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Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus
Plain-language guide to NCT01144338: phase 3 randomized trial of Exenatide, 14752 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01144338
- Phase
- phase 3
- Status
- completed
- Start
- 2010-06-18
- Completion (planned or actual)
- 2017-04-21
- Participants
- 14752 (actual)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Exenatide.
It had two arms (groups): Exenatide Once Weekly (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
14752 actual participants took part.
It was open to people of any sex aged from 18 years up to 130 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patient has type 2 diabetes mellitus.
The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis; patient has ever been treated with an approved or investigational glp-1 receptor agonist; patient has a planned or anticipated revascularization procedure.
How the Study Was Run
It was run as a randomized, parallel-group and triple-blind study.
The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Neither the participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, investigator and outcomes assessor.
It started in 2010-06-18 with completion listed for 2017-04-21.
It ran at 629 sites in United States (139), Germany (35), Hungary (33), United Kingdom (29), Canada (28) and Ukraine (24).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Primary Safety Outcome MACE Events (time frame: Time to first event. Information collected during study period (anticipated to be up to 7.5 years)).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Exenatide in 14752 people.
With 14752 participants it is a large trial for this field.
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.