Type 2 Diabetes Clinical Trial
Official title:
Randomized, Open Label, Two Parallel Arms, Intervention Trial Comparing the Effect of DPP-IV Inhibitor Vildagliptin vs. Glibenclamide on Circulating Endothelial Progenitor Cell Number in Patients With Type 2 Diabetes in Metformin Failure
The purpose of this study is to evaluate the effect of DPP-IV inhibitor Vildagliptin vs. Glibenclamide on circulating endothelial progenitor cells (EPCs) number in type 2 diabetes patients in metformin failure. Subjects will be followed for 12 months after randomization.
Diabetic patients show a higher cardiovascular risk compared with non-diabetic patients. It
is therefore crucial that blood glucose lowering drugs reveal a favorable cardiovascular
risk profile independently of metabolic control.
EPCs are a subset of circulating mononuclear cells derived from the bone marrow. EPCs play a
fundamental role in the formation of new blood vessels (neo-endothelization) and repairing
of existing blood vessels (re-endothelization) in order to maintain endothelial homeostasis
and integrity. Endothelial damage and tissue ischemia, through the release of growth factors
and cytokines, represent a strong stimulus for the mobilization of EPCs from the bone
marrow. Reduced EPC number has been related to the presence of traditional risk factors for
cardiovascular disease and to the development of atherosclerosis and has been shown to
predict cardiovascular (CV)risk. Type 2 diabetes is known to be associated with an increased
CV risk and a reduced EPC number. Recent data suggest that DDP-IV inhibitors might be
involved in the mechanisms promoting bone-marrow EPC mobilization. This putative ancillary
effect of DPP-IV might have a favorable impact on type 2 diabetes, a condition characterized
by an increased CV risk.
This is a randomized, open-label, active-treatment-controlled, two parallel arm (2:1),
intervention trial comparing DPP-IV inhibitor Vildagliptin (100 mg daily) with Glibenclamide
(maximum daily dose of 10 mg). Treatment allocation and titration regimens are not blinded.
Primary end-point:Absolute and relative change in the EPC number at visit: V0
(randomization), V2 (month 4), V3 (month 8) and V4 (month 12).
Secondary end-point: Absolute and relative change in HbA1C compared to baseline.
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