Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effectiveness and Tolerability of Early Initiation of Combined Lipid -Lowering Therapy Included Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus, Hypertriglyceridemia and Acute Coronary Syndrome
To test the hypothesis that early (within 5-21 days after index event) administration of combined lipid-lowering therapy in extremely high risk population of patients with type 2 diabetes mellitus (T2DM) and hypertriglyceridemia (HTG) who experienced acute coronary syndrome (ACS) will be effective and well tolerated in achievement of contemporary strict requirements for triglyceride (TG) levels as an independent risk factor in the case of HTG with diabetes.
The primary objective of this parallel group study is to demonstrate that the combined
therapy of simvastatin and fenofibrate is superior compared to monotherapy with simvastatin
based on the comparisons of change of TG levels after 12 weeks of treatment compared to
baseline.
Secondary objectives are to compare both treatment alternatives the combination therapy of
simvastatin and fenofibrate to simvastatin monotherapy with respect to achievement the
European Society of Cardiology 2011 (ESC 2011) non-HDL-C target (less than 2,6 mmol/l),
change of apolipoprotein B/apolipoprotein A1 (apoB/apoA1) ratio, High-Density
Lipoprotein-Cholesterol (HDL-C), Low-Density Lipoprotein-Cholesterol (LDL-C) and Uric Acid
(UA) after 12 weeks and 52 weeks (1 year) of treatment compared to baseline.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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