6 • Number of events 1 • 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).
|
5.0%
1/20 • Number of events 1 • 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).
|
0.00%
0/11 • 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).
|
10.0%
1/10 • Number of events 1 • 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).
|
|
General disorders
Injection site edema
|
0.00%
0/8 • 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).
|
0.00%
0/4 • 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).
|
25.0%
1/4 • Number of events 1 • 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).
|
0.00%
0/12 • 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).
|
0.00%
0/7 • 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).
|
0.00%
0/6 • 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).
|
0.00%
0/20 • 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).
|
0.00%
0/11 • 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).
|
10.0%
1/10 • Number of events 1 • 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).
|
|
General disorders
Injection site induration
|
0.00%
0/8 • 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).
|
0.00%
0/4 • 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).
|
25.0%
1/4 • Number of events 1 • 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).
|
0.00%
0/12 • 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).
|
0.00%
0/7 • 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).
|
0.00%
0/6 • 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).
|
0.00%
0/20 • 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).
|
0.00%
0/11 • 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).
|
10.0%
1/10 • Number of events 1 • 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).
|
|
General disorders
Infusion site bruising
|
0.00%
0/8 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/12 • 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).
|
14.3%
1/7 • Number of events 1 • 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).
|
0.00%
0/6 • 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).
|
0.00%
0/20 • 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).
|
9.1%
1/11 • Number of events 1 • 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).
|
0.00%
0/10 • 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).
|
|
General disorders
Infusion site pain
|
0.00%
0/8 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/12 • 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).
|
0.00%
0/7 • 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).
|
16.7%
1/6 • Number of events 1 • 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).
|
0.00%
0/20 • 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).
|
0.00%
0/11 • 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).
|
10.0%
1/10 • Number of events 1 • 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).
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 2 • 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).
|
0.00%
0/4 • 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).
|
50.0%
2/4 • Number of events 2 • 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).
|
91.7%
11/12 • Number of events 12 • 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).
|
0.00%
0/7 • 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).
|
16.7%
1/6 • Number of events 1 • 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).
|
65.0%
13/20 • Number of events 14 • 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).
|
0.00%
0/11 • 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).
|
30.0%
3/10 • Number of events 3 • 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).
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • Number of events 2 • 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).
|
0.00%
0/4 • 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).
|
25.0%
1/4 • Number of events 1 • 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).
|
66.7%
8/12 • Number of events 11 • 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).
|
0.00%
0/7 • 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).
|
0.00%
0/6 • 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).
|
50.0%
10/20 • Number of events 13 • 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).
|
0.00%
0/11 • 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).
|
10.0%
1/10 • Number of events 1 • 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).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/8 • 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).
|
25.0%
1/4 • Number of events 1 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/12 • 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).
|
0.00%
0/7 • 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).
|
0.00%
0/6 • 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).
|
0.00%
0/20 • 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).
|
9.1%
1/11 • Number of events 1 • 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).
|
0.00%
0/10 • 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).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/12 • 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).
|
0.00%
0/7 • 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).
|
16.7%
1/6 • Number of events 1 • 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).
|
0.00%
0/20 • 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).
|
0.00%
0/11 • 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).
|
10.0%
1/10 • Number of events 1 • 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).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
12.5%
1/8 • Number of events 1 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/4 • 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).
|
8.3%
1/12 • Number of events 1 • 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).
|
57.1%
4/7 • Number of events 16 • 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).
|
33.3%
2/6 • Number of events 2 • 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).
|
10.0%
2/20 • Number of events 2 • 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).
|
36.4%
4/11 • Number of events 16 • 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).
|
20.0%
2/10 • Number of events 2 • 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).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/4 • 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).
|
16.7%
2/12 • Number of events 3 • 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).
|
0.00%
0/7 • 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).
|
0.00%
0/6 • 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).
|
10.0%
2/20 • Number of events 3 • 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).
|
0.00%
0/11 • 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).
|
0.00%
0/10 • 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).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/12 • 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).
|
14.3%
1/7 • Number of events 1 • 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).
|
0.00%
0/6 • 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).
|
0.00%
0/20 • 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).
|
9.1%
1/11 • Number of events 1 • 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).
|
0.00%
0/10 • 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).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/4 • 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).
|
0.00%
0/12 • 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).
|
14.3%
1/7 • Number of events 1 • 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).
|
0.00%
0/6 • 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).
|
0.00%
0/20 • 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).
|
9.1%
1/11 • Number of events 1 • 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).
|
0.00%
0/10 • 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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place