Clinical trial: Diabetes and Combined Lipid Therapy Regimen (DIACOR) Study (NCT00309712)

Eligibility criteria:
Inclusion Criteria:

          1. Controlled Type n Diabetes Mellitus (HbAlc <9%)

          2. Baseline levels ofLDL-C >100 mg/dL

          3. HDL-C <40 mg/dL

          4. Triglycerides :::200mg/dL and :::500mg/dL

          5. ALT and AST levels :::30%above the ULN with no active liver disease and CK :::50%above
             the ULN

          6. Alcohol consumption <2 drinks per day and with a maximum intake of <10 drinks per week

          7. Patients who are currently treated with pioglitazone (15 to 45 fig/day), rosiglitazone
             (2 to 8 fig/day), or metformin (500 mg to 2500 fig/day) as monotherapy or in
             combination with insulin or sulfonylureas must have been on a stable dose of these
             anti-diabetic agents for the previous 3 months

          8. Patients on warfarin or warfarin-like anticoagulants must agree to have their INRJPT
             levels drawn per standard of care by the local lab for adjustment of anticoagulant
             dosage

        j. The patient understands the requirements of the study, and voluntarily agrees to
        participate in the study and provides informed consent

        Exclusion Criteria:

          1. Uncontrolled Type n Diabetes Mellitus (HbAlc >9%);

          2. Known history of CAD

          3. Known history of myopathy or rhabdomyolysis

          4. Known history of intolerance to statins or fibric acid derivatives

          5. The use of lipid lowering agents or treatments therapy including bile acid
             sequestrants, HMG-Co-A reductase inhibitors, fish oil, nicotinic acid (doses >200
             mg/day) or niacin taken within 6 weeks prior to the eligibility for randomization
             visit or 8 weeks prior to the eligibility visit, if the patient is on fibrates

          6. Serum creatinine> 1.5 mg/elL. If serum creatinine is between 1.2 and 1.49 mg/elL, the
             calculated creatinine clearance using the Crockcroft/Gault [Crockcroft, 1976 #124]
             formula must be >50 ml/min to be included in this study

        Formula for Males:

        CrCI= (140-age [years])x (body weight [kg]) (72) x (serum Cr [mg/elL])

        Formula for Females:

        CrCI=(140-age [years]) x (body weight [kg]) x 0.85 (72) x (serum Cr [mg/dL]) g. Active
        liver disease including viral hepatitis (hepatitis B or C) as determined by positive
        antibodies to core and surface antigen for hepatitis B, and positive antibodies for
        hepatitis C h. Uncontrolled hypertension (treated or untreated) with systolic blood
        pressure >160 mmHg or diastolic blood pressure >100 mmHg i. Proteinuria as defined by >0.5
        mg albumin per mg creatinine (if dipstick> 1+) or history of nephrotic syndrome j.
        Secondary hypercholesteremia due to hypothyroidism (TSH >6~U/mL) or nephrotic syndrome;
        Patients with a history of hypothyroidism, who are on a stable dose of thyroxine with
        normalized plasma thyroxine and TSH may be included k. Diagnosis of homozygous familial
        hypercholesteremia, or Types I or V hyperlipidemia 1. The concomitant use of cyclosporine;
        systemic itraconazole or ketoconazole, erythromycin or clarithromycin, nefazadone, or HIV
        protease inhibitors are excluded. The concomitant use of systemic (pO or IV)
        glucocorticoids, and verapamil (other calcium channel blockers are acceptable), or the
        consumption oflarge amounts of grapefruitjuice (> 1 quart) are excluded. m. Known
        hypersensitivity to any component of HMG-CoA reductase inhibitors or fibrates including
        history of elevated liver or muscle function tests, jaundice, or hepatotoxicity or myopathy
        associated with these treatments n. History of partial ileal bypass o. Treatment with any
        other investigational drug within the previous 30 days Currently using illicit drugs;
        history of drug or alcohol abuse within the past 5 years Type 1 diabetes mellitus,
        hyperlipidemicpancreatitis or known presence of cholelithiasis (gallstones); Any therapy or
        condition that would pose a risk to the patient or make it difficult for the patient to
        comply with requirements of the study s. Participation in any other studies involving
        investigational or marketed products within 30 prior to entryin the study. .

        1. Pregnantand/orlactatingwomen,andwomenof childbearingpotentialnot usingacceptablemeansof
        contraception.Womenof childbearingpotentialmustbe usingadequatemeasuresof contraception(as
        determinedby the investigator)to avoidpregnancyandshouldbe highlyunlikelyto
        conceiveduringthe study period. Womenof childbearingpotentialmusthavea
        negativepregnancytest at the timeof initialscreening.
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.


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? Contradiction