Type 2 Diabetes MellitusPhase 3NCT02251431

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

A Phase 3 study testing BYDUREON in people with Type 2 Diabetes Mellitus and Chronic Kidney Disease, run by Baylor Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus, Chronic Kidney Disease, Left Ventricular Diastolic Dysfunction
What is being tested?: BYDUREON
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 1 siteUnited States
Study dates: Nov 2015to Dec 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 26Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Baylor Scott and White Research Institute- Baylor Heart and Vascular Hospital
Dallas, Texas, 75226

Other trials in United States

About this study

Official 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

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.

Read the 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).

Conditions: Type 2 Diabetes Mellitus, Chronic Kidney Disease, Left Ventricular Diastolic Dysfunction
Being tested: BYDUREON, Placebo
Keywords: diabetes mellitus, chronic kidney disease, diastolic function, cardiac fibrosis, cardiac strain, cardiac biomarker, renal biomarker
Medical subject headings: Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Ventricular Dysfunction, Left, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BYDUREONDrug
Exenatide-extended release, Cohorts A and B
PlaceboDrug
Also called Matching placebo subcutaneous injection
Cohort A only

Study groups in NCT02251431
Study group	Role	What they receive
Exenatide-extended release	Experimental	Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks Receives: Drug: BYDUREON
Placebo	Placebo comparator	Matching placebo subcutaneously once per week x 38 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Galectin-3
Mean change in plasma galectin-3 (pg/ml)
Measured: 38 weeks
ST2
Mean change in plasma ST2 (pg/ml)
Measured: 38 weeks
NGAL
Mean change in urine neutrophil gelatinase associated lipocalin (NGAL):creatinine (Cr) ratio
Measured: 38 weeks
KIM-1
Mean change in urine kidney injury molecule-1 (KIM-1):Cr ratio
Measured: 38 weeks
L-FABP
Mean change in urine L-type fatty acid binding protein:Cr ratio
Measured: 38 weeks
IL-18
Mean change in urine interleukin-18:Cr ratio
Measured: 38 weeks
Alpha GST
Mean change in urine alpha glutathione S-transferase (αGST):Cr ratio
Measured: 38 weeks
Troponin I
Mean change in plasma ultrasensitive troponin I (pg/ml)
Measured: 38 weeks
Pi GST
Mean change in pi glutathione S-transferase (piGST):Cr ratio
Measured: 38 weeks
NAG
Mean change in urine N-acetyl-β-D-glucosaminidase (NAG):Cr ratio
Measured: 38 weeks
Cystatin-C
Mean paired change in urine cystatin-C:Cr ratio (uCysC:Cr)
Measured: 38 weeks
BNP
Mean change in plasma B-type natriuretic peptide BNP (pg/ml)
Measured: 38 weeks
ACR
Mean change in urine albumin:Cr ratio (ACR)
Measured: 38 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Dec 2019

First posted29 Sep 2014 (estimated)
Study startNov 2015
Primary completionDec 2019
Study completionDec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Baylor Research InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02251431
Sponsor's protocol ID: 014-149
Other IDs: D5551L00004/ISSEXEN0013
Status last verified: Jun 2020
First submitted: 12 Sep 2014
Last updated: 19 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 17239676
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.
PubMed 21802579
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.
PubMed 1080957
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.
PubMed 20929995
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.
PubMed 22249510
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.
PubMed 23482076
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.
PubMed 20620723

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT02251431
Acronym / sponsor ID: 014-149
Conditions: Type 2 Diabetes Mellitus, Chronic Kidney Disease, Left Ventricular Diastolic Dysfunction
Keywords: diabetes mellitus, chronic kidney disease, diastolic function, cardiac fibrosis, cardiac strain, cardiac biomarker, renal biomarker
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Baylor Research InstituteUniversity, hospital or other
Study start: Nov 2015 (actual)
Primary completion: Dec 2019 (actual)
Study completion: Dec 2019 (actual)
First posted: 29 Sep 2014 (estimated)
Results: Posted 17 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary Aim

Secondary Aim

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Exenatide-extended release	Experimental	Drug: BYDUREONExenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks
Placebo	Placebo comparator	Drug: PlaceboMatching placebo subcutaneously once per week x 38 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (26 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BYDUREONExenatide-extended release, Cohorts A and B	Drug	Exenatide-extended release
PlaceboAlso: Matching placebo subcutaneous injectionCohort A only	Drug	Placebo

Primary outcome

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)
Pi GST
Time frame: 38 weeks
Mean change in pi glutathione S-transferase (piGST):Cr ratio
NAG
Time frame: 38 weeks
Mean change in urine N-acetyl-β-D-glucosaminidase (NAG):Cr ratio
Cystatin-C
Time frame: 38 weeks
Mean paired change in urine cystatin-C:Cr ratio (uCysC:Cr)
BNP
Time frame: 38 weeks
Mean change in plasma B-type natriuretic peptide BNP (pg/ml)
ACR
Time frame: 38 weeks
Mean change in urine albumin:Cr ratio (ACR)

Results and safety

Results posted to the registry on 17 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exenatide-extended Release	29	29
Placebo	28	28

Primary outcome: Galectin-3

Time frame: 38 weeks. Mean (Standard Deviation). Unit: pg/ml

Measure	Exenatide-extended Release n = 29	Placebo n = 28
Baseline	9570.91 (4990.06)	9266.7 (6032.8)
End of study (38th week)	9539.21 (3893.04)	8098.78 (6272.55)

Primary outcome: ST2

Time frame: 38 weeks. Mean (Standard Deviation). Unit: pg/ml

Measure	Exenatide-extended Release n = 29	Placebo n = 28
Baseline	635.2 (449.82)	443.18 (380.34)
End of study (38th week)	524.68 (423.61)	534.53 (302.89)

Primary outcome: NGAL

Time frame: 38 weeks. Mean (Standard Deviation). Unit: ng/mmol Creat

Measure	Exenatide-extended Release n = 29	Placebo n = 28
Baseline	17.35 (29.01)	18.44 (25.01)
End of study (38th week)	14.01 (14.87)	24.39 (40.37)

Primary outcome: KIM-1

Time frame: 38 weeks. Mean (Standard Deviation). Unit: ng/mmol Creat

Measure	Exenatide-extended Release n = 29	Placebo n = 28
Baseline	0.1 (0.08)	0.13 (0.09)
End of study (38th week)	0.13 (0.14)	0.1 (0.05)

Adverse events

Time frame: 38 weeks from study initiation. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exenatide-extended Release	0 of 29 (0%)	20 of 29 (69%)	0 of 29
Placebo	1 of 28 (3.6%)	21 of 28 (75%)	0 of 28

Limitations and caveats (from the sponsor): Our recruitment stopped early due to low accrual rate. Hence, null findings may be a result of lack of statistical power. Accordingly, our results should be interpreted as hypothesis-generating.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 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.
Background: PubMed 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.
Background: PubMed 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.
Background: PubMed 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.
Background: PubMed 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.
Background: PubMed 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.
Background: PubMed 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter A McCullough, MD, MPH study chair

Baylor Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BYDUREON in people with Type 2 Diabetes Mellitus and Chronic Kidney Disease, run by Baylor Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Galectin-3 (time frame: 38 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02251431, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.