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Pharmacology of Exenatide in Pediatric Sepsis
Plain-language guide to NCT01573806: phase 1, phase 2 randomized trial of Exenatide. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01573806
- Phase
- phase 1, phase 2
- Status
- withdrawn
- Start
- 2012-10
- Completion (planned or actual)
- 2014-10
- Participants
- n/a (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Septic Shock; Inflammation; Glucose Homeostasis; Organ Dysfunction; Health-related Quality of Life
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1, phase 2) is built around Exenatide.
It had two arms (groups): Exenatide (active comparator) and Exenatide vehicle (placebo comparator).
Subjects dosed with exenatide in Phase 2.
Subjects dosed with exenatide vehicle in Phase 2.
The registry classes the interventions as drug.
More on the Plan
A total of 18 subjects are expected to be enrolled in Phase 1.
In Phase 2, 30 subjects in each age strata in the ratio of 4:1, exenatide: vehicle, are expected to be enrolled.
Who Took Part
It was open to people of any sex aged from 1 Month up to 18 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age 44 weeks estimated gestational age to 18 years AND. Admitted to the PICU for the sepsis event AND. Vascular catheter capable of providing serial blood samples in place AND. Diagnosis of septic shock = sepsis with cardiovascular organ dysfunction AND. Parents speak English or Spanish.
The full record lists 5 inclusion and 16 exclusion criteria; among the exclusions: greater than 12 hours from admission to picu to enrollment or; chronic or acute dialytic therapy, history of renal impairment or renal transplantation or; history of pancreatitis or.
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received Exenatide.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2012-10 with completion listed for 2014-10.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 1, phase 2, randomized trial of Exenatide in people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Exenatide compound page, all human trials.
Our Notes on the Compound
Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.