Congenital Hyperinsulinism Clinical Trial
Official title:
A Phase 2 Proof-of-Concept Study of CSI-Glucagon™ (Continuous Subcutaneous Glucagon Infusion) to Prevent Hypoglycemia With Lower Intravenous Glucose Infusion Rates in Children up to One Year of Age With Congenital Hyperinsulinism
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.
This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind (DB) parallel
group study with open-label follow-up designed to evaluate the efficacy of CSI-Glucagon™ for
the prevention of hypoglycemia with lower IV glucose infusion rates when delivered
subcutaneously to patients up to 1 year of age with congenital hyperinsulinism. CSI-Glucagon™
is expected to provide a better inpatient treatment option compared to the current standard
of care.
The study will consist of three phases:
1. Baseline Phase: First is a baseline stabilization phase during which concomitant therapy
with octreotide and diazoxide will be safely weaned and continuous enteric feed will be
held constant to the degree possible, with the only factors varying being meal size and
IV glucose infusion rate (GIR) adjusted by a set plasma glucose measurement driven
algorithm.
2. Blinded, Randomized Treatment Phase: Following the stabilization phase, subjects will be
randomly assigned to blinded treatment with either glucagon or placebo, which will be
delivered for up to 48 hours with an OmniPod® infusion pump with the controller set to a
starting basal rate for glucagon of 5 μg/kg/hr and GIR adjustments used to maintain
euglycemia. After 48 hours of blinded treatment, all subjects will transition to
open-label active treatment. However, if GIR reduction from baseline is < 20% at 24
hours, subjects will be transitioned early to the open-label phase.
3. Open-label Treatment Phase: The third study period will involve use of CSI-Glucagon™ to
manage blood glucose with minimal GIR for up to 28 days of cumulative exposure.
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