GLP-1 Peptide Atlas, by Delfa

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CompletedPhase 4

Exenatide Once Weekly, Cardiovascular Risk and Type-2 Diabetes

Effect of Exenatide Once Weekly on Cardiovascular Risk Markers in Patients With Type-2 Diabetes

Lead sponsor

University of Palermo

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥25•HbA1c 7.5-8.5%

Primary endpoint

•Subclinical atherosclerosis

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 IDNCT02380521

Org study IDESR-14-10139

Timeline

Milestones

Study first posted2015-03-05estimated

Last update posted2016-11-08estimated

Study start2015-01 (month precision)

Primary completion2016-07actual (month precision)

Study completion2016-11actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Provision of informed consent prior to any study specific procedures;

2. Men and women with T2DM aged >18 years;

3. BMI >25 kg/m2;

4. HbA1c 7.5-8.5 %;

5. Receiving metformin therapy (doses ranging from 1500 to 3000 mg daily) for at least 8 weeks.

Exclusion criteria

1. Pregnancy or willingness to become pregnant;

2. Moderate and severe liver dysfunction;

3. Moderate and severe renal failure;

4. Previous major cardiovascular event;

5. Severe infections at the discretion of the investigator (such as human immunodeficiency virus [HIV], hepatitis B virus [HBV] and hepatitis C virus [HCV]);

6. Any malignancy;

7. Plasma triglycerides >400 mg/dL, plasma LDL-cholesterol > 250 mg/dL.

Endpoints (4)

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

Other (unclassified)

Cardiometabolic biomarkers

3 endpoints

Primary/protocol endpoint

Subclinical atherosclerosis (as measured by cIMT) in patients with T2DM treated with exenatide once weekly

Time frame:Change from baseline to 8 months of the treatment

change from baseline, improvement

Secondary/protocol endpoint

Atherogenic lipoproteins (as measured by the analysis of 11 distinct lipoprotein subclasses using the Lipoprint system®) in patients with T2DM treated with exenatide once weekly

Time frame:Change from baseline to 8 months of the treatment

change from baseline, improvement

Secondary/protocol endpoint

Endothelial dysfunction (as measured by flow mediated dilation of brachial artery) in patients with T2DM treated with exenatide once weekly

Time frame:Change from baseline to 8 months of the treatment

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Oxidative stress (as measured by markers of oxidative stress) in patients with T2DM treated with exenatide once weekly

Time frame:Change from baseline to 8 months of the treatment

change from baseline, improvement

Publications (6)

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

Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study.
Lancet (London, England)2013 Jan 12PMID23141817doi:10.1016/S0140-6736(12)61267-7via CT.gov background
Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study.
Diabetes care2012 Feb (month)PMID22210563doi:10.2337/dc11-1107via CT.gov background
DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes.
The Journal of clinical endocrinology and metabolism2011 May (month)PMID21307137doi:10.1210/jc.2010-2081via CT.gov background
Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial.
Lancet (London, England)2010 Aug 7PMID20580422doi:10.1016/S0140-6736(10)60590-9via CT.gov background
Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial.
Lancet (London, England)2010 Jun 26PMID20609969doi:10.1016/S0140-6736(10)60406-0via CT.gov background
Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study.
Lancet (London, England)2008 Oct 4PMID18782641doi:10.1016/S0140-6736(08)61206-4via CT.gov background

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.