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

Exclusion Criteria

• •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
• •Prior bariatric surgery