Diabetes and Combined Lipid Therapy Regimen (DIACOR) Study

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary study hypothesis of this study is to determine whether there is a greater percentage of patients achieving a triglyceride level of <200 mg/dL with the combination of simvastatin 20 mg and fenofibrate 160mg than with either simvastatin 20 mg monotherapy or fenofibrate 160mg monotherapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intermountain Health Care, Inc.
• Collaborators: Abbott; Merck Sharp & Dohme Corp.
• Treatments: Fenofibrate; Simvastatin

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.