Current partner codePEPTIDESDE
NCT02251431·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

57

Locations

1

Results

Posted

Publications

7

Study summary

What the protocol is testing.

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.

Full 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 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).

Interventions

Treatment arms and agents.

DRUG

BYDUREON

Exenatide-extended release, Cohorts A and B

DRUG

Placebo

Cohort A only

Timeline

From registration to results.

  1. First posted

    Sep 29, 2014

  2. Study start

    Nov 2015

  3. Primary completion

    Dec 2019

  4. Study completion

    Dec 2019

  5. Results posted

    May 17, 2023

  6. Registry updated

    Feb 19, 2026

Outcomes

What the study measures.

Primary outcomes

Galectin-3

Time frame · 38 weeks

Mean change in plasma galectin-3 (pg/ml)

ST2

Time frame · 38 weeks

Mean change in plasma ST2 (pg/ml)

NGAL

Time frame · 38 weeks

Mean change in urine neutrophil gelatinase associated lipocalin (NGAL):creatinine (Cr) ratio

KIM-1

Time frame · 38 weeks

Mean change in urine kidney injury molecule-1 (KIM-1):Cr ratio

L-FABP

Time frame · 38 weeks

Mean change in urine L-type fatty acid binding protein:Cr ratio

IL-18

Time frame · 38 weeks

Mean change in urine interleukin-18:Cr ratio

Alpha GST

Time frame · 38 weeks

Mean change in urine alpha glutathione S-transferase (αGST):Cr ratio

Troponin I

Time frame · 38 weeks

Mean change in plasma ultrasensitive troponin I (pg/ml)

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Baylor Scott and White Research Institute- Baylor Heart and Vascular Hospital

Dallas, Texas, United States

Publications

Results and literature.

PMID 17239676Chinnaiyan 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.PMID 21802579Davidson 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.PMID 1080957Levine 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.PMID 20929995Best 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.PMID 22249510McCullough 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.PMID 23482076Wang 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.PMID 20620723Jellis 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.

Primary links

Continue at the source.

Related trials

More studies on Exenatide.

Related PeptideStat pages

Put the record in context.

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