DelfaGLP-1 Atlas

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CompletedPhase 4

Effects on Re-endothelialisation With Bydureon Treatment in Type 2 Diabetes Subjects

Effects on Re-endothelialisation With Bydureon Treatment Add on to Insulin Versus Insulin Alone, Both in Combination With Metformin in Type 2 Diabetic Subjects

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

38

actual

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Degree of non-covered stent struts by Bydureon add on to Insulin over that

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 IDNCT02621489
Org study IDBY2015

Timeline

Milestones

Study first posted2015-12-03estimated
Last update posted2023-04-20actual
Study start2015-12 (month precision)
Primary completion2022-08actual (month precision)
Study completion2022-10actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Patients eligible for PCI with application of DES, due to ACS.

2. Patients with known or newly diagnosed T2D (type 2 diabetes is diagnosed according to current WHO criteria or by the use of anti-diabetic drugs)

3. Male and female subjects 18-80 years.

4. HbA1c (accordingly to IFCC) 47 mmol/mol - 110 mmol/mol.

5. Signed informed consent form.

Exclusion criteria

1. Type 1 diabetes (autoantibody positive).

2. Any history of receiving GLP-1 analogues or dipeptidyl peptidase inhibitors within 6 months

3. Known severe heart failure, classified as NYHA 4.

4. Active myocarditis; malfunctioning artificial heart valve.

5. History of ventricular tachycardia within 3 months before study entry; second- or third-degree atrioventricular block.

6. Supine systolic blood pressure <85 mm Hg or >200 mm Hg at screening.

7. Primary renal impairment, creatinine clearance < 45 ml/min if treated with metformin.

8. Uncorrected hypokalemia or hyperkalemia (potassium <3.5 mmol/l or >5.5 mmol/l).

9. Significant anemia (Hb < 90 g/l)

10. Severe gastrointestinal disease, including gastroparesis. As judged by the Investigator.

11. Body mass index (BMI) > 45 kg/m2.

12. Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years. Patients with intraepithelial squamous cell carcinoma of the skin treated with topical 5FU and subjects with basal cell skin cancer are allowed to enter the trial.

13. Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant.

14. Current drug and alcohol abuse.

15. History of acute or chronic pancreatitis

16. Subjects considered by the Investigator to be unsuitable for the study.

Endpoints (16)

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
6
Other (unclassified)
6
Cardiometabolic biomarkers
4

Cardiovascular outcomes

6 endpoints
Primary/protocol endpoint/low confidence

The degree of non-covered stent struts by Bydureon add on to Insulin over that of Insulin as analyzed by optical coherence tomography (OCT).

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Fractional flow reserve positive re-stenosis

Time frame:12 weeks

categorical status, event

Secondary/protocol endpoint

Target lesion failure

Time frame:12 weeks

Coronary revascularization

time to event, event

SNOMED 415070008

Secondary/protocol endpoint

Acute coronary syndrome (ACS) and/or repeat revascularization

Time frame:12 weeks

Expanded / custom MACE composite

composite event, event

componentsUnstable angina hospitalization, Coronary revascularization

Secondary/protocol endpoint

Late lumen loss/neointima thickness measured with OCT

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in minimal lumen area by OCT

Time frame:12 weeks

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint/low confidence

Recovery from endothelial damage, measured by high resolution ultrasound, after PCI

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Plasma markers of endothelial activation i.e., E-Selectin, VCAM-1, ICAM-1, nitrotyrosine levels

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Plasma markers of inflammation i.e., CRP, IL-1β, IL-6 and IL-8.

Time frame:12 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Circulating endothelial progenitor cells

Time frame:12 weeks

descriptive

Other (unclassified)

6 endpoints
Secondary/protocol endpoint/low confidence

Fractional Flow Reserve (FFR)

Time frame:12 weeks

descriptive

Secondary/protocol endpoint/low confidence

Coronary Flow velocity Reserve (CRF)

Time frame:12 weeks

ratio, improvement

Secondary/protocol endpoint/low confidence

Index of Microcirculatory Resistance (IMR)

Time frame:12 weeks

descriptive

Secondary/protocol endpoint/low confidence

Left ventricular systolic and diastolic function assessed by echocardiography

Time frame:12 weeks

descriptive

Secondary/protocol endpoint/low confidence

Plasma markers of matrix remodeling enzymes i.e., MMP-2 and MMP9

Time frame:12 weeks

concentration, descriptive

Secondary/protocol endpoint/low confidence

Gene expression (Affymetrix) e.g., transcription factors of sirtuins (SIRT) and nitric oxide synthase (NOS)

Time frame:12 weeks

descriptive

Publications (8)

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.