CompletedPhase 3Results posted

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

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

Lead sponsor

Baylor Research Institute

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Chronic kidney disease, Type 2 diabetes

Eligibility highlights

•HbA1c 6.6-9.9%•eGFR 50-90

Primary endpoints

•Galectin-3•ST2•NGAL

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02251431

Org study ID014-149

Secondary IDD5551L00004/ISSEXEN0013AstraZeneca

Timeline

Milestones

Study first posted2014-09-29estimated

Results first posted2023-05-17actual

Last update posted2026-02-19actual

Study start2015-11actual (month precision)

Primary completion2019-12actual (month precision)

Study completion2019-12actual (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Renal / kidney

Cardiometabolic biomarkers

Heart failure

1 endpoint

Primary/protocol endpoint

BNP

Time frame:38 weeks

NT-proBNP, change

change from baseline, improvement

Posted result

Group	Mean · pg/ml	95% CI
Exenatide-extended ReleaseBaseline	4.87	-
End of study (38th week)	5.59	-
PlaceboBaseline	9.88	-
End of study (38th week)	14.02	-

Renal / kidney

9 endpoints

Primary/protocol endpoint

NGAL

Time frame:38 weeks

ratio, improvement

Posted result

Group	Mean · ng/mmol Creat	95% CI
Exenatide-extended ReleaseBaseline	17.35	-
End of study (38th week)	14.01	-
PlaceboBaseline	18.44	-
End of study (38th week)	24.39	-

Primary/protocol endpoint

KIM-1

Time frame:38 weeks

ratio, improvement

Posted result

Group	Mean · ng/mmol Creat	95% CI
Exenatide-extended ReleaseBaseline	0.1	-
End of study (38th week)	0.13	-
PlaceboBaseline	0.13	-
End of study (38th week)	0.1	-

Primary/protocol endpoint

L-FABP

Time frame:38 weeks

ratio, improvement

Posted result

Group	Mean · ng/mmol Creat	95% CI
Exenatide-extended ReleaseBaseline	2.61	-
End of study (38th week)	2.05	-
PlaceboBaseline	3.24	-
End of study (38th week)	3	-

Primary/protocol endpoint

IL-18

Time frame:38 weeks

ratio, improvement

Posted result

Group	Mean · pg/mmol Creat	95% CI
Exenatide-extended ReleaseBaseline	1.68	-
End of study (38th week)	1.96	-
PlaceboBaseline	3.48	-
End of study (38th week)	2.68	-

Primary/protocol endpoint

Alpha GST

Time frame:38 weeks

ratio, improvement

Posted result

Group	Mean · ng/mmol Creat	95% CI
Exenatide-extended ReleaseBaseline	0.06	-
End of study (38th week)	0.05	-
PlaceboBaseline	0.67	-
End of study (38th week)	0.27	-

Primary/protocol endpoint/low confidence

Pi GST

Time frame:38 weeks

ratio, improvement

Posted result

Group	Mean · ng/mmol Creat	95% CI
Exenatide-extended ReleaseBaseline	2.2	-
End of study (38th week)	3.03	-
PlaceboBaseline	3.99	-
End of study (38th week)	4.27	-

Primary/protocol endpoint

NAG

Time frame:38 weeks

ratio, improvement

Posted result

Group	Mean · ng/mmol Creat	95% CI
Exenatide-extended ReleaseBaseline	17.35	-
End of study (38th week)	14.01	-
PlaceboBaseline	18.44	-
End of study (38th week)	24.39	-

Primary/protocol endpoint

Cystatin-C

Time frame:38 weeks

ratio, improvement

Posted result

Group	Mean · ng/mmol Creat	95% CI
Exenatide-extended ReleaseBaseline	2.07	-
End of study (38th week)	1.47	-
PlaceboBaseline	1.84	-
End of study (38th week)	1.57	-

Primary/protocol endpoint

ACR

Time frame:38 weeks

uACR, change

change from baseline, improvement

LOINC 9318-7

Posted result

Group	Mean · ng/mmol Creat	95% CI
Exenatide-extended ReleaseBaseline	6678.23	-
End of study (38th week)	3963.49	-
PlaceboBaseline	9713.65	-
End of study (38th week)	9825.2	-

Cardiometabolic biomarkers

3 endpoints

Primary/protocol endpoint

Galectin-3

Time frame:38 weeks

change from baseline, improvement

Posted result

Group	Mean · pg/ml	95% CI
Exenatide-extended ReleaseBaseline	9570.91	-
End of study (38th week)	9539.21	-
PlaceboBaseline	9266.7	-
End of study (38th week)	8098.78	-

Primary/protocol endpoint/low confidence

ST2

Time frame:38 weeks

change from baseline, improvement

Posted result

Group	Mean · pg/ml	95% CI
Exenatide-extended ReleaseBaseline	635.2	-
End of study (38th week)	524.68	-
PlaceboBaseline	443.18	-
End of study (38th week)	534.53	-

Primary/protocol endpoint

Troponin I

Time frame:38 weeks

change from baseline, improvement

Posted result

Group	Mean · pg/ml	95% CI
Exenatide-extended ReleaseBaseline	230.85	-
End of study (38th week)	238.53	-
PlaceboBaseline	415.65	-
End of study (38th week)	504.48	-

Publications (7)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Soluble ST2 as a biomarker for detecting stable heart failure with a normal ejection fraction in hypertensive patients.
Journal of cardiac failure2013 Mar (month)PMID23482076doi:10.1016/j.cardfail.2013.01.010via CT.gov background
Cardiovascular effects of glucagonlike peptide-1 agonists.
The American journal of cardiology2011 Aug 2PMID21802579doi:10.1016/j.amjcard.2011.03.046via CT.gov background
Galectin-3: a novel blood test for the evaluation and management of patients with heart failure.
Reviews in cardiovascular medicine2011 (year)PMID22249510doi:10.3909/ricm0624via CT.gov background
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 care2011 Jan (month)PMID20929995doi:10.2337/dc10-1393via CT.gov background
Assessment of nonischemic myocardial fibrosis.
Journal of the American College of Cardiology2010 Jul 6PMID20620723doi:10.1016/j.jacc.2010.02.047via CT.gov background
Curriculum in cardiology: integrated diagnosis and management of diastolic heart failure.
American heart journal2007 Feb (month)PMID17239676doi:10.1016/j.ahj.2006.10.022via CT.gov background
The fine structure of thymoma, with emphasis on its differential diagnosis. A study of ten cases.
The American journal of pathology1975 Oct (month)PMID1080957via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.