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NCT Number: NCT03941236

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Congenital Hyperinsulinism Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Glucose Metabolism Disorders Hyperinsulinism Hypoglycemia Infant, Newborn, Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pancreatic Diseases

Age range

5 week–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Düsseldorf, Department of Pediatrics, Düsseldorf, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dasiglucagon

Drug

Glucagon analog

Other names: ZP4207

Primary outcomes

  1. Adverse Events

    Time frame: Baseline through treatment completion, up to 3 years

    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

  1. Amount of gastric carbohydrates administered to treat hypoglycemia

    Time frame: Baseline through treatment completion, up to 3 years

    Total amount of gastric carbohydrates administered via nasogastric tube or gastrostomy per week to treat hypoglycemia

  2. Nasogastric (NG) tube or gastrostomy removal

    Time frame: Baseline through treatment completion, up to 3 years

    Time to removal of NG tube or gastrostomy

  3. Pancreatic surgery

    Time frame: Baseline through treatment completion, up to 3 years

    Time to pancreatic surgery (sub-total or total pancreatectomy)

  4. Time in hypoglycemia

    Time frame: Baseline through treatment completion, up to 3 years

    Continuous glucose monitoring (CGM) percent time <70 mg/dL (3.9 mmol/L)

  5. Hypoglycemia episodes

    Time frame: Baseline through treatment completion, up to 3 years

    Rate of CGM-detected hypoglycemia episodes <70 mg/dL (3.9 mmol/L) for 15 minutes or more

  6. Clinically significant episodes of hypoglycemia

    Time frame: Baseline through treatment completion, up to 3 years

    Rate of clinically significant CGM-detected hypoglycemia episodes <54 mg/dL (3.0 mmol/L) for 15 minutes or more

  7. Gastric carbohydrate administrations

    Time frame: Baseline through treatment completion, up to 3 years

    Number of gastric carbohydrate administrations (nasogastric tube or gastrostomy) to treat hypoglycemia

  8. Nightly gastric carbohydrate administrations

    Time frame: Baseline through treatment completion, up to 3 years

    Number of nightly (midnight to 6 am) gastric carbohydrate administrations (nasogastric tube or gastrostomy) to treat hypoglycemia

  9. Extent of hypoglycemia

    Time frame: Baseline through treatment completion, up to 3 years

    Extent of hypoglycemia (area over the glucose curve [AOCglucose] below 70 mg/dL [3.9 mmol/L]) as measured by continous glucose monitoring (CGM)

  10. Extent of clinically significant hypoglycemia

    Time frame: Baseline through treatment completion, up to 3 years

    Extent of hypoglycemia (area over the glucose curve [AOCglucose] below 54 mg/dL [3.0 mmol/L]) as measured by continous glucose monitoring (CGM)

  11. Diazoxide dose

    Time frame: Baseline through treatment completion, up to 3 years

    Reduction in diazoxide dose in mg/kg body weight/day from start of lead-in trial

  12. Somatostatin analog dose

    Time frame: Baseline through treatment completion, up to 3 years

    Reduction in somatostatin analog dose from start of lead-in trial

  13. Prescribed amount of continuous gastric carbohydrate administration

    Time frame: Baseline through treatment completion, up to 3 years

    Change in total amount of prescribed continuous gastric carbohydrate administration from start of lead-in trial (g/day)

  14. Prescribed duration of continuous gastric carbohydrate administration

    Time frame: Baseline through treatment completion, up to 3 years

    Change in prescribed duration of infusion of continuous gastric carbohydrate administration from start of lead-in trial (h/day)

  15. Prescribed duration of nightly continuous gastric carbohydrate administration

    Time frame: Baseline through treatment completion, up to 3 years

    Change in prescribed duration of infusion of nightly (8 pm - 8 am) continuous gastric carbohydrate administration from start of lead-in trial (h/day)

Sponsors and collaborators

Lead sponsor

Zealand Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
May 7, 2019
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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