Re-endothelialisation in type 2 diabetic subjects after Percutaneous coronary intervention (PCI) and stent placement. MedDRA version: 18.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Bydureon
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: EXENATIDE
CAS Number: 141758-74-9
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Stockholm South General Hospital
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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 200 mm Hg at screening 7. Primary renal impairment, creatinine clearance 5.5 mmol/l). 9. Significant anemia (Hb 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test whether Bydureon, add on to Insulin (NPH) + Metformin, is superior vs. Insulin + Metformin alone, in covered stent struts ;Secondary Objective: To test whether Bydureon, add on to Insulin (NPH) + Metformin, is superior vs. Insulin + Metformin alone: in cardiac and endothelial functions ;Primary end point(s): The primary endpoint is defined as the degree of non-covered stent struts by Bydureon add on to Insulin at 3 months over that of Insulin as analyzed by optical coherence tomography (OCT).;Timepoint(s) of evaluation of this end point: 3 months after Bydureon add on treatment to Insulin versus Insulin alone | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes between groups at 3 months of Bydureon add on to Insulin versus Insulin alone, both in combination with Metformin treatment, regarding: • Coronary physiologic indices such as FFR, CFR and IMR • Fractional flow reserve positive re-stenosis • Target lesion failure • Acute coronary symdrome (ACS) and/or repeat revascularization • Late lumen loss/neointima thickness measured with OCT • Change in minimal lumen area by OCT • Left ventricular systolic and diastolic function assessed by echocardiography • Recovery from endothelial damage after PCI • Plasma markers of endothelial activation i.e., E-Selectin, VCAM-1, ICAM-1, nitrotyrosine levels • Plasma markers of inflammation i.e., CRP, IL-1ß, IL-6 and IL-8. • Plasma markers of matrix remodeling enzymes i.e., MMP-2, MMP9 and PAI-1 • Circulating endothelial progenitor cells • Gene expression (Affymetrix) e.g., transcription factors of sirtuins (SIRT) and nitric oxide synthase (NOS) • Lipids • HbA1c • Body weight • Blood Pressure ;Timepoint(s) of evaluation of this end point: 3 months after Bydureon add on treatment to Insulin versus Insulin alone | — |
Countries
Sweden
Contacts
Public ContactStockholm South General Hospital
Stockholm South General Hospital
Outcome results
None listed