Phase 2 N=5 Randomized Quadruple-blind Prevention

CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism

Congenital Hyperinsulinism

Bottom Line

View on ClinicalTrials.gov: NCT02937558 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2019

Primary outcome: Primary: Number of Subjects With Clinically Meaningful Reduction in Glucose Infusion Rate (Double-Blind) — 2; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Glucagon (Drug); Placebo (Other)
Age: Pediatric
Sex: All
Sponsor: Xeris Pharmaceuticals
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Clinically Meaningful Reduction in Glucose Infusion Rate (Double-Blind)	2; 0	—
SECONDARY Percent Change in GIR (Double-Blind)	-50.1; 1.9	—
SECONDARY Number of Subjects With Clinically Meaningful Reduction in Glucose Infusion Rate (Open-Label)	4; 0	—
SECONDARY Percent Change in Glucose Infusion Rate (Open-Label)	-51.2	—

Summary

This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial with open-label follow-up designed to assess the efficacy of Xeris Glucagon delivered as a continuous subcutaneous infusion to prevent hypoglycemia with lower intravenous glucose infusion rates in children < 1 year of age with congenital hyperinsulinism.

Eligibility Criteria

Inclusion Criteria

Diagnosed with hyperinsulinism:

a. Biochemical; detectable insulin (i.e., ≥1 µIU/L) at time of hypoglycemia (i.e, blood glucose 8 mg/(kg*min), prior to the start of study drug.

Diazoxide naïve or within five days of starting diazoxide.
Receiving steroids at doses larger than 20 mg/m2/day (hydrocortisone equivalent).
Patients with sepsis.
Receiving alpha or beta agonists for blood pressure support.
Received an investigational or other study drug within 5 half-lives of drug.
Body weight less than or equal to 2.3 kg/5.0 lbs.
History of pancreatectomy and GIR < 8 mg/(kg*min) after weaning of all concomitant therapies.

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Data sourced from ClinicalTrials.gov (NCT02937558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.