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

• Status: Completed
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor Research Institute
• Treatments: Exenatide

Criteria

Inclusion Criteria:

• 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

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