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

Completed · Phase 2 · Has a placebo group

Conditions studied: Congenital Hyperinsulinism

In brief

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.

Key facts

Study ID

NCT02937558

Run by

Xeris Pharmaceuticals

People needed

5

Starts

2016-10-01

Expected to finish

2018-10-01

Last updated by the study team

2019-12-10

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with hyperinsulinism:
• a. Biochemical; detectable insulin (i.e., ≥1 µIU/L) at time of hypoglycemia (i.e, blood glucose <50 mg/dl), and/or suppressed free fatty acids (FFA), and/or suppressed beta-hydroxybutyrate (BOHB) and/or glycemic response to glucagon at time of hypoglycemia.
• Absolute necessity of intravenous glucose to prevent hypoglycemia:
• Having failed diazoxide therapy as defined by inadequacy of 5 days maximum dose of diazoxide to eliminate the need for IV glucose, not necessarily that diazoxide has no effect.
• May be on diazoxide and/or octreotide, but these drugs will be weaned off prior to randomization.
• May be on dextrose feeds.
• Patient may be a participant in other study protocols such as observational studies, as long as no investigational intervention has taken place within 24 hrs. prior to screening.
• Less than 12 months of age at screening.

You may not qualify if…

• History of allergy to glucagon or excipients in the CSI-Glucagon formulation.
• Currently receiving, or less than 12 hours removed from IV glucagon treatment that resulted in a best achievable GIR > 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.

Where it is running

• UCLA Mattel Children's Hospital — Los Angeles, California, United States
• UCSF School of Medicine, Division of Pediatric Endocrinology — San Francisco, California, United States
• Washington University, St. Louis Children's Hospital — St Louis, Missouri, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• Baylor College of Medicine, Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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