Primary outcomeMean· Hours 36-48 after initiation of trial drug (Part 1)
Mean Intravenous Glucose Infusion Rate
| Group | Value (mg/kg/minute) | Spread |
|---|---|---|
| Dasiglucagon | 4.33 | 4.922 |
| Placebo | 9.51 | 5.655 |
Trial · Interventional
CompletedPhase 2/3Results postedRegistry dataTrial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
NCTNCT04172441 (opens ClinicalTrials.gov in a new tab)Other idZP4207-17103Other id2017-004545-24Other id2017
Overview
- Status
- Completed
- Phase
- Phase 2/3
- Enrollment
- 12 participants (actual)
- Sponsor
- Zealand Pharma · Industry
- Design
- Randomized · Quadruple masking
- Countries
4 countries
United States, Germany, Israel, United Kingdom
- Start
- 19 Jun 2020
- Primary completion
- 17 Feb 2022
- Completion
- 7 Mar 2022
- First posted
- 21 Nov 2019
- Last update posted
- 14 Mar 2025
- Conditions
- Congenital Hyperinsulinism
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2020202120222023
- Ph 2/3
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
NCT0417244119 Jun 2020 to 7 Mar 2022
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to prevent/manage hypoglycemia.
Interventions
- dasiglucagonDrug
- PlaceboDrug
Arms2
Experimental
dasiglucagon first then placebo
48 hours of dasiglucagon subcutaneous (sc) infusion starting at 10 µg/hour with crossover to 48 hours placebo sc infusion (part 1) followed by 21 days of dasiglucagon sc infusion (part 2).
Experimental
placebo first then dasiglucagon
48 hours of placebo sc infusion with crossover to 48 hours dasiglucagon sc infusion starting at 10 µg/hour (part 1) followed by 21 days of dasiglucagon sc infusion (part 2).
Primary outcomes1
Outcomes the sponsor listed as primary.
Mean Intravenous Glucose Infusion Rate
Time frame · Hours 36-48 after initiation of trial drug (Part 1)
Registry description
Mean intravenous (IV) glucose infusion rate (GIR) in the last 12 hours of each treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration).
Secondary outcomes(20)
Carbohydrates Administered
Time frame · 0 to 48 hours after initiation of trial drug
Registry description
Total amount (g) of carbohydrates administered during the crossover part of the trial (dasiglucagon or placebo administration) per day.
Mean Intravenous Glucose Infusion Rate
Time frame · 48 hours after initiation of trial drug (Part 1)
Registry description
Mean IV GIR for each 48-hour treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration).
Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute
Time frame · Hours 36-48 after initiation of trial drug (Part 1)
Registry description
Mean IV GIR below 10 mg/kg/minute in the last 12 hours of each treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration) (yes/no)
Time to Complete Weaning Off Intravenous Glucose
Time frame · Days 5 to 25 (Part 2)
Registry description
Time in days to complete weaning off IV glucose administration during Part 2, defined as the first point in time when the patient had been off IV glucose administration for at least 12 hours.
Hypoglycemia Event Rate in Part 2
Time frame · Days 5 to 25
Registry description
Hypoglycemia event rate, defined as number of hypoglycemic events when PG was \<70 mg/dL (or 3.9 mmol/L), as detected by self-monitored plasma glucose.
Clinically Significant Hypoglycemia Events in Part 2
Time frame · Days 5 to 25
Registry description
Clinically significant hypoglycemia event rate, defined as number of events when PG was \<54 mg/dL (3.0 mmol/L), as detected by self-monitored plasma glucose.
Time to Actual Hospital Discharge
Time frame · Days 5 to 25
Registry description
Time in days to actual hospital discharge defined as the time from first exposure to the study drug in Part 2 to discharge from hospital.
Time to Pancreatic Surgery
Time frame · Days 5 to 25
Registry description
Time (days) to pancreatic surgery (sub-total or total pancreatectomy with a cutoff of ≥95%).
Carbohydrates Administered
Time frame · Days 5 to 25
Registry description
Total amount (g) of carbohydrates administered (regardless of the route) per day.
Carbohydrates Administered Intravenously
Time frame · Days 5 to 25
Registry description
Amount (g) of carbohydrates administered via IV glucose infusion or bolus or total parenteral nutrition. This secondary endpoint was intended to account only for carbohydrates administered via IV glucose infusion or bolus. It was not possible to differentiate between carbohydrates administered via IV glucose infusion or bolus and carbohydrates administered as being, or not being, part of total parenteral nutrition from the collected data. This endpoint was expanded to include both.
Carbohydrates Administered Parenterally
Time frame · Days 5 to 25
Registry description
Amount (g) of carbohydrates administered as part of total parenteral nutrition.
Carbohydrates Administered Orally
Time frame · Days 5 to 25
Registry description
Amount (g) of carbohydrates administered via oral route.
Carbohydrates Administered Via Gastric Feed
Time frame · Days 5 to 25
Registry description
Amount (g) of carbohydrates administered via nasogastric tube or gastrostomy.
Time in Range in Part 2
Time frame · Days 5 to 25
Registry description
Percent time in range (PG between 70 to 180 mg/dL \[3.9-10.0 mmol/L\]) as measured by continuous glucose monitoring.
Time in Hypoglycemia in Part 2
Time frame · Days 5 to 25
Registry description
Percent time in hypoglycemia (when PG was \<70 mg/dL \[or 3.9 mmol/L\]) as measured by continuous glucose monitoring.
