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

NCT00571324 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-12-11

Study results available
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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.

Conditions

  • Congenital Hyperinsulinism

Interventions

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Diva De Leon

    lead OTHER

Principal Investigators

  • Diva D De Leon, MD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
7 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00571324 on ClinicalTrials.gov