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Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism

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ClinicalTrials.gov Identifier: NCT03777176
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Zealand Pharma

Brief Summary:
The objective of the trial is to evaluate the efficacy of dasiglucagon administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.

Condition or disease Intervention/treatment Phase
Congenital Hyperinsulinism Drug: dasiglucagon Other: Standard of Care Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two-Period, Open-label Trial Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children With Congenital Hyperinsulinism
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
Experimental: Standard of Care + dasiglucagon
8 weeks of dasiglucagon treatment as sc infusion starting at 10 µg/hr on top of standard of care
Drug: dasiglucagon
Glucagon analog
Other Name: ZP4207

Other: Standard of Care
Standard of care according to site and/or country

Standard of Care
4 weeks of standard of care + 4 weeks of dasiglucagon treatment as sc infusion starting at 10 µg/hr on top of standard of care
Drug: dasiglucagon
Glucagon analog
Other Name: ZP4207

Other: Standard of Care
Standard of care according to site and/or country




Primary Outcome Measures :
  1. Hypoglycemia events [ Time Frame: Weeks 2-4 ]
    Hypoglycemia event rate, defined as average weekly number of hypoglycemic events (PG <70 mg/dL [3.9 mmol/L]) as detected by self-monitored plasma glucose


Secondary Outcome Measures :
  1. Fasting tolerance [ Time Frame: Baseline to week 4 ]
    Increase in fasting tolerance (time from beginning of meal to the beginning of the first continuous 15-minute continous glucose monitorting reading <70 mg/dL [3.9 mmol/L])

  2. Gastric carbohydrates administered to treat hypoglycemia [ Time Frame: Week 2-4 ]
    Total amount of gastric carbohydrates adminstered via nasogastric tube or gastrostomy per week to treat hypoglycemia

  3. Time in range [ Time Frame: Week 2-4 ]
    Percent time in range 70-180 mg/dL (3.9-10.0 mmol/L) as measured by continous glucose monitoring

  4. Clinically significant hypoglycemia events [ Time Frame: Week 2-4 ]
    Clinically significant hypoglycemia event rates, defined as average weekly number of events <54 mg/dL (3.0 mmol/L), as detected my self-measured plasma glucose

  5. Gastric carbohydrates administrations to treat hypoglycemia [ Time Frame: Week 2-4 ]
    Rate of gastric carbohydrate administrations via nasogastric tube or gastrostomy per week to treat hypoglycemia

  6. Extent of hypoglycemia [ Time Frame: Week 2-4 ]
    Extent of hypoglycemia (area over the glucose curve [AOCglucose] below 70 mg/dL [3.9 mmol/L]) as measured by continous glucose monitorting

  7. Nightly gastric carbohydrates administered [ Time Frame: Week 2-4 ]
    Amount of nightly (midnight to 6 am) gastric carbohydrates administered via nasogastric tube or gastrostomy per week

  8. Gastric carbohydrates administered [ Time Frame: Week 2-4 ]
    Total amount of gastric carbohydrates administered via nasogastric tube or gastrostomy per week

  9. Time in hypoglycemia [ Time Frame: Week 2-4 ]
    Percent time in hypoglycemia (<70 mg/dL [3.9 mmol/L]) as measured by continous glucose monitoring

  10. Rate of hypoglycemic episodes [ Time Frame: Week 2-4 ]
    Rate of hypoglycemic episodes, defined as number of episodes <70 mg/dL (3.9 mmol/L) for 15 minutes or more per week, as measured by continous glucose monitoring

  11. Time in hypoglycemia in treatment period 2 [ Time Frame: Week 6-8 ]
    Percent time in hypoglycemia (<70 mg/dL [3.9 mmol/L]) as measured by continous glucose monitoring

  12. Gastric carbohydrates administrations to treat hypoglycemia in treatment period 2 [ Time Frame: Week 6-8 ]
    Average weekly number of gastric carbohydrate administrations via nasogastric tube or gastrostomy to treat hypoglycemia

  13. Hypoglycemic events in treatment period 2 [ Time Frame: Week 6-8 ]
    Hypoglycemia event rate, defined as average weekly number of hypoglycemic events (PG <70 mg/dL [3.9 mmol/L]) as detected by self-monitored plasma glucose

  14. Clinically significant hypoglycemia events in treatment period 2 [ Time Frame: Week 6-8 ]
    Clinically significant hypoglycemia event rates, defined as average weekly number of events <54 mg/dL (3.0 mmol/L), for 15 minutes or more as measured by continous glucose monitorting (CGM)



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Ages Eligible for Study:   3 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Established and documented diagnosis of CHI based on standard of care
  • Experiencing ≥3 events of hypoglycemia per week (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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777176


Contacts
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Contact: Benedikte Bandak +4550603766 bba@zealandpharma.com

Locations
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United States, California
Rady Children's Hospital San Diego Recruiting
San Diego, California, United States, 92093
United States, Colorado
Children's Hospital of Colorado Recruiting
Aurora, Colorado, United States, 13123
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Germany
University Hospital Düsseldorf, Department of Pediatrics Not yet recruiting
Düsseldorf, Germany, 40225
Otto von Guericke University Magdeburg, Department of Pediatrics Not yet recruiting
Magdeburg, Germany, 39120
Israel
Hadassah Medical Center Recruiting
Jerusalem, Israel, 9765422
United Kingdom
NHS Greater Glasgow and Clyde Recruiting
Glasgow, United Kingdom
Alder Hey Children'sHospital NHS Foundation Trust Recruiting
Liverpool, United Kingdom
Great Osmond Street Hospital for Children NHS Foundation Trust Recruiting
London, United Kingdom
Central Manchester University Hospital NHS Foundation Trust Recruiting
Manchester, United Kingdom
Sponsors and Collaborators
Zealand Pharma
Investigators
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Study Director: Benedikte Bandak Zealand Pharma

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Responsible Party: Zealand Pharma
ClinicalTrials.gov Identifier: NCT03777176     History of Changes
Other Study ID Numbers: ZP4207-17109
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Congenital Hyperinsulinism
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases
Infant, Newborn, Diseases
Hypoglycemia