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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to use Exenatide long-acting release (LAR) [Bydureon] to minimize vascular remodeling and neointima formation after Percutaneous Coronary Intervention (PCI) and to accelerate stent endothelialisation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet
• Treatments: Biguanides; Exenatide; Insulin; Insulin Aspart; Insulin, Globin Zinc; Insulin, Isophane; Metformin

Criteria

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.