drugset / Trial / NCT00835328

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

NCT00835328

Phase 1/2 Terminated 14 enrolled Diva De Leon
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Avexitide Peptide 0.02 mg/kg Intravenous
Subject Avexitide Peptide 0.04 mg/kg Intravenous
Subject Avexitide Peptide 0.1 mg/kg Intravenous
Subject Avexitide Peptide 0.2 mg/kg Intravenous