MB001-067 A PROSPECTIVE, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, RANDOMIZED TRIAL OF EXTENDED RELEASE EXENATIDE VERSUS PLACEBO (COHORT A) AND A PROSPECTIVE, SINGLE GROUP, OPEN-LABEL, BLINDED OUTCOME TRIAL OF EXTENDED RELEASE EXENATIDE (COHORT B) IN DIABETIC PATIENTS WITH TYPE 4 CARDIORENAL SYNDROME (EXTEND-CRS TRIAL) AMENDMENT 3

014-149

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.

2015-11-01

2019-12-01

2019-12-01

Completed

Early phase I

57

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

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2023-05-17