Clinical trial: Ezetimibe and Simvastatin in Dyslipidemia of Diabetes (NCT00157482)

Eligibility criteria:
Inclusion Criteria:

          -  Type 2 diabetes mellitus with stable antidiabetic treatment since at least three
             months

          -  Total cholesterol concentrations >135mg/dl and/or concomitant lipid lowering therapy
             with HMGCoA inhibitors

          -  Serum creatinine ≤1.5mg/dl

          -  Urinary albumin excretion rate < 200μg/min

          -  Written informed consent

        Exclusion Criteria:

          -  History of myocardial infarction, stroke or hospital admission for angina within the
             previous 6 months

          -  History of percutaneous transluminal coronary angioplasty or coronary artery bypass
             grafting

          -  Clinically manifest heart failure (grade III or above according to New York Heart
             Association criteria)

          -  Poor glycemic control (HbA1C >11%)

          -  Primary hyperlipidemia

          -  Uncontrolled thyroid diseases

          -  Infectious disease within 4 weeks of starting

          -  Acute liver disease or hepatic dysfunction

          -  Inflammatory muscle disease or evidence of muscle problems

          -  Concurrent treatment with systemic steroids, androgens, cyclosporin and other
             immunosuppressive drugs, fibrates, high-dose niacin or cholestyramine

          -  Pregnancy or lactating

          -  Women of childbearing potential without following a scientifically accepted form of
             contraception

          -  Life-threatening conditions or terminal concomitant diseases other than diabetes

          -  Specific contraindications or history of hypersensitivity to the study drugs or other
             statins

          -  Legal incapacity and/or other circumstances rendering the patient unable to understand
             the nature, scope and possible consequence of the trial

          -  Evidence of an uncooperative attitude

          -  Any evidence that patient will not be able to complete the trial follow-up
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Entailment