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NCT02251431 · ClinicalTrials.gov registry record · Phase 3
Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome
A Phase 3 study of Type 2 Diabetes Mellitus and Chronic Kidney Disease, sponsored by Baylor Research Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT02251431: Completed Phase 3 study of Type 2 Diabetes Mellitus and Chronic Kidney Disease, sponsored by Baylor Research Institute.
NCT02251431 is a Phase 3 study of Type 2 Diabetes Mellitus and Chronic Kidney Disease that has completed, run by Baylor Research Institute. The registered enrollment target is 57 participants, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02251431, a Phase 3 study of Type 2 Diabetes Mellitus and Chronic Kidney Disease, has completed, sponsored by Baylor Research Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
Among adult individuals with type 2 diabetes mellitus and at risk for heart failure with impaired relaxation of the heart mildly reduced kidney filtration function (Type 4 cardiorenal syndrome) this trial will evaluate the quantitative impact of 38 weeks of treatment with exenatide extended-release injections versus placebo. on a cardiac biomarker blood test score, cardiac fibrosis seen on magnetic resonance scanning, cardiac strain identified by ultrasonography and strain rate imaging, and a kidney urine biomarker score.
Primary Outcome
Mean change in plasma galectin-3 (pg/ml)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BYDUREON
Study Locations (1)
Texas
- Baylor Scott and White Research Institute- Baylor Heart and Vascular Hospital - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2015-11 |
| Est. Completion | 2019-12 |
| Phase | Phase 3 |
What the finished NCT02251431 record still lists
NCT02251431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02251431 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02251431 about?
NCT02251431 is a clinical study titled "Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome". Among adult individuals with type 2 diabetes mellitus and at risk for heart failure with impaired relaxation of the heart mildly reduced kidney filtration function (Type 4 cardiorenal syndrome) this trial will evaluate the quantitative impact of 38 weeks of treatment with exenatide extended-release ...
What is the current status of trial NCT02251431?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 57 participants. The study started on 2015-11. Estimated completion is 2019-12.
What conditions does trial NCT02251431 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus, Chronic Kidney Disease, Left Ventricular Diastolic Dysfunction.
What interventions are being tested in trial NCT02251431?
The interventions under investigation include: Placebo (DRUG), BYDUREON (DRUG).
Who is sponsoring clinical trial NCT02251431?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02251431 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02251431's enrollment target sits among peer trials
57 76th of 130 higher than 54 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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