A phase III, four-armed, randomised, double blind, parallel study to compare the efficacy and safety in type 2 diabetic patients with combined hyperlipidemia of a 12-week administration of Fenofibrate 160mg/Pravastatin 40mg combination versus Simvastatin 20mg in patients without Cardiovascular disease (CVD) (group 1) and of Fenofibrate 160mg/Pravastatin 40mg combination+Ezetimibe 10mg versus Simvastatin 20mg+Ezetimibe 10mg in patients with CVD (group 2), followed by a 12-week safety phase of Fenofibrate 160mg/Pravastatin 40mg combination in group 1 and of Fenofibrate 160mg/Pravastatin 40 mg combination+Ezetimibe 10mg in group 2. - PREFED PRavastatin, Ezetimibe and FEnofibrate in Diabetic patients

Phase 1

Conditions: Type 2 diabetic patients, as defined by the WHO without CVD and with CVD (Cardiovascular disease), with combined hyperlipidemia.
MedDRA version: 9.1Level: LLTClassification code 10027763Term: Mixed hyperlipidemia

Registration Number: EUCTR2006-006557-28-FR

Lead Sponsor: aboratoires SMB S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 480

Inclusion Criteria

Selection criteria :
· Male or female, aged 18 years and older
· Type 2 diabetic patients as defined by the WHO without CVD and with CVD
· Patients presenting a known combined hyperlipidemia (to be documented by physician)
· Patients following a standardized diet for at least three months before the selection visit and to be maintained stable throughout the study
· Able to comply with all study procedures
· Provide written, informed consent to participate in the study, indicated by a personal signature and date on the patient consent form
· If the patient is female and of childbearing potential, she must be using an efficient mean of birth control, as determined by the investigator and provide a negative serum pregnancy test

Inclusion criteria :
· Patients with non-HDL-C > or = 130 mg/dl (3.36 mmol/l) [or LDL C > or =100 mg/dl (2.6 mmol/l)] and without CVD, or non-HDL-C > or =100 mg/dl (2.59 mmol/l) [or LDL-C> or = 70 mg/dl (1.8 mmol/l)] and with CVD, at the laboratory sample taken one week before the randomisation visit
· TG > or =150 mg/dl (1.7 mmol/l) and < or =600 mg/dl (6.8 mmol/l) at the laboratory sample taken one week before the randomisation visit
· Patients always respecting the selection criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· Secondary or iatrogenic dyslipidemia
· Hyperlipidemia type I-IIa-IV-V
· Abnormal liver function [hepatocellular insufficiency, chronic or active liver disease, biliary tract disease, sustained elevation of serum liver enzymes (simultaneous ASAT/SGOT and ALAT/SGPT > 2x ULN at laboratory sample B1 or B2)]
· CPK > 3x ULN at laboratory sample B1 or B2
· Abnormal renal function (clearance of creatinine < 60 ml/mn and creatinemia > 15 mg/l at laboratory sample B1 or B2) or any renal disease likely to lead to renal dysfunctions
· Patients who had an acute cardiovascular episode within the 3 months previous to the start of the trial, or with a history of coronary angioplasty with mounting of a Stent within the past 6 months
· Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg) under blood pressure treatment·Evidence of any other unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, neurological or psychiatric abnormalities or medical disease
· Presence of any other condition or illness, which, in the opinion of the investigator would interfere with optimal participation in the study and likely to jeopardize the planned termination of the study
· Patients with any sensitivity or allergy to any of the products used within this clinical trial: known hypersensitivity to HMG-COA reductase inhibitors, fibric acid derivatives or ezetimibe
· Uncontrolled primary hypothyroidism
· Uncontrolled diabetes with HbA1c > 8.5% at laboratory sample B1 or B2
· Diabetes requiring insulin
· Use of any of the prohibited medication as detailed in the non-permitted medication section
· Non adherence to a stable standardized diet during the study
· Patients with high alcohol consumption (above 21 beverages per week or with a recent history of alcoholism : one alcoholic beverage is defined as 30 mL distilled spirits, 120 mL wine, or 330 mL beer)
· Patients with a personal or family history of hereditary muscle disease
· Patients with poor cognitive function
· Participation in any other clinical trial within 3 months before the selection visit
· Childbearing potential woman not using an appropriate contraceptive method, pregnant or breastfeeding woman
· Patient not covered by Health Insurance System and / or not in compliance with the recommendations of National Law in force
· Participation in any other trials with the fenofibrate-pravastatin 160-40 mg SMB product
· Compliance <80% during the run-in phase

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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