What side effects are associated with this type of intervention?

Common treatments for Congenital Hyperinsulinism (CHI) that stimulate the liver to release stored glucose, such as dasiglucagon, often have side effects including nausea, vomiting, and headache. Injection site reactions like redness or swelling can also occur. In rare cases, allergic reactions may be observed.

What prior FDA approvals exist?

The FDA has approved several treatments for Congenital Hyperinsulinism (CHI), focusing on managing hypoglycemia by stimulating the liver to release glucose. Diazoxide is one such drug that inhibits insulin release and is commonly used in CHI. Octreotide, a somatostatin analog, is another treatment that reduces insulin secretion. While dasiglucagon, which stimulates the liver to release stored glucose, is currently being studied, it represents a promising addition to the treatment options for CHI. These treatments aim to maintain normal blood glucose levels and prevent hypoglycemic episodes in affected individuals.

What other types of research exist?

A promising novel alternative to Dasiglucagon for Congenital Hyperinsulinism patients is the use of somatostatin analogs, which help manage hypoglycemia by suppressing insulin secretion.

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Glucagon Receptor Agonist

Dasiglucagon for Congenital Hyperinsulinism

Phase 3

Waitlist Available

Research Sponsored by Zealand Pharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through treatment completion, up to 3 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing the long-term safety of dasiglucagon, an injectable medication, in children with Congenital Hyperinsulinism (CHI). Dasiglucagon works by raising blood sugar levels through prompting the liver to release stored sugar. Dasiglucagon is stable and well-absorbed, lasting longer in the body compared to traditional treatments.

Who is the study for?

This trial is for children with Congenital Hyperinsulinism who completed prior trials ZP4207-17103 or ZP4207-17109. They should continue to benefit from dasiglucagon, without new conditions or complications that would prevent safe participation as judged by the investigator.

What is being tested?

The trial tests the long-term safety and effectiveness of dasiglucagon, a medication given through under-the-skin injections, in managing blood sugar levels in children with Congenital Hyperinsulinism.

What are the potential side effects?

Possible side effects include reactions at the injection site, low blood sugar events (hypoglycemia), and other adverse effects noted during previous studies. The exact profile will be monitored over time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through treatment completion, up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through treatment completion, up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through treatment completion, up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Secondary study objectives

Amount of gastric carbohydrates administered to treat hypoglycemia

Clinically significant episodes of hypoglycemia

Diazoxide dose

+12 more

Side effects data

From 2018 Phase 3 trial • 112 Patients • NCT03216226

47%

Hypoglycemia

46%

Nausea

21%

Vomiting

14%

Headache

11%

Viral upper respiratory tract infection

Diarrhea

Hyperglycemia

Leukocytosis

Upper respiratory tract infection

Dizziness

Hypotension

Fatigue

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Dasiglucagon (ZP4207)

GlucaGen

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dasiglucagon open-labelExperimental Treatment1 Intervention

Dasiglucagon treatment as sc infusion starting at 10 µg/hr on top of standard of care

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

dasiglucagon

2018

Completed Phase 3

~260

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Congenital Hyperinsulinism (CHI) include diazoxide, octreotide, and glucagon analogs like dasiglucagon. Diazoxide inhibits insulin release by opening potassium channels in pancreatic beta cells. Octreotide suppresses insulin secretion by inhibiting hormone release. Dasiglucagon stimulates the liver to release stored glucose, counteracting hypoglycemia. These treatments are vital for CHI patients to manage persistent hypoglycemia and prevent severe neurological damage.

Idiopathic hypoglycaemia in sibs with morphological evidence of nesidioblastosis of the pancreas.Prenatal Oxygen and Glucose Therapy Normalizes Insulin Secretion and Action in Growth-Restricted Fetal Sheep.Prenatal Oxygen and Glucose Therapy Normalizes Insulin Secretion and Action in Growth Restricted Fetal Sheep.