CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Exendin-(9-39) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00897676
NCT00897676Phase 2Completed
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Role of GLP-1 in Congenital Hyperinsulinism:Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity

Diva De Leon·interventional·Posted May 12, 2009·Updated Mar 13, 2020

In Brief

A Phase 2 clinical trial evaluating Exendin-(9-39) and placebo for Congenital Hyperinsulinism. Completed, enrolled 17 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Hyperinsulinism
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 12, 2009
Enrollment StartMay 1, 2009
Primary CompletionAug 26, 2016
Study CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 17.1 years ago

Interventions

Exendin-(9-39)drug

100-500pmol/kg/min

placebodrug

placebo (0.9% NaCl)