DelfaGLP-1 Atlas

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CompletedPhase 4

Effects of Exenatide in Type 2 Diabetic Patients With Congestive Heart Failure

The Effect of Exenatide Compared to Insulin Glargine on Cardiac Function and Metabolism in Type 2 Diabetic Patients With Congestive Heart Failure: a Randomized Comparator-controlled Trial

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

27

actual

Study population

Heart failure, Type 2 diabetes

Key I/E criteria

•HbA1c 6.5-10%•EF ≤50%

Primary endpoint

•Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function

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 IDNCT00766857
Org study IDDC2008exe001
Secondary IDEudraCT: 2008-005325-10

Timeline

Milestones

Study first posted2008-10-06estimated
Last update posted2015-12-09estimated
Study start2009-05 (month precision)
Primary completion2012-12actual (month precision)
Study completion2012-12actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Heart failureType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Type 2 diabetes mellitus
•Male and postmenopausal female
•Age 18 years an above
•Metformin therapy (stable, maximum tolerable dose for 2 months)
•HbA1c 6.5-10%
•Confirmed congestive heart failure (NHYA functional class II-IV)
•Ejection fraction < 50%
•Patients should receive a stable standard therapy for their cardiac condition for 3 months prior entering the study

Exclusion criteria

•Type 1 diabetes mellitus
•Serious renal or liver impairment
•(Receiving treatment for) malignant disease
•Cardiovascular event < 3 months prior to inclusion
•Acute congestive heart failure
•Any reason for not being able to sustain the imaging studies
•Pacemaker/ICD
•Contraindications for the use of exenatide/ insulin
•Use of insulin, thiazolidinediones, incretin-based therapies within 4 months of screening
•Chronic use of glucocorticoids, NSAIDs or centrally acting drugs (> 2 weeks) within 2 weeks immediately prior to screening

Endpoints (5)

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

Other (unclassified)
3
Heart failure
2

Heart failure

2 endpoints
Primary/protocol endpoint/low confidence

Cardiac Magnetic Resonance (CMR) will be used to assess global cardiac function (LV ejection fraction).

Time frame:week -2 and week 11

change from baseline, improvement

Secondary/protocol endpoint

Exercise capacity and performance will be assessed by a 6-minute walking test

Time frame:week -1 and week 27

6-minute walk distance

change from baseline, improvement

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Cardiac oxygen consumption, cardiac efficiency and stress perfusion will be assessed by Positron Emission Tomography (PET) using 11C-acetate and H2-15O

Time frame:week -2 and week 26

descriptive

Secondary/protocol endpoint/low confidence

Cardiac function, dimensions and scarring will be measured bij CMR

Time frame:week -2 and week 26

descriptive

Secondary/protocol endpoint/low confidence

Myocardial diastolic function parameters will be obtained bij trans thoracal echocardiography. Comparisons will be made of strain and torsion measures obtained bij CMR and echocardiography.

Time frame:week -2 and week 26

descriptive

Publications (1)

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.