Type 2 Diabetes Mellitus Clinical Trial
Official title:
Effect of Dapagliflozin on Cardio-Metabolic Risk Factors in Patients With Type-2 Diabetes
Dapagliflozin is a member of the sodium-glucose cotransporter-2 (SGLT2) inhibitor class
antidiabetes agents which produces significant and sustained reductions in glycemic
parameters in patients with type 2 diabetes (T2DM). However, its non-glycemic effects are
still largely unknown.
The investigators will evaluate for the first time the effect of dapagliflozin on multiple
cardio-metabolic risk markers in one study. So far, no data on the effects of dapagliflozin
as well as other SGLT-2 inhibitors on subclinical atherosclerosis, endothelial function,
inflammatory markers, cytokines and atherogenic lipoproteins is available.
In addition, the investigators will examine microRNAs (miRNAs) implicated in the development
and progression of atherosclerotic disease. Again, no data is currently available on
dapaglifozin's as well as other SGLT-2 inhibitors' effects on miRNAs.
The results of this study will show for the first time the potential multiple, non-glycemic
effects of dapagliflozin, reducing multiple cardio-metabolic risk markers, which will
ultimately lead to decreased CV risk.
In addition, specific mechanisms of the dapagliflozin cardiovascular action will be
investigated.
Finally, the results of this study may pave the way for personalized therapy (using the
results on miRNAs).
The investigators will perform an open label, two-arms, prospective intervention study using
dapagliflozin+metformin vs. metformin alone for a period of 6 months in patients with T2DM.
The research hypothesis is to assess whether dapagliflozin can improve cardio-metabolic
outcome, reducing subclinical atherosclerosis, endothelial dysfunction and different
cardio-metabolic markers (including inflammatory markers, cytokines, oxidative stress and
atherogenic lipoproteins) in patients with T2DM.
The primary objective is to assess the effects of dapagliflozin on subclinical
atherosclerosis, as assessed by carotid intima-media thickness (cIMT).
Primary endpoint: Reduction in cIMT.
The secondary objective is to assess the effects of dapagliflozin on glycemic parameters
(fasting plasma glucose (FPG), HbA1c), endothelial dysfunction, oxidative stress, atherogenic
lipoproteins, inflammatory markers, cytokines and microRNAs (miR-130a, miR-27b, miR-29b and
miR-210).
Secondary endpoint: Reduction in glycemic parameters, atherogenic lipoproteins, inflammatory
markers, oxidative stress and improvements in endothelial function, cytokines and microRNAs
(miR-130a, miR-27b, miR-29b and miR-210).
The full data for clinical and biochemical analyses will be collected in the same fashion at
baseline and after 6 months of therapy.
Control visits by the telephone calls will be made every 2 months. However, in case of need,
unplanned visits will be scheduled. Unscheduled visits will be performed in case of
discontinuation, withdrawal, rescue treatment (including adverse event, episodes of
hypoglycemia) or at any time during the study in case of patient's need.
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