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A phase 3, randomized, double-blind, placebo- and active-controlled, parallel-arm trial to assess the efficacy, safety, and pharmacokinetics of dasiglucagon relative to placebo and GlucaGen® when administered as a rescue therapy for severe hypoglycemia in children with type 1 diabetes mellitus (T1DM) treated with insulin
At least 40 children ≥6 years and <18 years of age with T1DM were planned to be randomized into the trial (2:1:1 for dasiglucagon:placebo:GlucaGen) and stratified by age intervals: 6 years to <12 years, and 12 years to <18 years; and by injection site (abdomen or thigh). A minimum of 16 patients were enrolled into each age group, including a minimum of 8 patients in each age group in the dasiglucagon treatment arm. In Germany only, a staggered approach was applied, whereby a positive safety assessment needed to be available for at least 10 patients in the age group of 12 years to <18 years who had completed the dosing visit in the overall trial before younger patients (6 to 11 years of age) were allowed to be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dasiglucagon | Experimental | Single fixed dose (s.c.injection) of dasiglucagon |
|
| placebo | Placebo Comparator | Single fixed dose (s.c.injection) of placebo |
|
| GlucaGen® | Active Comparator | Single fixed dose (s.c.injection) of GlucaGen® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dasiglucagon | Drug | glucagon analog |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Plasma Glucose Recovery | 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. | 0-45 minutes after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Glucose Recovery | 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. | 0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection |
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Inclusion Criteria:
Following receipt of verbal and written information about the trial, patient, parent(s) or guardian(s) of the patient must provide signed informed consent before any trial-related activity is carried out
Female or male patients with T1DM for at least 1 year, diagnostic criteria as defined by the American Diabetes Association; and receiving daily insulin
At least 6.0 years of age (inclusive) and less than 18.0 years
Body weight ≥20 kg
Female patients must meet one of the following criteria:
a. Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the trial from screening until last follow-up visit. An acceptable method of contraception includes at least one of the following: i. Abstinence from heterosexual intercourse ii. Systemic contraceptives (birth control pills, injectable/implant/ insertable hormonal birth control products, transdermal patch); if the participant is using systemic contraceptives, she must use an additional form of acceptable contraception (iii or iv, below) iii. Intrauterine device (with and without hormones) iv. Condom with spermicide or b. Participant is of non-childbearing potential due to pre-puberty status or a medical condition confirmed by the investigator
Male patients must meet the following criteria: If sexually active, uses condom and partner practices contraception during the trial from screening and until last follow-up visit
Willingness to adhere to the protocol requirements
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Exclusion Criteria:
1. Females who are pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or are lactating 2. Known or suspected allergy to trial product(s) or related products 3. History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema) 4. Previous randomization in this trial 5. History of an episode of severe hypoglycemia that required a third party assistance within a month prior to screening visit 6. History of hypoglycemic events associated with seizures or hypoglycemia unawareness in the last year prior to screening 7. History of epilepsy or seizure disorder 8. Receipt of any investigational drug within 3 months prior to screening 9. Active malignancy within the last 5 years 10. Congestive heart failure, New York Heart Association class II-IV 11. Current bleeding disorder, including anti-coagulant treatment 12. Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor) 13. Use of a daily systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this trial 14. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 × the upper limit of the normal range (ULN), bilirubin >1.5 × ULN, estimated glomerular filtration rate <30 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease study definition, or altered electrolyte values of clinical relevance for cardiac conduction, as judged by the investigator 15. Clinically significant abnormal electrocardiogram (ECG) at screening as judged by the investigator 16. Clinically significant illness within 4 weeks before screening, as judged by the investigator 17. Surgery or trauma with significant blood loss within the last 2 months prior to screening 18. Patients with mental incapacity or language barriers which preclude adequate understanding or cooperation, who are unwilling to participate in the trial, or who in the opinion of the investigator should not participate in the trial 19. Any condition interfering with trial participation or evaluation or that could be hazardous to the patient 20. The use of prescription or non-prescription medications known to cause QT prolongation
