Effect of Empagliflozin and Semaglutide on Cardio-Renal Target Organ Damage in patients with type 2 diabetes – A randomized Trial

Aarhus University Hospital0 sites120 target enrollmentMarch 14, 2019

Overview

No summary available.

Registry

who.int

Start Date

March 14, 2019

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Aarhus University Hospital

•Diagnose of type 2 diabetes.
•HbA1c level of 7% (53 mmol/mol) or more.
•Age of 50 years or more with established cardiovascular disease (prior myocardial infarction, prior stroke or prior transient ischemic attack, prior coronary, carotid or peripheral arterial revascularization, more than 50 % stenosis on angiography or imaging of coronary, carotid or lower extremities arteries, history of symptomatic coronary heart disease documented by e.g. positive exercise stress test or any cardiac imaging or unstable angina with electrocardiography (ECG) changes), or chronic heart failure (New York Heart Association class II or III).
•Age of 60 years or more with at least one cardiovascular risk factor (persistent microalbuminuria (30\-299 mg/g) or proteinuria, hypertension and left ventricular hypertrophy by electrogram or imaging, left ventricular systolic or diastolic dysfunction by imaging or ankle/brachial index less than 0\.9\).
•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 60
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 60

•Estimated glomerular filtration rate \< 60 ml/min.
•Treatment with a SGLT2\-inhibitor, GLP\-1\-receptor agonist or dipeptidyl\-peptidase 4 inhibitor within 30 days before screening or insulin other than basal or premixed within 30 days before screening.
•A history of an acute coronary or cerebrovascular event within 90 days before randomization.
•Planned revascularization of a coronary, carotid, or peripheral artery.
•Inability to give informed consent.
•Active cancer diagnosis other than basal cell carcinoma.
•Indication of liver disease (serum ALAT, ASAT or alkaline phosphatase above 3 x upper limit).
•Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.
•Treatment with systemic steroids at time of randomization.
•Change in dosage of thyroid hormones within 6 weeks prior to screening.