A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
NCT ID: NCT03777176
Last Updated: 2023-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
32 participants
INTERVENTIONAL
2019-02-07
2020-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
Dasiglucagon
Glucagon analog
Standard of Care
Standard of care according to site and/or country
Interventions
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Dasiglucagon
Glucagon analog
Standard of Care
Standard of care according to site and/or country
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
3 Months
12 Years
ALL
No
Sponsors
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Zealand Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Charlotte Teglman Schioeler
Role: STUDY_DIRECTOR
Zealand Pharma
Locations
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Children's Hospital of Colorado
Aurora, Colorado, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
University Hospital Düsseldorf, Department of Pediatrics
Düsseldorf, , Germany
Otto von Guericke University Magdeburg, Department of Pediatrics
Magdeburg, , Germany
Hadassah Medical Center
Jerusalem, , 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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ZP4207-17109
Identifier Type: -
Identifier Source: org_study_id