Primary outcomeMean· Baseline, Week 2-4 (Treatment Period 1)
Hypoglycemia Episode Rate
| Group | Value (episodes per week) | Spread |
|---|---|---|
| Standard of Care + Dasiglucagon | 5.29 | 5.256 |
| Standard of Care Only | 5.85 | 2.767 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
NCTNCT03777176 (opens ClinicalTrials.gov in a new tab)Other idZP4207-17109
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 32 participants (actual)
- Sponsor
- Zealand Pharma · Industry
- Design
- Randomized · Open label (no masking)
- Countries
4 countries
United States, Germany, Israel, United Kingdom
- Start
- 7 Feb 2019
- Primary completion
- 31 Aug 2020
- Completion
- 5 Oct 2020
- First posted
- 17 Dec 2018
- Last update posted
- 13 Dec 2023
- Conditions
- Congenital Hyperinsulinism
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201920202021
- Ph 3
A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
NCT037771767 Feb 2019 to 5 Oct 2020
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 and safety of dasiglucagon administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.
Interventions
- DasiglucagonDrug
- Standard of CareOther
Arms2
Experimental
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
Other
Standard of Care Only
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
Primary outcomes1
Outcomes the sponsor listed as primary.
Hypoglycemia Episode Rate
Time frame · Baseline, Week 2-4 (Treatment Period 1)
Registry description
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.
Secondary outcomes(14)
Increase in Fasting Tolerance
Time frame · Baseline, Week 2-4 (Treatment Period 1)
Registry description
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.
Percent Time in Range 70-180 mg/dL
Time frame · Baseline, Week 2-4 (Treatment Period 1)
Registry description
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.
Clinically Significant Hypoglycemia Episode Rates
Time frame · Baseline, Week 2-4 (Treatment Period 1)
Registry description
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.
Total Amount of Gastric Carbohydrates Administered to Treat Hypoglycemia
Time frame · Baseline, Week 2-4 (Treatment Period 1)
Registry description
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.
Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia
Time frame · Baseline, Week 2-4 (Treatment Period 1)
Registry description
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.
Extent of Hypoglycemia
Time frame · Baseline, Week 2-4 (Treatment Period 1)
Registry description
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.
Amount of Nightly Gastric Carbohydrates Administered
Time frame · Baseline, Week 2-4 (Treatment Period 1)
Registry description
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.
Total Amount of Gastric Carbohydrates Administered
Time frame · Baseline, Week 2-4 (Treatment Period 1)
Registry description
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.
Percent Time in Hypoglycemia
Time frame · Baseline, Week 2-4 (Treatment Period 1)
Registry description
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.
Rate of Hypoglycemic Episodes
Time frame · Baseline, Week 2-4 (Treatment Period 1)
Registry description
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.
Percent Time in Hypoglycemia in Treatment Period 2
Time frame · Baseline, Week 6-8 (Treatment Period 2)
Registry description
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.
Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia in Treatment Period 2
Time frame · Baseline, Week 6-8 (Treatment Period 2)
Registry description
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.
Rate of Hypoglycemic Episodes in Treatment Period 2
Time frame · Baseline, Week 6-8 (Treatment Period 2)
Registry description
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.
Rate of Clinically Significant Hypoglycemia Episodes in Treatment Period 2
Time frame · Baseline, Week 6-8 (Treatment Period 2)
Registry description
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.
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· Baseline, Week 2-4 (Treatment Period 1)
Increase in Fasting Tolerance
| Group | Value (hours) | Spread |
|---|---|---|
| Standard of Care + Dasiglucagon | 6.13 | 5.335 |
| Standard of Care Only | 4.22 | 4.222 |
Secondary outcomeMean· Baseline, Week 2-4 (Treatment Period 1)
Percent Time in Range 70-180 mg/dL
| Group | Value (percent time) | Spread |
|---|---|---|
| Standard of Care + Dasiglucagon | 75.10 | 11.821 |
| Standard of Care Only | 72.65 | 7.313 |
Secondary outcomeMean· Baseline, Week 2-4 (Treatment Period 1)
Clinically Significant Hypoglycemia Episode Rates
| Group | Value (episodes per week) | Spread |
|---|---|---|
| Standard of Care + Dasiglucagon | 1.77 | 1.857 |
| Standard of Care Only | 1.90 | 1.407 |
Secondary outcomeMean· Baseline, Week 2-4 (Treatment Period 1)
Total Amount of Gastric Carbohydrates Administered to Treat Hypoglycemia
| Group | Value (grams) | Spread |
|---|---|---|
| Standard of Care + Dasiglucagon | 22.89 | 31.415 |
| Standard of Care Only | 37.66 | 57.998 |
Secondary outcomeMean· Baseline, Week 2-4 (Treatment Period 1)
Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia
| Group | Value (number of administrations per week) | Spread |
|---|---|---|
| Standard of Care + Dasiglucagon | 2.30 | 3.433 |
| Standard of Care Only | 2.18 | 2.714 |
Secondary outcomeMean· Baseline, Week 2-4 (Treatment Period 1)
Extent of Hypoglycemia
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Standard of Care + Dasiglucagon | 0.083 | 0.0618 |
| Standard of Care Only | 0.147 | 0.0736 |
Secondary outcomeMean· Baseline, Week 2-4 (Treatment Period 1)
Amount of Nightly Gastric Carbohydrates Administered
| Group | Value (grams) | Spread |
|---|---|---|
| Standard of Care + Dasiglucagon | 95.98 | 153.272 |
| Standard of Care Only | 33.43 | 90.955 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Treatment Period 1: Standard of Care + DasiglucagonAll 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 |
| Treatment Period 1: Standard of Care OnlyAll 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 |
| Treatment Period 2: Standard of Care + DasiglucagonAll 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 |
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 3 Months up to 12 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Established and documented diagnosis of CHI based on standard of care
* Experiencing ≥3 events of hypoglycemia per week (plasma glucose \[PG\] \<70 mg/dL \[\<3.9 mmol/L\]) according to the investigator's evaluation
* Previously undergone near-total pancreatectomy or being treated with a non-surgical approach, having been evaluated as not eligible for pancreatic surgery
* If somatostatin analogues or sirolimus are used, the therapy should be well established as judged by the investigator, especially when considering their biological half-life
Exclusion Criteria:
* Previous administration of dasiglucagon
* Known or suspected allergy to the trial drug or related products
* Previous participation (randomization) in this trial
* Circulatory instability requiring supportive medication or presence of pheochromocytoma
* Requires exogenous insulin
* Body weight of \<4 kg (8.8 lbs.)
* Documented HbA1c ≥7% subsequent to near-total pancreatectomy and within 6 months prior to screening
* Known or suspected presence of significant central nervous system disease/injury such that in the investigator's opinion will affect trial participation
* Use of systemic corticosteroids, e.g., hydrocortisone \>20 mg/m2 body surface area or equivalent in the 5 days before screening
* Use of anti-inflammatory biological agents, or other immune modulating agents in the 3 months prior to screening
* Any clinically significant abnormality identified on echocardiogram that in the opinion of the investigator would affect the patient's ability to participate in the trial
* Any recognized clotting or bleeding disorders
* Has participated in an interventional clinical trial (investigational or marketed product) within 3 months of screening or 5 half-lives of the drug under investigation (whichever comes first), or plans to participate in another clinical trial.
PepBank is a research reference. Talk to a doctor before you use any peptide.