Effects on re-endothelialisation in type 2 diabetic subjects on Bydureon treatment add on to Insulin versus Insulin alone, both in combination with Metformin.

• Conditions: Re-endothelialisation in type 2 diabetic subjects after Percutaneous coronary intervention (PCI) and stent placement.; MedDRA version: 18.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2015-000846-42-SE
• Lead Sponsor: Stockholm South General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-25
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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