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The objective of the trial is to evaluate the efficacy and safety of dasiglucagon administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care + dasiglucagon | Experimental | 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care |
|
| Standard of Care Only | Other | 4 weeks (Treatment Period 1) of standard of care only + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasiglucagon | Drug | Glucagon analog |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia Episode Rate | Hypoglycemia episode rate, defined as average weekly number of hypoglycemic episodes (PG <70 mg/dL [3.9 mmol/L]) during Weeks 2-4 as detected by self-monitored plasma glucose (SMPG). The Week 2-4 value is the average weekly number of hypoglycemic episodes across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the average weekly number of hypoglycemic episodes during the 2-week baseline period. | Baseline, Week 2-4 (Treatment Period 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in Fasting Tolerance | Increase in fasting tolerance (time from beginning of meal to the beginning of the first continuous 15-minute continuous glucose monitoring reading <70 mg/dL [3.9 mmol/L]), or the time the test ended if a continuous 15-minute CGM reading <70 mg/dL was not reached. The change from Baseline to the End of Treatment Period 1 (Week 4) is also provided. The Baseline value is the value recorded at the Screening visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charlotte Teglman Schioeler | Zealand Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Colorado | Aurora | Colorado | 13123 | United States | ||
| Children's Hospital of Philadelphia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care + Dasiglucagon (Treatment Period 1) | 4 weeks (Treatment Period 1) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country |
| FG001 | Standard of Care Only (Treatment Period 1) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
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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 | Nov 12, 2020 | Aug 31, 2023 |
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| Standard of Care | Other | Standard of care according to site and/or country |
|
| Baseline, Week 2-4 (Treatment Period 1) |
| Percent Time in Range 70-180 mg/dL | Percent time in range 70-180 mg/dL (3.9-10.0 mmol/L) during Weeks 2-4 as measured by continuous glucose monitoring. The Week 2-4 value is the average weekly percent time in range 70-180 mg/dL across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value was calculated as the average percent time in range during the 14 days before randomization. | Baseline, Week 2-4 (Treatment Period 1) |
| Clinically Significant Hypoglycemia Episode Rates | Clinically significant hypoglycemia episode rates during Weeks 2-4, defined as average weekly number of clinically significant hypoglycemic episodes (PG <54 mg/dL [3.0 mmol/L]), as detected by SMPG. The Week 2-4 value is the average weekly clinically significant hypoglycemia episode rate across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the average weekly number of clinically significant hypoglycemic episodes during the 2-week baseline period. | Baseline, Week 2-4 (Treatment Period 1) |
| Total Amount of Gastric Carbohydrates Administered to Treat Hypoglycemia | Total amount of gastric carbohydrates administered via nasogastric tube or gastrostomy per week to treat hypoglycemia. The Week 2-4 value is the average weekly total amount of gastric carbohydrates across the last 3 weeks of treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value recorded during the 2-week Baseline period. | Baseline, Week 2-4 (Treatment Period 1) |
| Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia | Rate of gastric carbohydrate administrations via nasogastric tube or gastrostomy per week to treat hypoglycemia, calculated as the number of times gastric carbohydrates were administered to treat hypoglycemia per week. The Week 2-4 value is the average weekly rate of gastric carbohydrate administrations across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value recorded during the 2-week Baseline period. | Baseline, Week 2-4 (Treatment Period 1) |
| Extent of Hypoglycemia | Extent of hypoglycemia (area over the glucose curve [AOCglucose] below 70 mg/dL [3.9 mmol/L]) and below 54 mg/dL [3.0 mmol/L] as measured by continuous glucose monitoring. The extent of hypoglycemia was defined as the AOCglucose under the threshold divided by total duration in hours of CGM measurement. A reduction in this measure indicates a benefit. The Week 2-4 value is the average weekly extent of hypoglycemia below 70 mg/dL and below 54 mg/dL across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value assessed during the 14 days before randomization. | Baseline, Week 2-4 (Treatment Period 1) |
| Amount of Nightly Gastric Carbohydrates Administered | Amount of nightly (midnight to 6 am) gastric carbohydrates administered via nasogastric tube or gastrostomy per week. The change from Baseline is also provided for each week. The Baseline value is the value recorded during the 2-week Baseline period. | Baseline, Week 2-4 (Treatment Period 1) |
