Effects of ezetimibe in association with statins on postprandial lipemia in type 2 diabetic patients

INTERVENTION: Pharmaceutical Form: Tablet INN or Proposed INN: Simvastatin and ezetimibe Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical Form: Tablet INN or Proposed INN: Simvastatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ CONDITION: Type 2 diabetes mellitus ; MedDRA version: 9.1 Level: SOC Classification code 10027433 ; MedDRA version: 9.1 Level: HLGT Classification code 10013317 ; MedDRA version: 9.1 Level: PT Classification code 10062060 ; MedDRA version: 9.1 Level: LLT Classification code 10020661 PRIMARY OUTCOME: Main Objective: The aims of this protocol are to evaluate the effects of ezetimibe ‐ in association with a statin vs. a statin alone ‐ on postprandial lipemia, in particular on the number and composition of either intestinally derived and hepatic derived lipoprotein particles, in type 2 diabetic patients. Primary end point(s): Incremental AUC after a fat‐rich meal of cholesterol concentration in chylomicron and VLDL fractions. Secondary Objective: to evaluate the effects of ezetimibe ‐ in association with a statin vs. a statin alone ‐ on: ‐ Fasting LDL cholesterol concentration. ‐ Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions. ‐ Postprandial LDL size. ‐ Concentration and Composition of different lipoprotein subclasses in the fasting condition. INCLUSION CRITERIA: ‐ Type 2 diabetes since at least two years ‐ Stable metabolic control (HbA1c<8.0%) for at least six months on diet or diet+oral hypoglycemic drugs (insulin secretagogues or metformin), not to be changed during the study period. ‐ BMI<30 kg/m2 and body weight stable during the last six months. ‐ Both sexes; only post‐menopausal women. ‐ LDL‐cholesterol >130 mg/dl, plasma triglycerides <400 mg/dl. ‐ No use of hypolipidemic drugs in the last three months. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range