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Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia

NCT00835328 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-06-01

Study results available
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Summary

The primary aim of this study is to evaluate the effect of Exendin (9-39) on glucose requirements to maintain euglycemia in pediatric patients with congenital hyperinsulinism (CHI) who have failed medical therapy. The secondary aims are to determine the therapeutic plasma levels, plasma half-life and pharmacokinetics of Exendin (9-39) during a 9-hour intravenous infusion.

Conditions

  • Congenital Hyperinsulinism

Interventions

DRUG

Exendin (9-39)

A short-term intravenous infusion of the investigational drug, Exendin (9-39), will be administered over up to 9 hours.

DRUG

Vehicle

A short-term intravenous infusion of normal saline (0.9% NaCl), or the vehicle, will be administered over up to 9 hours.

Sponsors & Collaborators

  • Diva De Leon

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-26
Primary Completion
2017-01-28
Completion
2017-01-28

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 NCT00835328 on ClinicalTrials.gov