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Intravenous Exenatide in Patients With Acute Brain Injury
Plain-language guide to NCT02058940: phase 4 interventional trial of Exenatide, 8 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02058940
- Phase
- phase 4
- Status
- completed
- Start
- 2015-08
- Completion (planned or actual)
- 2017-08
- Participants
- 8 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Brain Injuries
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Exenatide.
The purpose of this study is to assess the feasibility of exenatide infusion for the treatment of high blood sugars following acute brain injury.
It had 1 arm (groups): Exenatide (experimental).
The registry classes the interventions as drug.
Who Took Part
8 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Adults ≥18 years. Acute brain injury resulting in admission to the Neurosciences Intensive Care Unit for an anticipated length of stay \>48 hours. Informed consent obtained via proxy.
The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: pregnant (verified by urine or serum pregnancy test within 24 hours of initiation of infusion) or lactating females; type 1 diabetes mellitus; history of pancreatitis or risk factors for acute pancreatitis (i.e ethanol abuse, gall stones).
How the Study Was Run
The set-up was single-group and open-label.
Being open-label, the Exenatide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2015-08 with completion listed for 2017-08.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria (time frame: Over 48 hours from infusion initiation).
It also tracked 18 secondary outcomes, for example Median Glucose Concentration During Exenatide Infusion, Percentage of Glucose Measurements Within Goal Range, Glycemic Variability, Median Insulin Use, Percentage of Patients Requiring Rescue Insulin Infusion Protocol and Percentage of Patients Experiencing Metabolic Crisis.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Exenatide in 8 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.