Time in Clinically Significant Hypoglycemia in Part 2
Time frame · Days 5 to 25
Registry description
Percent time in clinically significant hypoglycemia (when PG was \<54 mg/dL \[or 3.0 mmol/L\]) as measured by continuous glucose monitoring.
Hypoglycemia Episodes in Part 2
Time frame · Days 5 to 25
Registry description
Rate of hypoglycemia episodes, defined as number of episodes per week when PG was \<70 mg/dL (3.9 mmol/L) for 15 minutes or more, as measured by continuous glucose monitoring.
Clinically Significant Hypoglycemia Episodes in Part 2
Time frame · Days 5 to 25
Registry description
Rate of clinically significant hypoglycemia episodes, defined as number of episodes per week when was \<54 mg/dL (3.0 mmol/L) for 15 minutes or more, as measured by continuous glucose monitoring.
Extent of Hypoglycemia in Part 2
Time frame · Days 5 to 25
Registry description
Extent of hypoglycemia (defined as the area over the glucose curve \[AOCglucose\] below 70 mg/dL \[3.9 mmol/L\]) as measured by continuous glucose monitoring.
Extent of Clinically Significant Hypoglycemia in Part 2
Time frame · Days 5 to 25
Registry description
Extent of clinically significant hypoglycemia (defined as the area over the glucose curve \[AOCglucose\] below 54 mg/dL \[3.0 mmol/L\]) as measured by continuous glucose monitoring, divided by the total duration in hours of continuous glucose monitoring.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· 0 to 48 hours after initiation of trial drug
Carbohydrates Administered
| Group | Value (g/day) | Spread |
|---|---|---|
| Dasiglucagon | 106.7 | 53.72 |
| Placebo | 139.1 | 57.35 |
Secondary outcomeMean· 48 hours after initiation of trial drug (Part 1)
Mean Intravenous Glucose Infusion Rate
| Group | Value (mg/kg/minute) | Spread |
|---|---|---|
| Dasiglucagon | 6.9 | 5.91 |
| Placebo | 10.4 | 5.31 |
Secondary outcomeCount of participants· Hours 36-48 after initiation of trial drug (Part 1)
Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute
| Group | Value (Participants) |
|---|---|
| Dasiglucagon | 9 |
| Placebo | 6 |
Secondary outcomeMedian· Days 5 to 25 (Part 2)
Time to Complete Weaning Off Intravenous Glucose
| Group | Value (days) |
|---|---|
| Dasiglucagon (Part 2) | 5.8 |
Secondary outcomeMedian· Days 5 to 25
Hypoglycemia Event Rate in Part 2
| Group | Value (episodes per week) |
|---|---|
| Dasiglucagon (Part 2) | 8.50 |
Secondary outcomeMedian· Days 5 to 25
Clinically Significant Hypoglycemia Events in Part 2
| Group | Value (episodes per week) |
|---|---|
| Dasiglucagon (Part 2) | 1.67 |
Secondary outcomeMedian· Days 5 to 25
Time to Actual Hospital Discharge
| Group | Value (days) |
|---|---|
| Dasiglucagon (Part 2) | NA |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Part 1: DasiglucagonAdverse events during administration of dasiglucagon during Part 1 of the study. | 0 / 12 | 0 / 12 | 3 / 12 |
| Part 1: PlaceboAdverse events during administration of placebo during Part 1 of the study. | 0 / 12 | 0 / 12 | 7 / 12 |
| Part 2: DasiglucagonAdverse events during administration of dasiglucagon during Part 2 of the study. | 0 / 12 | 1 / 12 | 10 / 12 |
| Parts 1 and 2: DasiglucagonAdverse events during administration of dasiglucagon during Parts 1 and 2 of the study. | 0 / 12 | 1 / 12 | 10 / 12 |
| Follow-up PeriodAdverse events occurring during the Follow-up Period. | 0 / 1 | 0 / 1 | 1 / 1 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 7 Days up to 364 Days
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* CHI diagnosis established based on the following:
1. Hyperinsulinemia: plasma insulin above the limit of detection of the assay documented during an event of hypoglycemia, and/or
2. Hypofattyacidemia: plasma free fatty acid \<1.7 mmol/L, and/or
3. Hypoketonemia: Beta-hydroxybutyrate \<1.8 mmol/L, and/or
4. Glycemic response: an increase in plasma glucose (PG) of \>30 mg/dL (1.7 mmol/L) after 1 mg IV or intramuscular (IM) glucagon administration
* Male or female, age ≥7 days and \<12 months at screening
* Body weight of ≥2.0 kg (4.4 lbs.)
* Continuous IV glucose requirement to prevent hypoglycemia
Exclusion Criteria:
* Is suspected of having a transient form of CHI (e.g., transient hyperinsulinism due to maternal diabetes or perinatal stress)
* Was born preterm below 34 weeks of gestational age
* Presence of hypertension or hypotension, including circulatory instability requiring supportive medication or presence of pheochromocytoma
* Known or suspected presence of severe brain damage
* Evidence of metabolic, endocrine, or syndromic causes of hypoglycemia not due to hyperinsulinism
* Use of systemic corticosteroids, e.g., hydrocortisone \>20 mg/m\^2 body surface area or equivalent within 5 days before screening
* Prior use of lanreotide, sirolimus (mechanistic target of rapamycin \[mTOR\] inhibitors), anti-inflammatory biological agents, or other immune modulating agents. Prior use of octreotide is allowed after a minimum of 48 hour washout before randomization.
* Any clinically significant abnormality identified on echocardiogram that in the opinion of the investigator would affect the subject's ability to participate in the trial
* Any recognized clotting or bleeding disorder
* The use of prescription or non-prescription medications known to cause QT prolongation
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