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| Name | Affiliation | Role |
|---|---|---|
| Christina M Sylvest, MSc Pharm | Zealand Pharma A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute, Inc | Escondido | California | 92025 | United States | ||
| Yale University School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dasiglucagon 0.6 mg | Single fixed dose (subcutaneous injection) of dasiglucagon dasiglucagon: glucagon analog |
| FG001 | Placebo | Single fixed dose (subcutaneous injection) of placebo placebo: placebo for dasiglucagon |
| FG002 | GlucaGen® 1.0 mg | Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg) GlucaGen HypoKit: native glucagon |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set of all randomized and treated participants. Treatment assignment was based on the treatment actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dasiglucagon 0.6 mg | Single fixed dose (subcutaneous injection) of dasiglucagon dasiglucagon: glucagon analog |
| BG001 | Placebo | Single fixed dose (subcutaneous injection) of placebo placebo: placebo for dasiglucagon |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Plasma Glucose Recovery | 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. | 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. | Posted | Median | 95% Confidence Interval | minutes | 0-45 minutes after dosing |
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Age Group 6-11 Years - Dasiglucagon | Patients in the dasiglucagon group in the age group 6-11 years |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Kim Mark Knudsen | Zealand Pharma A/S | +4550603780 | KMKnudsen@zealandpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 8, 2019 | Mar 26, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 16, 2019 | Mar 26, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000710373 | dasiglucagon |
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| placebo | Drug | placebo for dasiglucagon |
|
|
| GlucaGen HypoKit | Drug | native glucagon |
|
| Plasma Glucose Changes From Baseline | 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 | 0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection |
| Pharmacodynamics - Area Under the Effect Curve (0-30 Minutes) | 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. | 0-30 minutes |
| Administration of Rescue IV Glucose Infusion After IMP Injection | Number of patients receiving IV rescue glucose administration for hypoglycemia after administration of IMP. IV = intravenous. IMP = investigational medicinal product. | 0-45 minutes |
| Time to First IV Glucose Infusion After IMP Administration | Time to first IV rescue glucose administration for hypoglycemia after administration of IMP. IV = intravenous. IMP = investigational medicinal product. | 0-45 minutes |
| Pharmacokinetics: AUC0-30 Min | 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. | 0-30 minutes |
| Pharmacokinetics: AUC0-300min | 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. | 0-300 minutes |
| Pharmacokinetics: AUC0-inf | 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. | 0-300 minutes |
| Pharmacokinetics: Cmax | 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. | 0-300 minutes |
| Pharmacokinetics: Tmax | 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. | 0-300 minutes |
| Pharmacokinetics: λz | 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. | 0-300 minutes |
| Pharmacokinetics: t½ | 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. | 0-300 minutes |
| Pharmacokinetics: CL/f | 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. | 0-300 minutes |
| Pharmacokinetics: Vz/f | 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. | 0-300 minutes |
| Pharmacokinetics: MRT | 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. | 0-300 minutes |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Indiana University, Department of Pediatrics | Indianapolis | Indiana | 46202 | United States |
| Auf der Bult - Diabetes Center for Children | Hanover | 30173 | Germany |
| University Medical Center Ljubljana, Children's Hospital, Department for Endocrinology, Diabetes and Metabolism | Ljubljana | 1000 | Slovenia |
| BG002 | GlucaGen® 1.0 mg | Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg) GlucaGen HypoKit: native glucagon |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body weight | Mean | Standard Deviation | kg |
|
| Body mass index | Mean | Standard Deviation | kg per square meter |
