Endothelial Effects of Basal Insulin: Detemir Versus Glargine
Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
Summary
Endothelial progenitor cell (EPC) level represents a surrogate marker of cardiovascular risk
and an indicator of the ongoing vascular damage. Moreover, EPCs are involved in the
pathogenesis of virtually all diabetic complications. Therefore, ways to modulate EPCs are
currently considered of utmost importance, especially in high-risk subjects. While many drugs
with pleiotropic vasculoprotective effects have shown ability to positively modulate EPCs,
there is no data on the effects of specific insulin formulations.
This is a human randomised cross-over comparison trial. The purpose is to compare the effects
of two basal insulin analogues (detemir and glargine) added to oral antidiabetic therapy in
poorly-controlled type 2 patients with cardiovascular disease on endothelial function and EPC
levels.
The aim is to test whether optimized glycemic control with add-on basal insulin analogues
improves endothelial damage and regeneration in type 2 diabetes with macroangiopathy and to
compare the effects of glargine vs detemir on markers of endothelial damage and regeneration.
EPC level is the most innovative outcome measure of this study and represents the primary
endpoint. Endothelial dysfunction/damage, evaluated using soluble markers, will be the
secondary outcome. Given the supposed inverse correlation between EPC and endothelial damage,
it is expected that EPC increase reflects amelioration in endothelial biology, a result that
may have significant clinical implications in this cohort of high-risk patients.