Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism

NCTNCT03941236Other idZP4207-17106

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 42 participants (actual)
Sponsor: Zealand Pharma · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 4 countries
United States, Germany, Israel, United Kingdom
Start: 2 May 2019
Primary completion: 28 Jan 2025
Completion: 26 May 2026
First posted: 7 May 2019
Last update posted: 3 Aug 2026
Conditions: Congenital Hyperinsulinism

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2020202220242026

Ph 3
Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism
NCT03941236
2 May 2019 to 26 May 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is an open-label, multinational, multicenter, long-term safety and efficacy extension trial in patients with Congenital Hyperinsulinism (CHI) who completed either ZP4207-17103 (NCT04172441) or ZP4207-17109 (NCT03777176) (defined as lead-in trials). The primary objective is to evaluate the long-term safety of dasiglucagon administered as a subcutaneous (SC) infusion in children with CHI.

Interventions

dasiglucagonDrug

Arms1

Experimental
Dasiglucagon open-label
Dasiglucagon treatment as an SC infusion in the dose range 10-70 μg/h titrated individually

Primary outcomes1

Outcomes the sponsor listed as primary.

Adverse Events
Time frame · Baseline through treatment completion, up to 3 years
Registry description
Number of adverse events occurring up to Month 1, Month 1 to Month 3 and in each 3-month period for the first year; subsequent years will have longer periods assigned for analysis

Secondary outcomes(15)

Amount of gastric carbohydrates administered to treat hypoglycemia
Time frame · Baseline through treatment completion, up to 3 years
Registry description
Total amount of gastric carbohydrates administered via nasogastric tube or gastrostomy per week to treat hypoglycemia
Nasogastric (NG) tube or gastrostomy removal
Time frame · Baseline through treatment completion, up to 3 years
Registry description
Time to removal of NG tube or gastrostomy
Pancreatic surgery
Time frame · Baseline through treatment completion, up to 3 years
Registry description
Time to pancreatic surgery (sub-total or total pancreatectomy)
Time in hypoglycemia
Time frame · Baseline through treatment completion, up to 3 years
Registry description
Continuous glucose monitoring (CGM) percent time \<70 mg/dL (3.9 mmol/L)
Hypoglycemia episodes
Time frame · Baseline through treatment completion, up to 3 years
Registry description
Rate of CGM-detected hypoglycemia episodes \<70 mg/dL (3.9 mmol/L) for 15 minutes or more
Clinically significant episodes of hypoglycemia
Time frame · Baseline through treatment completion, up to 3 years
Registry description
Rate of clinically significant CGM-detected hypoglycemia episodes \<54 mg/dL (3.0 mmol/L) for 15 minutes or more
Gastric carbohydrate administrations
Time frame · Baseline through treatment completion, up to 3 years
Registry description
Number of gastric carbohydrate administrations (nasogastric tube or gastrostomy) to treat hypoglycemia
Nightly gastric carbohydrate administrations
Time frame · Baseline through treatment completion, up to 3 years
Registry description
Number of nightly (midnight to 6 am) gastric carbohydrate administrations (nasogastric tube or gastrostomy) to treat hypoglycemia
Extent of hypoglycemia
Time frame · Baseline through treatment completion, up to 3 years
Registry description
Extent of hypoglycemia (area over the glucose curve \[AOCglucose\] below 70 mg/dL \[3.9 mmol/L\]) as measured by continous glucose monitoring (CGM)
Extent of clinically significant hypoglycemia
Time frame · Baseline through treatment completion, up to 3 years
Registry description
Extent of hypoglycemia (area over the glucose curve \[AOCglucose\] below 54 mg/dL \[3.0 mmol/L\]) as measured by continous glucose monitoring (CGM)
Diazoxide dose
Time frame · Baseline through treatment completion, up to 3 years
Registry description
Reduction in diazoxide dose in mg/kg body weight/day from start of lead-in trial
Somatostatin analog dose
Time frame · Baseline through treatment completion, up to 3 years
Registry description
Reduction in somatostatin analog dose from start of lead-in trial
Prescribed amount of continuous gastric carbohydrate administration
Time frame · Baseline through treatment completion, up to 3 years
Registry description
Change in total amount of prescribed continuous gastric carbohydrate administration from start of lead-in trial (g/day)
Prescribed duration of continuous gastric carbohydrate administration
Time frame · Baseline through treatment completion, up to 3 years
Registry description
Change in prescribed duration of infusion of continuous gastric carbohydrate administration from start of lead-in trial (h/day)
Prescribed duration of nightly continuous gastric carbohydrate administration
Time frame · Baseline through treatment completion, up to 3 years
Registry description
Change in prescribed duration of infusion of nightly (8 pm - 8 am) continuous gastric carbohydrate administration from start of lead-in trial (h/day)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

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 5 Weeks up to 13 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Completed treatment in either Trial ZP4207-17103 or ZP4207-17109 * Expected to continue to have a positive benefit-risk assessment for treatment with dasiglucagon (based on considerations of glycemic effect, tolerability, and nature and frequency of adverse events experienced in the lead-in trial) Exclusion Criteria: * The patient developed any conditions prohibited by the lead-in trial, requires medication prohibited by the lead-in trial, or has other new complications that preclude participation in the investigator's opinion.

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