Platelet function in diabetic patients without and with renal impairment, and the effects of lipid-lowering treatment

INTERVENTION: Trade Name: Zocord R Product Name: Zocord R Pharmaceutical Form: Tablet INN or Proposed INN: Simvastatin Concentration unit: mg milligram(s) Concentration number: 40‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Ezetrol Product Name: Ezetrol R Pharmaceutical Form: Tablet INN or Proposed INN: ezetimibe Concentration unit: mg milligram(s) Concentration number: 10‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Diabetes mellitus type 2, without or with renal impairment PRIMARY OUTCOME: Main Objective: To compare the effects of simvastatin + ezetimibe with those of simvastatin alone, on thrombogenic mechanisms, in patients with diabetes mellitus type 2. Primary end point(s): ADP stimulated platelet P‐selectin expression (flow cytometry in whole blood).; Other flow cytometric platelet variables related to the primary end point are (a) circulating platelet‐platelet aggregates, (b) circulating platelet‐leukocyte aggregates, (c) single platelet counts.; Secondary Objective: a) Compare the effects of simvastatin alone with those of placebo (baseline data) on thrombogenic mechanisms; b) Compare the effects of simvastatin + ezetimibe with those of simvastatin alone, and simvastatin alone with placebo on inflammatory variables.; c) Assess how the treatment effects relate to renal function. ; INCLUSION CRITERIA: Diabetes mellitus type 2 With or without established microalbuminuria (urinary albumin excretion of 30‐299 µg/mg creatinine in a spot sample) Two out of three specimens collected within a 3‐6 month period should be abnormal before the diagnosis can be settled. Glomerular filtration rate (GFR) between 15‐50 ml/min (measured the last 6 months) or GFR >75ml/min. GFR will be established by 24‐hour Iohexolclearence. Age 18‐80 years 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) yes F.1.3.1 Number of subjects for this age range