Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity

NCT00897676 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-03-13

Study results available
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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).

Conditions

  • Congenital Hyperinsulinism

Interventions

DRUG

Exendin-(9-39)

100-500pmol/kg/min

DRUG

placebo

placebo (0.9% NaCl)

Sponsors & Collaborators

  • Diva De Leon

    lead OTHER

Principal Investigators

  • Diva D DeLeon, MD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2016-08-26
Completion
2017-01-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00897676 on ClinicalTrials.gov