Phase 3 · Exenatide

NCT02251431 trial results

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

Participants
57
Status
completed
Completed
2019-12
Sponsor
Baylor Research Institute

As posted on ClinicalTrials.gov (NCT02251431), updated at source Feb 19, 2026. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT02251431 measured first

Galectin-3pg/ml · 38 weeks · mean
MeasureExenatide-extended Releasen=29Placebon=28
Baseline9570.91(4990.06)9266.7(6032.8)
End of study (38th week)9539.21(3893.04)8098.78(6272.55)
ST2pg/ml · 38 weeks · mean
MeasureExenatide-extended Releasen=29Placebon=28
Baseline635.2(449.82)443.18(380.34)
End of study (38th week)524.68(423.61)534.53(302.89)
NGALng/mmol Creat · 38 weeks · mean
MeasureExenatide-extended Releasen=29Placebon=28
Baseline17.35(29.01)18.44(25.01)
End of study (38th week)14.01(14.87)24.39(40.37)
KIM-1ng/mmol Creat · 38 weeks · mean
MeasureExenatide-extended Releasen=29Placebon=28
Baseline0.1(0.08)0.13(0.09)
End of study (38th week)0.13(0.14)0.1(0.05)
L-FABPng/mmol Creat · 38 weeks · mean
MeasureExenatide-extended Releasen=29Placebon=28
Baseline2.61(3.72)3.24(4.17)
End of study (38th week)2.05(2.18)3(2.85)
IL-18pg/mmol Creat · 38 weeks · mean
MeasureExenatide-extended Releasen=29Placebon=28
Baseline1.68(2.4)3.48(4.69)
End of study (38th week)1.96(3.5)2.68(2.48)
Alpha GSTng/mmol Creat · 38 weeks · mean
MeasureExenatide-extended Releasen=29Placebon=28
Baseline0.06(0.2)0.67(1.83)
End of study (38th week)0.05(0.16)0.27(0.56)
Troponin Ipg/ml · 38 weeks · mean
MeasureExenatide-extended Releasen=29Placebon=28
Baseline230.85(282.73)415.65(446.33)
End of study (38th week)238.53(283.59)504.48(599.4)
Pi GSTng/mmol Creat · 38 weeks · mean
MeasureExenatide-extended Releasen=29Placebon=28
Baseline2.2(3.41)3.99(3.96)
End of study (38th week)3.03(5.67)4.27(4.67)
NAGng/mmol Creat · 38 weeks · mean
MeasureExenatide-extended Releasen=29Placebon=28
Baseline17.35(29.01)18.44(25.01)
End of study (38th week)14.01(14.87)24.39(40.37)
Cystatin-Cng/mmol Creat · 38 weeks · mean
MeasureExenatide-extended Releasen=29Placebon=28
Baseline2.07(2.64)1.84(1.19)
End of study (38th week)1.47(1.22)1.57(1.17)
BNPpg/ml · 38 weeks · mean
MeasureExenatide-extended Releasen=29Placebon=28
Baseline4.87(9.3)9.88(14.52)
End of study (38th week)5.59(9.59)14.02(22.53)
ACRng/mmol Creat · 38 weeks · mean
MeasureExenatide-extended Releasen=29Placebon=28
Baseline6678.23(12662.79)9713.65(14380.38)
End of study (38th week)3963.49(3101.13)9825.2(9539.34)
Side effects by arm

Side effects in NCT02251431

Percent of participants affected, 38 weeks from study initiation. The most common events the registry lists.

EventExenatide-extended ReleasePlacebo
Any serious event0%3.6%
Gastrointestinal events, myalgia, fatigue69%75%
Injection site reaction51.7%35.7%
The trial

How NCT02251431 was run

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.

  • Exenatide-extended release: Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks
  • Placebo: Matching placebo subcutaneously once per week x 38 weeks
Who could join the trial

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

Published papers

Papers from NCT02251431

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.