| Total Amount of Gastric Carbohydrates Administered | Total amount of gastric carbohydrates administered (regardless of whether this was to treat hypoglycemia or not) via nasogastric tube or gastrostomy per week. The Week 2-4 value is the average amount of gastric carbohydrates administered via nasogastric tube or gastrostomy across the last 3 weeks of the treatment period. The change from baseline to Week 2-4 is also provided. The baseline value is the value recorded during the 2-week baseline period. | Baseline, Week 2-4 (Treatment Period 1) |
| Percent Time in Hypoglycemia | Percent time in hypoglycemia (PG <70 mg/dL [3.9 mmol/L]) as measured by continuous glucose monitoring. The Week 2-4 value is the average weekly percent of time in hypoglycemia across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value assessed during the 14 days before randomization. | Baseline, Week 2-4 (Treatment Period 1) |
| Rate of Hypoglycemic Episodes | Rate of hypoglycemic episodes, defined as number of episodes with PG <70 mg/dL (3.9 mmol/L) for 15 minutes or more per week, as measured by continuous glucose monitoring. The Week 2-4 value is the average weekly number of hypoglycemic episodes across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the average weekly number of hypoglycemic episodes during the 14 days before randomization. | Baseline, Week 2-4 (Treatment Period 1) |
| Percent Time in Hypoglycemia in Treatment Period 2 | Percent time in hypoglycemia (PG <70 mg/dL [3.9 mmol/L]) as measured by continuous glucose monitoring. The Week 6-8 value is the average weekly percent of time in hypoglycemia across the last 3 weeks of the treatment period. The change from Baseline to Week 6-8 is also provided. The Baseline value is the value assessed during the 14 days before randomization. | Baseline, Week 6-8 (Treatment Period 2) |
| Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia in Treatment Period 2 | Rate of gastric carbohydrate administrations via nasogastric tube or gastrostomy per week to treat hypoglycemia, calculated as the number of times gastric carbohydrates were administered to treat hypoglycemia per week. The Week 6-8 value is the average weekly rate of gastric carbohydrate administrations across the last 3 weeks of the treatment period. The change from Baseline to Week 6-8 is also provided. The Baseline value is the value recorded during the 2-week Baseline period. | Baseline, Week 6-8 (Treatment Period 2) |
| Rate of Hypoglycemic Episodes in Treatment Period 2 | Hypoglycemia episode rate, defined as average weekly number of hypoglycemic episodes (PG <70 mg/dL [3.9 mmol/L]) as detected by SMPG. The Week 6-8 value is the average weekly number of hypoglycemic episodes across the last 3 weeks of the treatment period. The change from Baseline to Week 6-8 is also provided. The Baseline value is the average weekly number of hypoglycemic episodes during the 2-week baseline period. | Baseline, Week 6-8 (Treatment Period 2) |
| Rate of Clinically Significant Hypoglycemia Episodes in Treatment Period 2 | Change from Baseline to Week 6-8 in the clinically significant (CS) hypoglycemia episode rate in treatment period 2, defined as the average weekly number of episodes <54 mg/dL (3.0 mmol/L), for 15 minutes or more, as measured by continuous glucose monitoring (CGM). The Week 6-8 value is the average weekly CS hypoglycemia episode rate across the last 3 weeks of the treatment period. The Baseline value is the average weekly number of CS hypoglycemic episodes during the 14 days before randomization. | Baseline, Week 6-8 (Treatment Period 2) |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| University Hospital Düsseldorf, Department of Pediatrics | Düsseldorf | 40225 | Germany |
| Otto von Guericke University Magdeburg, Department of Pediatrics | Magdeburg | 39120 | Germany |
| Hadassah Medical Center | Jerusalem | 9765422 | Israel |
| NHS Greater Glasgow and Clyde | Glasgow | United Kingdom |
| Alder Hey Children'sHospital NHS Foundation Trust | Liverpool | United Kingdom |
| Great Osmond Street Hospital for Children NHS Foundation Trust | London | United Kingdom |
| Central Manchester University Hospital NHS Foundation Trust | Manchester | United Kingdom |
4 weeks (Treatment Period 1) of standard of care only Standard of care: Standard of care according to site and/or country |
| FG002 | Standard of Care + Dasiglucagon (Treatment Period 2) | 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country |
| COMPLETED |
|
| NOT COMPLETED |
|
| Treatment Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care + Dasiglucagon | 4 weeks (Treatment Period 1) + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country |
| BG001 | Standard of Care Only | 4 weeks (Treatment Period 1) of standard of care + 4 weeks (Treatment Period 2) of dasiglucagon treatment as an SC infusion starting at 10 µg/hr on top of standard of care Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Gastrostomy/nasogastric tube | Count of Participants | Participants |
