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Exenatide

CompletedPhase NAResults posted

Impact of Exenatide on Cardiovascular Exercise Performance in Type 2 Diabetes

Lead sponsor

University of Colorado, Denver

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤35•HbA1c ≤9%

Primary endpoint

•Peak Oxygen Consumption (VO2 Peak)

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 IDNCT01364584

Org study ID10-0438

Timeline

Milestones

Study first posted2011-06-02estimated

Results first posted2018-07-09actual

Last update posted2023-07-12actual

Study start2010-10 (month precision)

Primary completion2014-12actual (month precision)

Study completion2014-12actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age45 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Men and women between the ages of 45 and 70 years of age

•Diagnosed with uncomplicated type 2 diabetes

•Sedentary persons (exercising not more than one time per week)

•Females who are post-menopausal

•BMI must be less than 35

•Subjects must be taking metformin for diabetes control and may also be on sulfonylurea drugs or meglitinides

•Glycosylated hemoglobin (HbA1C) <9%

•Non-smokers or former smokers who have quit for at least 1 year

•Absence of comorbid conditions

•Resting systolic blood pressure < 190, Resting diastolic blood pressure < 95

Exclusion criteria

•People with type 2 diabetes (T2D) taking oral medications, other than metformin or sulfonylurea drugs or meglitinides, to control their diabetes.

•Persons treated with insulin will be excluded

•People who are currently smoking or have not quit for at least one year

•Peripheral neuropathy

•Regional wall motion abnormalities

•Left ventricular systolic dysfunction

•Ischemic heart disease (abnormal resting or exercise electrocardiogram)

•Presence of angina that would limit exercise performance

•Pulmonary problems that would limit exercise performance

•Systolic blood pressure >190 mmHg at rest or >250 mmHg with exercise or diastolic pressure >95 mmHg at rest or >115 mmHg with exercise

•Persons with autonomic dysfunction (>20 mm fall in upright BP without a change in heart rate)

•Proteinuria (urine protein >200 mg/dl) or a creatinine > 2.0 mg/dl

•Renal disease

•Persons with peripheral arterial disease

•Persons with a history of pancreatitis

Endpoints (15)

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

Cardiovascular outcomes

Heart failure

Cardiometabolic biomarkers

Other (unclassified)

Cardiovascular outcomes

6 endpoints

Secondary/protocol endpoint

Oxygen Uptake Kinetics Steady State Tau

Time frame:Baseline and 3 months

change from baseline, improvement

Posted result

Group	Value (mean), seconds	95% CI
Exenatide	71.4	—
Placebo	67.2	—

Secondary/protocol endpoint

Echocardiographic Measures - Circumferential Strain

Time frame:Baseline and 3 months

circumferential strain

change from baseline, improvement

Posted result

Group	Value (mean), % difference in circumferences	95% CI
Exenatide	-25.6	—
Placebo	-22.6	—

Secondary/protocol endpoint

Echocardiographic Measures - Stroke Volume

Time frame:Baseline and 3 months

stroke volume echo

change from baseline, improvement

Posted result

Group	Value (mean), mL/beat	95% CI
Exenatide	93.3	—
Placebo	80.7	—

Secondary/protocol endpoint

Echocardiographic Measures - Mitral Valve E:A Wave Velocity

Time frame:Baseline and 3 months

mitral EA ratio

change from baseline, improvement

Posted result

Group	Value (mean), centimeters/second	95% CI
Exenatide	0.85	—
Placebo	0.82	—

Secondary/protocol endpoint

Echocardiographic Measures - Mitral Valve Deceleration Time

Time frame:Baseline and 3 months

mitral deceleration time

change from baseline, improvement

Posted result

Group	Value (mean), milliseconds	95% CI
Exenatide	234.6	—
Placebo	239.8	—

Secondary/protocol endpoint

Echocardiographic Measures - Septal E:E'

Time frame:Baseline and 3 months

septal E e prime ratio

change from baseline, improvement

Posted result

Group	Value (mean), ratio	95% CI
Exenatide	8.3	—
Placebo	12.6	—

Heart failure

4 endpoints

Primary/protocol endpoint

Peak Oxygen Consumption (VO2 Peak)

