Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome
NCT ID: NCT02251431
Last Updated: 2023-05-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
57 participants
INTERVENTIONAL
2015-11-30
2019-12-31
Brief Summary
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Detailed Description
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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 evaluate the quantitative impact on the MISS (myocardial injury summary score) cardiac biomarker score, cardiac fibrosis by MRI, cardiac strain by ultrasonography and strain rate imaging, and KISS (kidney injury summary score) kidney biomarker score after 38 weeks of treatment with exenatide extended-release or placebo.
Secondary Aim
To evaluate the inter-relationships between demographic, clinical, and biochemical variables (MISS score, KISS score) and of progressive cardiac fibrosis as assessed by MRI, strain-rate imaging, and in adult individuals with T2DM and at risk for DHF (Type 4 cardiorenal syndrome).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Exenatide-extended release
Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks
BYDUREON
Exenatide-extended release, Cohorts A and B
Placebo
Matching placebo subcutaneously once per week x 38 weeks
Placebo
Cohort A only
Interventions
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BYDUREON
Exenatide-extended release, Cohorts A and B
Placebo
Cohort A only
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Baylor Research Institute
OTHER
Responsible Party
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Principal Investigators
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Peter A McCullough, MD, MPH
Role: STUDY_CHAIR
Baylor Research Institute
Locations
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Baylor Scott and White Research Institute- Baylor Heart and Vascular Hospital
Dallas, Texas, United States
Countries
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References
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Chinnaiyan KM, Alexander D, Maddens M, McCullough PA. Curriculum in cardiology: integrated diagnosis and management of diastolic heart failure. Am Heart J. 2007 Feb;153(2):189-200. doi: 10.1016/j.ahj.2006.10.022.
Davidson MH. Cardiovascular effects of glucagonlike peptide-1 agonists. Am J Cardiol. 2011 Aug 2;108(3 Suppl):33B-41B. doi: 10.1016/j.amjcard.2011.03.046.
Levine GD, Rosai J, Bearman RM, Polliack A. The fine structure of thymoma, with emphasis on its differential diagnosis. A study of ten cases. Am J Pathol. 1975 Oct;81(1):49-86.
Best JH, Hoogwerf BJ, Herman WH, Pelletier EM, Smith DB, Wenten M, Hussein MA. Risk of cardiovascular disease events in patients with type 2 diabetes prescribed the glucagon-like peptide 1 (GLP-1) receptor agonist exenatide twice daily or other glucose-lowering therapies: a retrospective analysis of the LifeLink database. Diabetes Care. 2011 Jan;34(1):90-5. doi: 10.2337/dc10-1393. Epub 2010 Oct 7.
McCullough PA, Olobatoke A, Vanhecke TE. Galectin-3: a novel blood test for the evaluation and management of patients with heart failure. Rev Cardiovasc Med. 2011;12(4):200-10. doi: 10.3909/ricm0624.
Wang YC, Yu CC, Chiu FC, Tsai CT, Lai LP, Hwang JJ, Lin JL. Soluble ST2 as a biomarker for detecting stable heart failure with a normal ejection fraction in hypertensive patients. J Card Fail. 2013 Mar;19(3):163-8. doi: 10.1016/j.cardfail.2013.01.010.
Jellis C, Martin J, Narula J, Marwick TH. Assessment of nonischemic myocardial fibrosis. J Am Coll Cardiol. 2010 Jul 6;56(2):89-97. doi: 10.1016/j.jacc.2010.02.047.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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D5551L00004/ISSEXEN0013
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
014-149
Identifier Type: -
Identifier Source: org_study_id
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