Pharmacology of Exenatide in Pediatric Sepsis

NCT01573806 · Withdrawn

Last updated 2026-05-28

This clinical trial is testing the safety of the medication exenatide in children with septic shock to see how it affects inflammation, blood sugar control, organ function, and quality of life.

Status Withdrawn Stopped before any participant enrolled.

Phase Phase1, Phase2

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Who can join Ages 1 Month–18 · all sexes

Timeline Started 2012-10 · est. completion 2014-10

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT01573806 ↗

Description as written by the study sponsor.

Pharmacology of Exenatide in Pediatric Sepsis, PEPS is a phase 1-2 research study that will examine drug safety, drug metabolism, drug action and preliminary drug clinical effects of four does of exenatide injected every 12 hours to children with shock from infection (septic shock). The investigators hypothesize that exenatide can be safely dosed to children with sepsis to achieve blood levels of drug similar to that achieved in teenagers with type 2 diabetes. The investigators further hypothesize that injection of exenatide to children with septic shock will normalize blood glucose levels and decrease levels of inflammation proteins in the blood during the early course of sepsis.

Treatments tested

Exenatide Drug

Exenatide, dosed subcutaneously every 12 hours for 4 doses
Exenatide vehicle Drug

Exenatide vehicle, dosed subcutaneously every 12 hours for 4 doses

Main thing measured	Exenatide associated adverse event occurence
Sponsor	Seattle Children's Hospital
Conditions studied	Septic Shock, Inflammation, Glucose Homeostasis, Organ Dysfunction, Health-related Quality of Life
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01573806 ↗