Time frame:Baseline and 3 months

change from baseline, improvement

Posted result

Group	Value (mean), milliliters per kilogram per minute	95% CI
Exenatide	16.6	—
Placebo	16.1	—

Secondary/protocol endpoint

Echocardiographic Measures - Mitral Valve E Wave Velocity

Time frame:Baseline and 3 months

mitral E wave velocity

change from baseline, improvement

Posted result

Group	Value (mean), centimeters/second	95% CI
Exenatide	0.61	—
Placebo	0.78	—

Secondary/protocol endpoint

Echocardiographic Measures - Lateral E'

Time frame:Baseline and 3 months

lateral e prime

change from baseline, improvement

Posted result

Group	Value (mean), centimeters/second	95% CI
Exenatide	0.09	—
Placebo	0.09	—

Secondary/protocol endpoint

Echocardiographic Measures - Lateral E:E'

Time frame:Baseline and 3 months

lateral E e prime

change from baseline, improvement

Posted result

Group	Value (mean), ratio	95% CI
Exenatide	6.7	—
Placebo	8.4	—

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Arterial Stiffness

Time frame:Baseline and 3 months

change from baseline, improvement

Posted result

Group	Value (mean), meters/second	95% CI
Exenatide	-1.23	—
Placebo	0.37	—

Secondary/protocol endpoint

Change From Baseline in Peak Dilation of Brachial Artery Diameter

Time frame:Baseline and 3 months

change from baseline, improvement

Posted result

Group	Value (mean), millimeters	95% CI
ExenatidePre-Intervention (Baseline)	0.193	—
Post-Intervention (3 months)	0.226	—
PlaceboPre-Intervention (Baseline)	0.192	—
Post-Intervention (3 months)	0.151	—

Secondary/protocol endpoint

Echocardiographic Measures - Longitudinal Strain

Time frame:Baseline and 3 months

longitudinal strain echo

change from baseline, improvement

Posted result

Group	Value (mean), % difference in lengths	95% CI
Exenatide	-18.5	—
Placebo	-18.3	—

Secondary/protocol endpoint

Echocardiographic Measures - Septal E'

Time frame:Baseline and 3 months

septal e prime tdi

change from baseline, improvement

Posted result

Group	Value (mean), centimeters/second	95% CI
Exenatide	0.08	—
Placebo	0.07	—

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in (Non-invasively Measured) Deoxygenated Hemoglobin Concentration in the Vastus Lateralis During Exercise

Time frame:Baseline and 3 months

change from baseline, descriptive

Publications (10)

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

Are Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists Central Nervous System (CNS) Penetrant: A Narrative Review.
Neurology and therapy2025 Aug (month)PMID40172827doi:10.1007/s40120-025-00724-yvia pubmed acronym asset candidate
A double-blind, placebo-controlled trial of exenatide for the treatment of olanzapine-related weight gain in obese and overweight adults.
Journal of affective disorders2025 Aug 1PMID40203970doi:10.1016/j.jad.2025.04.046via pubmed acronym asset candidate
Exendin-4 for Parkinson's disease.
Brain circulation2021 Jan-Mar (year)PMID34084977doi:10.4103/bc.bc_21_21via pubmed acronym asset candidate
Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial.
Diabetes care2018 Feb (month)PMID29246950doi:10.2337/dc17-0417via pubmed acronym asset candidate
Glucagon-Like Peptide-1 (GLP-1) Analogues.
2012 (year)PMID31643819via pubmed acronym asset candidate
Exenatide and weight loss.
Nutrition (Burbank, Los Angeles County, Calif.)2010 Mar (month)PMID20152707doi:10.1016/j.nut.2009.07.008via pubmed acronym asset candidate
Exenatide.
Expert opinion on pharmacotherapy2007 Oct (month)PMID17931093doi:10.1517/14656566.8.15.2593via pubmed acronym asset candidate
Exenatide.
2006 (year)PMID30000037via pubmed acronym asset candidate
Exenatide.
Drugs of today (Barcelona, Spain : 1998)2005 Sep (month)PMID16341288doi:10.1358/dot.2005.41.9.893704via pubmed acronym asset candidate
Exenatide. Amylin/Eli Lilly.
Current opinion in investigational drugs (London, England : 2000)2003 Apr (month)PMID12808888via pubmed acronym asset candidate

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.