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NCT Number: NCT02251431

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Cardiovascular Diseases Chronic Disease Chronic Kidney Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Heart Diseases Kidney Diseases Left Ventricular Diastolic Dysfunction Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Dallas, Texas, 75226, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bydureon

Drug

Exenatide-extended release, Cohorts A and B

Placebo

Drug

Cohort A only

Other names: Matching placebo subcutaneous injection

Primary outcomes

  1. Galectin-3

    Time frame: 38 weeks

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

  2. ST2

    Time frame: 38 weeks

    Mean change in plasma ST2 (pg/ml)

  3. NGAL

    Time frame: 38 weeks

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

  4. KIM-1

    Time frame: 38 weeks

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

  5. L-FABP

    Time frame: 38 weeks

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

  6. IL-18

    Time frame: 38 weeks

    Mean change in urine interleukin-18:Cr ratio

  7. Alpha GST

    Time frame: 38 weeks

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

  8. Troponin I

    Time frame: 38 weeks

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

  9. Pi GST

    Time frame: 38 weeks

    Mean change in pi glutathione S-transferase (piGST):Cr ratio

  10. NAG

    Time frame: 38 weeks

    Mean change in urine N-acetyl-β-D-glucosaminidase (NAG):Cr ratio

  11. Cystatin-C

    Time frame: 38 weeks

    Mean paired change in urine cystatin-C:Cr ratio (uCysC:Cr)

  12. BNP

    Time frame: 38 weeks

    Mean change in plasma B-type natriuretic peptide BNP (pg/ml)

  13. ACR

    Time frame: 38 weeks

    Mean change in urine albumin:Cr ratio (ACR)

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 29, 2014
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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