Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome

NCT02251431 · Completed

Last updated 2026-05-28

This clinical trial tests whether extended-release exenatide, compared to a placebo, is safe and effective in adults with type 2 diabetes, chronic kidney disease, and left ventricular diastolic dysfunction.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 57 people

Who can join Ages 18+ · all sexes

Timeline Started 2015-11 · est. completion 2019-12

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT02251431 ↗

Description as written by the study sponsor.

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.

Treatments tested

BYDUREON Drug

Exenatide-extended release, Cohorts A and B
Placebo also known as Matching placebo subcutaneous injection Drug

Cohort A only

Main thing measured	Galectin-3
Sponsor	Baylor Research Institute
Conditions studied	Type 2 Diabetes Mellitus, Chronic Kidney Disease, Left Ventricular Diastolic Dysfunction
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02251431 ↗