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

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Congenital Hyperinsulinism

In brief

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.

Key facts

Study ID

NCT00835328

Run by

Diva De Leon

People needed

14

Starts

2009-08-26

Expected to finish

2017-01-28

Last updated by the study team

2020-06-01

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed clinical diagnosis of congenital hyperinsulinism
• Infants less than 12 months of age at study enrollment
• Failure to respond to treatment with diazoxide

You may not qualify if…

• Evidence of a medical condition that might alter results, including kidney failure, severe liver dysfunction, severe respiratory or cardiac failure
• Treatment with medications that may affect glucose metabolism at the time of initiation of study procedures, including:
• Treatment with glucagon 4 hours prior to infusion (T=0)
• Treatment with octreotide 24 hours prior to infusion (T=0)
• Treatment with diazoxide 72 hours prior to infusion (T=0)
• Suspected Beckwith-Wiedemann syndrome or other syndromic forms of congenital hyperinsulinism.

Where it is running

• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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