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| 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 | Hypoglycemia Episode Rate | Hypoglycemia episode rate, defined as average weekly number of hypoglycemic episodes (PG <70 mg/dL [3.9 mmol/L]) during Weeks 2-4 as detected by self-monitored plasma glucose (SMPG). The Week 2-4 value is the average weekly number of hypoglycemic episodes across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the average weekly number of hypoglycemic episodes during the 2-week baseline period. | Posted | Mean | Standard Deviation | episodes per week | Baseline, Week 2-4 (Treatment Period 1) |
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| Secondary | Increase in Fasting Tolerance | Increase in fasting tolerance (time from beginning of meal to the beginning of the first continuous 15-minute continuous glucose monitoring reading <70 mg/dL [3.9 mmol/L]), or the time the test ended if a continuous 15-minute CGM reading <70 mg/dL was not reached. The change from Baseline to the End of Treatment Period 1 (Week 4) is also provided. The Baseline value is the value recorded at the Screening visit. | There were 2 missing values at the end of Treatment Period 1 in the dasiglucagon + standard of care group. | Posted | Mean | Standard Deviation | hours | Baseline, Week 2-4 (Treatment Period 1) |
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| Secondary | Percent Time in Range 70-180 mg/dL | Percent time in range 70-180 mg/dL (3.9-10.0 mmol/L) during Weeks 2-4 as measured by continuous glucose monitoring. The Week 2-4 value is the average weekly percent time in range 70-180 mg/dL across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value was calculated as the average percent time in range during the 14 days before randomization. | There was 1 missing value at Baseline for the dasiglucagon + standard of care group. | Posted | Mean | Standard Deviation | percent time | Baseline, Week 2-4 (Treatment Period 1) |
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| Secondary | Clinically Significant Hypoglycemia Episode Rates | Clinically significant hypoglycemia episode rates during Weeks 2-4, defined as average weekly number of clinically significant hypoglycemic episodes (PG <54 mg/dL [3.0 mmol/L]), as detected by SMPG. The Week 2-4 value is the average weekly clinically significant hypoglycemia episode rate across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the average weekly number of clinically significant hypoglycemic episodes during the 2-week baseline period. | Posted | Mean | Standard Deviation | episodes per week | Baseline, Week 2-4 (Treatment Period 1) |
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| Secondary | Total Amount of Gastric Carbohydrates Administered to Treat Hypoglycemia | Total amount of gastric carbohydrates administered via nasogastric tube or gastrostomy per week to treat hypoglycemia. The Week 2-4 value is the average weekly total amount of gastric carbohydrates across the last 3 weeks of treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value recorded during the 2-week Baseline period. | The total amount of gastric carbohydrates administered to treat hypoglycemia could be evaluated only in patients with gastrostomy or NG-tube at screening, and is summarized accordingly. | Posted | Mean | Standard Deviation | grams | Baseline, Week 2-4 (Treatment Period 1) |
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| Secondary | Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia | Rate of gastric carbohydrate administrations via nasogastric tube or gastrostomy per week to treat hypoglycemia, calculated as the number of times gastric carbohydrates were administered to treat hypoglycemia per week. The Week 2-4 value is the average weekly rate of gastric carbohydrate administrations across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value recorded during the 2-week Baseline period. | The total amount of gastric carbohydrates administered to treat hypoglycemia could be evaluated only in patients with gastrostomy or NG-tube at screening, and is summarized accordingly. | Posted | Mean | Standard Deviation | number of administrations per week | Baseline, Week 2-4 (Treatment Period 1) |
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| Secondary | Extent of Hypoglycemia | Extent of hypoglycemia (area over the glucose curve [AOCglucose] below 70 mg/dL [3.9 mmol/L]) and below 54 mg/dL [3.0 mmol/L] as measured by continuous glucose monitoring. The extent of hypoglycemia was defined as the AOCglucose under the threshold divided by total duration in hours of CGM measurement. A reduction in this measure indicates a benefit. The Week 2-4 value is the average weekly extent of hypoglycemia below 70 mg/dL and below 54 mg/dL across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value assessed during the 14 days before randomization. | There was 1 missing value at Baseline for the dasiglucagon + standard of care group. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 2-4 (Treatment Period 1) |
