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Sponsors and Collaborators: |
Children's Hospital of Philadelphia National Institutes of Health (NIH) |
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Information provided by: | Children's Hospital of Philadelphia |
ClinicalTrials.gov Identifier: | NCT00571324 |
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.
Condition | Intervention | Phase |
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Congenital Hyperinsulinism |
Drug: exendin-(9-39) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Open Label, Single Group Assignment |
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 |
Estimated Enrollment: | 10 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: exendin-(9-39)
A short term intravenous infusion of exendin-(9-39) over 6 hours.
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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 KATP channel mutations.
Ages Eligible for Study: | 7 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Susan O'Rourke | 267-426-7251 | orourkes@email.chop.edu |
Contact: Stephanie Givler | 267-426-7622 | givler@email.chop.edu |
United States, Pennsylvania | |
The Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Principal Investigator: Diva D De Leon, MD | |
Sub-Investigator: Charles A Stanley, MD |
Principal Investigator: | Diva D De Leon, MD | Children's Hospital of Philadelphia |
Responsible Party: | The Children's Hospital of Philadelphia ( Diva D De Leon, MD/ Assistant Professor of Pediatrics ) |
Study ID Numbers: | 2007-1-5131, R03DK078535-01 |
Study First Received: | December 10, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00571324 |
Health Authority: | United States: Food and Drug Administration |
hyperinsulinism hypoglycemia KATP channel SUR-1 Kir6.2 |
Hyperinsulinism Metabolic Diseases Nesidioblastosis of pancreas Hyperinsulinemic hypoglycemia, familial, 1 Glucagon Infant, Newborn, Diseases |
Metabolic disorder Glucose Metabolism Disorders Hypoglycemia Persistent Hyperinsulinemia Hypoglycemia of Infancy Glucagon-Like Peptide 1 |