Status:
COMPLETED
Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome
Lead Sponsor:
Baylor Research Institute
Conditions:
Type 2 Diabetes Mellitus
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 t...
Detailed Description
Primary Aim Among adult individuals with type 2 diabetes mellitus (T2DM) and at risk for diastolic heart failure (DHF) and mildly reduced renal filtration function (Type 4 cardiorenal syndrome), to e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT02251431
Start Date
November 1 2015
End Date
December 1 2019
Last Update
May 17 2023
Active Locations (1)
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1
Baylor Scott and White Research Institute- Baylor Heart and Vascular Hospital
Dallas, Texas, United States, 75226