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| Secondary | Amount of Nightly Gastric Carbohydrates Administered | Amount of nightly (midnight to 6 am) gastric carbohydrates administered via nasogastric tube or gastrostomy per week. The change from Baseline is also provided for each week. The Baseline value is the value recorded during the 2-week Baseline period. | The total amount of gastric carbohydrates administered to treat hypoglycemia could be evaluated only in patients with gastrostomy or NG-tube at screening, and is summarized accordingly. | Posted | Mean | Standard Deviation | grams | Baseline, Week 2-4 (Treatment Period 1) |
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| Secondary | Total Amount of Gastric Carbohydrates Administered | Total amount of gastric carbohydrates administered (regardless of whether this was to treat hypoglycemia or not) via nasogastric tube or gastrostomy per week. The Week 2-4 value is the average amount of gastric carbohydrates administered via nasogastric tube or gastrostomy across the last 3 weeks of the treatment period. The change from baseline to Week 2-4 is also provided. The baseline value is the value recorded during the 2-week baseline period. | The total amount of gastric carbohydrates administered to treat hypoglycemia could be evaluated only in patients with gastrostomy or NG-tube at screening, and is summarized accordingly. | Posted | Mean | Standard Deviation | grams | Baseline, Week 2-4 (Treatment Period 1) |
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| Secondary | Percent Time in Hypoglycemia | Percent time in hypoglycemia (PG <70 mg/dL [3.9 mmol/L]) as measured by continuous glucose monitoring. The Week 2-4 value is the average weekly percent of time in hypoglycemia across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the value assessed during the 14 days before randomization. | There was 1 missing value at Baseline for the dasiglucagon + standard of care group. | Posted | Mean | Standard Deviation | percent time | Baseline, Week 2-4 (Treatment Period 1) |
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| Secondary | Rate of Hypoglycemic Episodes | Rate of hypoglycemic episodes, defined as number of episodes with PG <70 mg/dL (3.9 mmol/L) for 15 minutes or more per week, as measured by continuous glucose monitoring. The Week 2-4 value is the average weekly number of hypoglycemic episodes across the last 3 weeks of the treatment period. The change from Baseline to Week 2-4 is also provided. The Baseline value is the average weekly number of hypoglycemic episodes during the 14 days before randomization. | There was 1 missing value at Baseline for the dasiglucagon + standard of care group. | Posted | Mean | Standard Deviation | episodes per week | Baseline, Week 2-4 (Treatment Period 1) |
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| Secondary | Percent Time in Hypoglycemia in Treatment Period 2 | Percent time in hypoglycemia (PG <70 mg/dL [3.9 mmol/L]) as measured by continuous glucose monitoring. The Week 6-8 value is the average weekly percent of time in hypoglycemia across the last 3 weeks of the treatment period. The change from Baseline to Week 6-8 is also provided. The Baseline value is the value assessed during the 14 days before randomization. | There was 1 participant with a missing value at Baseline. | Posted | Mean | Standard Deviation | percent time | Baseline, Week 6-8 (Treatment Period 2) |
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| Secondary | Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia in Treatment Period 2 | Rate of gastric carbohydrate administrations via nasogastric tube or gastrostomy per week to treat hypoglycemia, calculated as the number of times gastric carbohydrates were administered to treat hypoglycemia per week. The Week 6-8 value is the average weekly rate of gastric carbohydrate administrations across the last 3 weeks of the treatment period. The change from Baseline to Week 6-8 is also provided. The Baseline value is the value recorded during the 2-week Baseline period. | The total amount of gastric carbohydrates administered to treat hypoglycemia could be evaluated only in patients with gastrostomy or NG-tube at screening, and is summarized accordingly. | Posted | Mean | Standard Deviation | number of administrations per week | Baseline, Week 6-8 (Treatment Period 2) |
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| Secondary | Rate of Hypoglycemic Episodes in Treatment Period 2 | Hypoglycemia episode rate, defined as average weekly number of hypoglycemic episodes (PG <70 mg/dL [3.9 mmol/L]) as detected by SMPG. The Week 6-8 value is the average weekly number of hypoglycemic episodes across the last 3 weeks of the treatment period. The change from Baseline to Week 6-8 is also provided. The Baseline value is the average weekly number of hypoglycemic episodes during the 2-week baseline period. | Posted | Mean | Standard Deviation | episodes per week | Baseline, Week 6-8 (Treatment Period 2) |
