An observational study in Type 2 Diabetes, sponsored by University of Padova. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-03-11.
Sponsored by University of Padova · Observational
Patients with type 2 diabetes (T2D) suffer from an excess risk of adverse cardiovascular events. Recently, two classes of glucose lowering agents, namely SGLT-2 inhibitors (SGLT2i) and GLP-1 receptor agonists (GLP-1RA), have proved superior to placebo in protecting T2D patients from cardiovascular events in dedicated trials. Patient populations in such trials were mainly composed of T2D individuals with established cardiovascular disease (CVD) or at very high risk for CVD. In addition, no clinical trial has so far compared cardiovascular outcomes of T2D associated with SGLT2i versus GLP-1RA. In addition, whether different results would incur in patients at lower CVD risk is unclear. On this basis, we designed this retrospective real-world study to compare cardiovascular outcomes of patients newly treated with SGLT2i versus GLP-1RA in routine clinical practice
University of Padova is the lead sponsor of 210 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Type 2 diabetes
Exclusion Criteria:
Patients who received new prescription of a SGLT-2 inhibitor
Drug: SGLT2 inhibitor
Patients who received new prescription of a GLP-1 receptor agonist
Drug: GLP-1 receptor agonist
New prescription of a SGLT-2 inhibitor (dapagliflozin, empagliflozin or canagliflozin) at any dosage during routine clinical practice
New prescription of a GLP-1 receptor agonisty (exenatide, liraglutide, lixisenatide, dulaglutide) at any dosage during routine clinical practice
3 point major adverse cardiovascular events (4P-MACE)
First occurrence of myocardial infarction, stroke, or death
Time frame: 3-26 months after index date
Hospitalization for cardiovascular causes
First hospitalization for any cardiovascular cause
Time frame: 3-26 months after index date
Death
All-cause death
Time frame: 3-26 months after index date
Myocardial infarction
Myocardial infarction
Time frame: 3-26 months after index date
Heart failure
Hospitalization for heart failure
Time frame: 3-26 months after index date
Stroke
Stroke or transient ischemic attack
Time frame: 3-26 months after index date
Revascularization
Any arterial site revascularization (surgical or endovascular)
Time frame: 3-26 months after index date
Occurrence of adverse events
Occurrence of: amputation, Fournier's gangrene, bone fracture, diabetic ketoacidosis, infections, pancreatitis, pancreatic cancer, acute kidney injury
Time frame: 3-26 months after index date
Plan to share: No — Data cannot be shared
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Padova