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

Stockholm South General Hospital0 个研究点开始时间: 2015年5月25日最近更新: 2015年12月7日

适应症

试验速览

暂无简介。

•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

•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

发起方

Stockholm South General Hospital