NCT00571324

Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Diva De Leon · Academic / Other
• Sex: All
• Age: 7 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Congenital Hyperinsulinism

Interventions

Type	Name	Description
DRUG	Exendin-(9-39)	A short term intravenous infusion of the study drug, exendin-(9-39), will be given over 6 hours.
OTHER	Vehicle	A short term intravenous infusion of normal saline, or the vehicle, will be given over 6 hours.

Timeline

• Start date: 2007-08-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2007-12-12
• Last updated: 2017-12-11
• Results posted: 2016-11-09

Locations

1 site across 1 country: United States