Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome
Completed · Phase 3 · Has a placebo group
Conditions studied: Type 2 Diabetes Mellitus, Chronic Kidney Disease, Left Ventricular Diastolic Dysfunction
In brief
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.
Key facts
- Study ID
- NCT02251431
- Run by
- Baylor Research Institute
- People needed
- 57
- Starts
- 2015-11-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2026-02-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18
- Type 2 diabetes mellitus with hemoglobin A1C 6.6-9.9% with or without the use of insulin
- Estimated glomerular filtration rate (eGFR) between 50 and 90 ml/min/1.73 m2
You may not qualify if…
- 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
- eGFR < 50 ml/min/1.73 m2
- eGFR > 90 ml/min/1.73 m2
- Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. BYETTA™ (exenatide), BYDUREON™ (Exenatide extended-release), VICTOZA™ (liraglutide), or taspoglutide
- Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
- Disorders of iron metabolism
- Collagen vascular diseases
- Myocardial infarction
- Use of DDP4 inhibitors, and PPAR gamma agonists
- Pregnancy or planned pregnancy during the trial period
- Hemoglobin A1C of ≥ 10.0% or <6.6%
- Fasting glucose ≥ 260 mg/dl
- Clinically significant abnormal baseline laboratories
- Morbid obesity or body girth that prohibits the ability to undergo echocardiography or MRI scanning with high-quality image results
- Renal transplantation
- Severe gastrointestinal, liver, or neurodegenerative disease
- Decompensated liver cirrhosis (Child-Pugh score >7)
- New York Heart Association Class III or IV heart failure
- Patients have alanine aminotransaminase (ALT) greater than 5 times the upper limit of the reference range.
- Prior pancreatitis
- Personal or family history of medullary thyroid adenoma or carcinoma (MTC)
- Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- History of severe hypoglycemia
Where it is running
- Baylor Scott and White Research Institute- Baylor Heart and Vascular Hospital — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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