Effect of simvastatin on myocardial triglyceride accumulation, cardiac function and vessel wall thickness in patients with type 2 diabetes mellitus

INTERVENTION: Product Name: simvastatine Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: simvastatine CAS Number: 79902‐63‐9 Concentration unit: g gram(s) Concentration type: equal Concentration number: 0.04‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: diabetes mellitus type 2 ; MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus PRIMARY OUTCOME: Main Objective: To study the effect of simvastatin on myocardial triglyceride accumulation and cardiac function in diabetes mellitus type 2 using MRI and MR spectroscopy Primary end point(s): Difference in the following end‐points after placebo or simvastatine in:; myocardial triglyceride content; heart dimensions; systoloic and diastolic heart function Secondary Objective: To study the effect of simvastatin on:; ‐ total vessel wall area and thickness ; ‐ liver triglyceride content; INCLUSION CRITERIA: diabetes mellitus type 2 treated with metformin alone or in combination with SU‐derivate HbA1c< 8.5% well regulated blood pressure BMI >20 kg/m2 and <35 kg/m2 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