POSTPRANDIAL LIPEMIA, INFLAMMATION, AND VASCULAR FUNCTION IN DIABETES MODULATED BY SGLT2 INHIBITION

INTERVENTION: Trade Name: Forgixa Pharmaceutical Form: Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Diabetes Mellitus type II ; Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: To explore the effects of dapagliflozin compared with placebo on postprandial leukocyte activation markers in men with type 2 diabetes mellitus. Primary end point(s): Effect of dapagliflozin on postprandial leukocyte activation markers (CD35, Cd11b and CD66b) Secondary Objective: To explore the effect of a dapagliflozin compared with placebo on postprandial lipemia, oxidative stress and endothelial function in men with type 2 diabetes mellitus Timepoint(s) of evaluation of this end point: At end of study (after 12 weeks of treatment). SECONDARY OUTCOME: Secondary end point(s): Effect of dapagliflozin on postprandial lipemia, oxidative stress and vascular function. Timepoint(s) of evaluation of this end point: At end of study (after 12 weeks of treatment). INCLUSION CRITERIA: ‐ Age of 18 years of older; ‐ Male ‐ Diabetes mellitus type 2 on intensive insulin treatment (three times short acting and once daily long acting) (unchanged for > 10 weeks prior to consent) ‐ Stable glucose regulation last 6 months (HbA1c > 6.5% ‐ < 9.0%) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range