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

• Status: Terminated
• Trial end date: 2017-01-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Diva De Leon

Criteria

Inclusion Criteria:

1. Confirmed clinical diagnosis of congenital hyperinsulinism

2. Infants less than 12 months of age at study enrollment

3. Failure to respond to treatment with diazoxide

Exclusion Criteria:

1. Evidence of a medical condition that might alter results, including kidney failure, severe liver dysfunction, severe respiratory or cardiac failure

2. Treatment with medications that may affect glucose metabolism at the time of initiation of study procedures, including:

1. Treatment with glucagon 4 hours prior to infusion (T=0)

2. Treatment with octreotide 24 hours prior to infusion (T=0)

3. Treatment with diazoxide 72 hours prior to infusion (T=0)

3. Suspected Beckwith-Wiedemann syndrome or other syndromic forms of congenital hyperinsulinism.