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TerminatedPhase 4Results posted

Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure

Treatment With Glucagon-Like Peptide-1 Receptor, Exenatide, in Patients With Diabetes and Heart Failure With Normal Left Ventricular Ejection Fraction

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

2

actual

Study population

Heart failure, Type 2 diabetes

Key I/E criterion

Primary endpoint

Aortic Stiffness

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00799435
Org study ID613
Secondary ID1K01HL092585
Secondary ID1K01HL092585-01
Secondary IDH-22906Baylor College of Medicine

Timeline

Milestones

Study first posted2008-11-27estimated
Results first posted2017-09-21actual
Last update posted2020-09-04actual
Study start2009-07 (month precision)
Primary completion2012-04actual (month precision)
Study completion2012-04actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Heart failureType 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Stable New York Heart Association (NYHA) Class II-IV heart failure symptoms for at least 4 weeks before study entry
Diagnosis of diastolic heart failure with a normal ejection fraction
Admitted to the hospital with a diagnosis of heart failure in the 12 months before study entry
Type 2 diabetes

Exclusion criteria

Unstable angina, heart attack, coronary artery bypass surgery, or angioplasty in the 3 months before study entry
Angina with exertion
Technically inadequate echocardiogram
Atrial fibrillation or atrial flutter
Severe valvular heart disease
Significant kidney insufficiency (serum creatinine greater than 2.0 mg/dL or require hemodialysis)
Conditions that may be associated with changes in markers of fibrosis or collagen turnover (e.g., ongoing or active rheumatological disease, requiring significant anti-inflammatory agents, immunosuppression, pulmonary fibrosis, active cancer)
Significant history of active substance abuse
Type 1 diabetes
Type 2 diabetes requiring chronic insulin use before study entry
Active thiazolidinedione (TZD) use, because TZDs have been shown to worsen volume retention and may exacerbate signs and/or symptoms of heart failure
Pregnant or breastfeeding
Hypertrophic cardiomyopathy

Endpoints (2)

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

Cardiometabolic biomarkers
1
Other (unclassified)
1

Cardiometabolic biomarkers

1 endpoint
Primary/protocol endpoint

Change in Aortic Stiffness, as Measured by the Change in the Mean Aortic Pulse Wave Velocity

Time frame:Measured at Week 12

change from baseline, improvement

Posted result

GroupValue (mean), m/sec95% CI
Usual CareBaseline Pulse Wave Velocity11.4
Follow-up Pulse Wave VelocityNA
ExenatideBaseline Pulse Wave Velocity9.3
Follow-up Pulse Wave Velocity10.2

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Changes in Left Ventricular Diastolic Stiffness, Serum Levels of Advanced Glycation End Products, Serum Biomarkers of Collagen Synthesis, and Serum Levels of Brain Natriuretic Peptide

Time frame:Measured at Week 12

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.