Effects of Empagliflozin + Linagliptin vs Metformin + Insulin Glargine on Renal and Vascular Changes in Type 2 Diabetes
Status:
Completed
Trial end date:
2019-05-01
Target enrollment:
Participant gender:
Summary
Diabetes mellitus is a wide-spread disease accompanied by strongly increased morbidity and
mortality due to micro- and macrovascular complications. However, in studies with patients
suffering from diabetes mellitus type 2 (DM 2), early changes and impairments in large and
small blood vessels as well as organ damage (e. g. to the kidneys) have been only
insufficiently investigated (1). The newest substance class in oral antidiabetics, i. e.
SGLT-2-inhibitors (such as empagliflozin) cause an increased renal excretion of glucose. In
addition, the concurrent increased sodium excretion brings about an improvement of vascular
function and thus a decrease in blood pressure. In the EMP-REG-OUTCOME study (2), the
cardiovascular mortality rate was significantly lower in the empagliflozin group (3.7% versus
5.9%; 38% relative RR) compared to placebo.For another new substance class, the
dipeptidylpeptidase-4-inhibitors, a number of pleiotropic effects have been described (3). In
one of our recently conducted trials, we could demonstrate a positive effect of linagliptin
on renal an inflammatory parameters compared to placebo (4). Thus, the combination of both
substance classes with regard to positive effects on micro- and macrocirculation, even though
not sufficiently proven as yet, suggests itself. The therapy with metformin and long-acting
insulin (BOT), as well as a twofold oral medication is possible according to the
recommendations of the "Deutsche Diabetes Gesellschaft (DDG)" and the positional paper of the
"American Diabetes Association (ADA)". Accordingly, the aim of the present paper is the
analysis of the effects of a combined therapy with empagliflozin plus linagliptin compared to
metformin plus insulin glargine on renal and vascular changes in type 2 diabetes mellitus.