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Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome
Plain-language guide to NCT02251431: phase 3 randomized trial of Exenatide, 57 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02251431
- Phase
- phase 3
- Status
- completed
- Start
- 2015-11
- Completion (planned or actual)
- 2019-12
- Participants
- 57 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Type 2 Diabetes Mellitus; Chronic Kidney Disease; Left Ventricular Diastolic Dysfunction
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Exenatide.
It had two arms (groups): Exenatide-extended release (experimental) and Placebo (placebo comparator).
Matching placebo subcutaneously once per week x 38 weeks.
The registry classes the interventions as drug.
More on the Plan
Secondary Aim To evaluate the inter-relationships between demographic, clinical, and biochemical variables (MISS score, KISS score) and of progressive cardiac fibrosis as assessed by MRI, strain-rate imaging, and in adult individuals with T2DM and at risk for DHF (Type 4 cardiorenal syndrome).
Who Took Part
57 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: Age ≥ 18.
The full record lists 3 inclusion and 26 exclusion criteria; among the exclusions: allergy or intolerance to gadolinium; implanted cardiac pacemaker, defibrillator, loop recorder, or other implanted metallic device; any other metallic implanted device that is a contra-indication to mri scanning.
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.
The Exenatide group and the comparison group ran side by side rather than switching.
As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2015-11 with completion listed for 2019-12.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Galectin-3 (time frame: 38 weeks). ST2 (time frame: 38 weeks). NGAL (time frame: 38 weeks).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Exenatide in 57 people.
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.