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| Secondary | Rate of Clinically Significant Hypoglycemia Episodes in Treatment Period 2 | Change from Baseline to Week 6-8 in the clinically significant (CS) hypoglycemia episode rate in treatment period 2, defined as the average weekly number of episodes <54 mg/dL (3.0 mmol/L), for 15 minutes or more, as measured by continuous glucose monitoring (CGM). The Week 6-8 value is the average weekly CS hypoglycemia episode rate across the last 3 weeks of the treatment period. The Baseline value is the average weekly number of CS hypoglycemic episodes during the 14 days before randomization. | There was 1 participant with a missing value at Baseline. | Posted | Mean | Standard Deviation | episodes per week | Baseline, Week 6-8 (Treatment Period 2) |
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Adverse event data were recorded from the time a signed and dated informed consent form was obtained until the end of the posttreatment follow-up period or inclusion in the ZP4207-17106 extension trial (up to 16 weeks, from Day -28 through Week 12).
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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 | Treatment Period 1: Standard of Care + Dasiglucagon | All participants treated with standard of care + dasiglucagon during Treatment Period 1 (Weeks 1 to 4) Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country | 0 | 16 | 2 | 16 | 14 | 16 |
| EG001 | Treatment Period 1: Standard of Care Only | All participants treated with standard of care only during Treatment Period 1 (Weeks 1 to 4) Standard of Care: Standard of care according to site and/or country | 0 | 16 | 1 | 16 | 8 | 16 |
| EG002 | Treatment Period 2: Standard of Care + Dasiglucagon | All participants treated with standard of care + dasiglucagon during Treatment Period 2 (Weeks 5 to 8) Dasiglucagon: Glucagon analog Standard of care: Standard of care according to site and/or country | 0 | 32 | 2 | 32 | 24 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Localised Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Vascular Device Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| H1N1 Influenza | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Localised Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Candida Nappy Rash | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Ear Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Gastritis Viral | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Herpangina | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Hand-Foot-And-Mouth Disease | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Eczema Infected | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Periorbital Cellulitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Pharyngitis Streptococcal | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Respiratory Syncytial Virus Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Dermatitis Diaper | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Necrolytic Migratory Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Pruritus Generalised | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Skin Discolouration | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Teething | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Post-Tussive Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Retching | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Drooling | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Loss Of Consciousness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Medical Device Site Irritation | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Catheter Site Haemorrhage | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Developmental Delay | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Infusion Site Bruising | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Blood Iron Decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Glycosylated Haemoglobin Increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Eye Movement Disorder | Eye disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ketosis | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Increased Appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Respiratory Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Otorrhoea | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Stoma Site Hypergranulation | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Muscle Twitching | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Aortic Dilatation | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sune Birch | Zealand Pharma | +45 5060 3864 | SBirch@zealandpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 13, 2020 | Aug 31, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D044903 | Congenital Hyperinsulinism |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007003 | Hypoglycemia |
Not provided
Not provided
| ID | Term |
|---|---|
| C000710373 | dasiglucagon |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| United Kingdom |
|
| Israel |
|
| Germany |
|
| Nasogastric tube |
|
| None |
|
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