|
| Dasiglucagon 0.6 mg |
Single fixed dose (subcutaneous injection) of dasiglucagon dasiglucagon: glucagon analog |
| OG001 | Placebo | Single fixed dose (subcutaneous injection) of placebo placebo: placebo for dasiglucagon |
| OG002 | GlucaGen® 1.0 mg | Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg) GlucaGen HypoKit: native glucagon |
|
|
|
| Secondary | Plasma Glucose Recovery | 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. | 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. | Posted | Count of Participants | Participants | 0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection |
|
|
|
|
| Secondary | Plasma Glucose Changes From Baseline | 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 | 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. | Posted | Mean | Standard Deviation | mg/dL | 0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection |
|
|
|
|
| Secondary | Pharmacodynamics - Area Under the Effect Curve (0-30 Minutes) | 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. | 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. | Posted | Mean | Standard Deviation | mmol*h/L | 0-30 minutes |
|
|
|
| Secondary | Administration of Rescue IV Glucose Infusion After IMP Injection | Number of patients receiving IV rescue glucose administration for hypoglycemia after administration of IMP. IV = intravenous. IMP = investigational medicinal product. | Safety analysis set (same as the full analysis set) of all randomized and treated patients. | Posted | Count of Participants | Participants | 0-45 minutes |
|
|
|
| Secondary | Time to First IV Glucose Infusion After IMP Administration | Time to first IV rescue glucose administration for hypoglycemia after administration of IMP. IV = intravenous. IMP = investigational medicinal product. | Only the patient who received IV glucose administration is included. | Posted | Number | minutes | 0-45 minutes |
|
|
|
| Secondary | Pharmacokinetics: AUC0-30 Min | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pmol/L | 0-30 minutes |
|
|
|
| Secondary | Pharmacokinetics: AUC0-300min | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pmol/L | 0-300 minutes |
|
|
|
| Secondary | Pharmacokinetics: AUC0-inf | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pmol/L | 0-300 minutes |
|
|
|
| Secondary | Pharmacokinetics: Cmax | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | pmol/L | 0-300 minutes |
|
|
|
| Secondary | Pharmacokinetics: Tmax | 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. | 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. | Posted | Median | Full Range | hours | 0-300 minutes |
|
|
|
| Secondary | Pharmacokinetics: λz | 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. | 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. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | 1/hour | 0-300 minutes |
|
|
|
| Secondary | Pharmacokinetics: t½ | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | 0-300 minutes |
|
|
|
| Secondary | Pharmacokinetics: CL/f | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | 0-300 minutes |
|
|
|
| Secondary | Pharmacokinetics: Vz/f | 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. | 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. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | litres | 0-300 minutes |
|
|
|
| Secondary | Pharmacokinetics: MRT | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | 0-300 minutes |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | Age Group 6-11 Years - Placebo | Patients in the placebo group in the age group 6-11 years | 0 | 4 | 0 | 4 | 1 | 4 |
| EG002 | Age Group 6-11 Years - GlucaGen | Patients in the GlucaGen group in the age group 6-11 years | 0 | 4 | 0 | 4 | 4 | 4 |
| EG003 | Age Group 12-17 Years - Dasiglucagon | Patients in the dasiglucagon group in the age group 12-17 years | 0 | 12 | 0 | 12 | 12 | 12 |
| EG004 | Age Group 12-17 Years - Placebo | Patients in the placebo group in the age group 12-17 years | 0 | 7 | 0 | 7 | 6 | 7 |
| EG005 | Age Group 12-17 Years - Glucagen | Patients in the GlucaGen group in the age group 12-17 years | 0 | 6 | 0 | 6 | 5 | 6 |
| EG006 | Dasiglucagon 0.6 mg | Full population. Single fixed dose (subcutaneous injection) of dasiglucagon | 0 | 20 | 0 | 20 | 15 | 20 |
| EG007 | Placebo | Full population. Single fixed dose (subcutaneous injection) of placebo | 0 | 11 | 0 | 11 | 7 | 11 |
| EG008 | GlucaGen® 1.0 mg | Full population. Single fixed dose (subcutaneous injection) of GlucaGen® (0.5 mg if body weight <25 kg) | 0 | 10 | 0 | 10 | 9 | 10 |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Injection site edema | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Infusion site bruising | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
Not provided
Not provided
|
| Glucose recovery at 15 minutes |
|
| Glucose recovery at 10 minutes |
|
|
| At 15 minutes |
|
| At 10 minutes |
|