Congenital Hyperinsulinism Clinical Trial
Official title:
An Open Label Pilot Study of the Effects of the Glucagon-like Peptide-1 Receptor Antagonist, Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism
The purpose of this study is to determine if Exendin-(9-39), an antagonist of the glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cell, increases fasting blood glucose levels in subjects with congenital hyperinsulinism.
This is an open-label, pilot study , to determine if Exendin-(9-39), an antagonist of the
glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cells, increases
fasting blood glucose levels in subjects with congenital hyperinsulinism. Our overall
hypothesis is that abnormal GLP-1 secretion resulting from dysfunctional nutrient sensing in
intestinal L-cells plays a role in the dysregulated insulin secretion characteristic of this
disorder, and that antagonism of the GLP-1 receptor will increase fasting blood glucose
levels.
Aim 1. To evaluate the dose of exendin-(9-39) required to elevate fasting blood glucose
levels in subjects with congenital hyperinsulinism due to KATP channel mutations.
Aim 2. To determine therapeutic plasma levels, plasma half-life and pharmacokinetics of
exendin-(9-39) during an intravenous short-term infusion in subjects with congenital
hyperinsulinism due to Adenosine triphosphate (ATP)-sensitive potassium channel (KATP)
mutations.
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