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Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure
Plain-language guide to NCT00799435: phase 4 randomized trial of Exenatide, 2 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00799435
- Phase
- phase 4
- Status
- terminated early
- Start
- 2009-07
- Completion (planned or actual)
- 2012-04
- Participants
- 2 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2; Heart Failure, Diastolic
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Exenatide.
It had two arms (groups): 1 (no intervention) and 2 (experimental).
Participants will receive exenatide for 12 weeks.
The registry classes the interventions as drug.
More on the Plan
Participants will then be randomly assigned to receive either exenatide or usual care.
All participants will attend a study visit at Week 12 for repeat baseline testing.
Who Took Part
2 actual participants took part.
It was open to people of any sex aged from 30 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 2 diabetes.
The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: angina with exertion; technically inadequate echocardiogram; atrial fibrillation or atrial flutter.
How the Study Was Run
Design: randomized, parallel-group and open-label.
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.
Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2009-07 with completion listed for 2012-04.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in Aortic Stiffness, as Measured by the Change in the Mean Aortic Pulse Wave Velocity (time frame: Measured at Week 12).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Exenatide in 2 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); 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.