Congenital Hyperinsulinism Clinical Trial
Official title:
An Open Label Pilot Study of the Effects of the Glucagon-like Peptide-1 Receptor Antagonist, Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism
The purpose of this study is to determine if Exendin-(9-39), an antagonist of the glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cell, increases fasting blood glucose levels in subjects with congenital hyperinsulinism.
This is an open-label, pilot study , to determine if Exendin-(9-39), an antagonist of the
glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cells, increases
fasting blood glucose levels in subjects with congenital hyperinsulinism. Our overall
hypothesis is that abnormal GLP-1 secretion resulting from dysfunctional nutrient sensing in
intestinal L-cells plays a role in the dysregulated insulin secretion characteristic of this
disorder, and that antagonism of the GLP-1 receptor will increase fasting blood glucose
levels.
Aim 1. To evaluate the dose of exendin-(9-39) required to elevate fasting blood glucose
levels in subjects with congenital hyperinsulinism due to KATP channel mutations.
Aim 2. To determine therapeutic plasma levels, plasma half-life and pharmacokinetics of
exendin-(9-39) during an intravenous short-term infusion in subjects with congenital
hyperinsulinism due to Adenosine triphosphate (ATP)-sensitive potassium channel (KATP)
mutations.
;
| 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 |
NCT00897676 -
Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity
|
Phase 1/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 | |
| Withdrawn |
NCT03053284 -
Pasireotide in Hyperinsulinemic Hypoglycemia
|
Phase 2 | |
| No longer available |
NCT02533219 -
Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia
|