Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus
Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus
The study will investigate the effects of atorvastatin on the concentrations of small, dense
 LDL and HDL subfractions in patients with diabetes and the underlying mechanisms of these
 effects.
This study was terminated on October 6, 2004. The study terminated prematurely because of a
 higher screening failure rate than expected. There were no safety or efficacy reasons
 involved in the decision to terminate.
Inclusion Criteria:

 -  Male and female subjects with a diagnosis of type 2 diabetes mellitus who either have
 never had a major adverse cardiac event (MACE) diagnosed before or who had a MACE
 diagnosed at least 6 months ago, but who, according to the judgement of the treating
 general practitioner, do not receive any hyperlipidemic therapy. Major adverse cardiac
 events (MACE) include myocardial infarction, coronary angioplasty, coronary artery
 bypass graft or other revascularization procedures.

 At Screening:

 Visit 1 (week -4):

 1. Male patients aged >35 and ≤75 years and postmenopausal female patients ≤75 years with
 a diagnosis of type 2 diabetes mellitus

 2. Patients have been euthyroid for at least six months

 3. Written informed consent obtained

 At Visit 2 (week 0):

 4. LDL cholesterol ≥130 mg/dl (3.3 mmol/l ) and <190 mg/dl (4.9 mmol/l)

 5. Triglycerides <150 mg/dl (1.69 mmol/l ) and <600 mg/dl (11.3 mmol/l)

 6. Sum of LDL-5 and LDL-6 cholesterol ≥25 mg/dl (0.65 mmol/l)

 7. Follicle stimulating Hormone (FSH) >30 U/l in female patients aged <60 years or FSH
 >20 U/l in female patients aged ≥60 years

 Exclusion Criteria:

 -  HbA1c > 8.0

 -  Creatine kinase (CK) >5 times the upper limit of normal

 -  Patients having taken lipid lowering medication within 8 weeks of the screening visit