Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to examine the effects of exendin-(9-39) on fasting blood glucose and protein induced hypoglycemia on subjects with Congenital Hyperinsulinism. Funding Source - FDA Office of Orphan Products Development (OODP).


Clinical Trial Description

This is a placebo controlled study with randomized crossover design to evaluate the effect of the glucagon-like peptide-1 (GLP-1) receptor antagonist, exendin-(9-39), on fasting blood glucose levels, protein-induced hypoglycemia, and fasting tolerance of subjects with congenital hyperinsulinism due to mutations in the ATP- sensitive potassium channel (KATP) channel. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00897676
Study type Interventional
Source Children's Hospital of Philadelphia
Contact
Status Completed
Phase Phase 1/Phase 2
Start date May 2009
Completion date January 2017

See also
  Status Clinical Trial Phase
Recruiting NCT02021604 - Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma Phase 1
Recruiting NCT04732416 - HM15136 Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI) Phase 2
Completed NCT02937558 - CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism Phase 2
Completed NCT02604485 - A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism Phase 2
Recruiting NCT04205604 - 18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism Phase 2
Completed NCT00987168 - Sandostatine® LP and Hyperinsulinism Phase 2
Active, not recruiting NCT03941236 - Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism Phase 3
Completed NCT03042416 - 18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety Phase 3
Completed NCT04172441 - Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism Phase 2/Phase 3
Recruiting NCT04706910 - 18F-DOPA II - PET Imaging Optimization Phase 3
Recruiting NCT06208215 - RZ358 Treatment for Congenital Hyperinsulinism Phase 3
Completed NCT03777176 - A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism Phase 3
Recruiting NCT03768518 - GLP-1 Receptor Expression in CHI
Completed NCT04538989 - An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism Phase 2
Completed NCT01070758 - Lanreotide Autogel Treatment of Patients With Congenital Hyperinsulinism of Infancy Phase 4
Completed NCT00674440 - Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism Phase 2
Terminated NCT00835328 - Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia Phase 1/Phase 2
Completed NCT00571324 - Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism Phase 1/Phase 2
Withdrawn NCT03053284 - Pasireotide in Hyperinsulinemic Hypoglycemia Phase 2
No longer available NCT02835131 - Compassionate Use of SOM230 for Hyperinsulinemic/Hypoglycemia