A Randomised, Double-Blind, Placebo-Controlled Study Assessing the Effect of Fenofibrate, Coenzyme Q10 and Their co-Administration on Ventricular Diastolic Function in Patients With Type 2 Diabetes

A Randomised, Double-Blind, Placebo-Controlled Study Assessing the Effect of Fenofibrate, Coenzyme Q10 and Their co-Administration on Ventricular Diastolic Function in Patients With Type 2 Diabetes

The purpose of this study was to study the effect of different combinations of fenofibrate and coenzyme Q10 on ventricular diastolic function in patients with Type II diabetes

Inclusion Criteria:

• Men or women aged from 40 to 79 years
• Patients with pre-existing T2DM
• HbA1C <9%
• Written informed consent

Exclusion Criteria:

• unable to comply with the protocol, Likely to leave the trial before completion
• having participated in an another trial 3à days before V1
• Pregnant or childbearing potential not using birth control method
• Type 1 diabetic patients, T2Dm insulin therapy

Patients with one of the following pathology:

• with muscular disorders known or increase CK , or hepatic deficiency or transaminase increase
• with symptomatic gall-bladder disease or/and renal insufficiency
• with abnormal thyroid function
• with proliferative retinopathy
• with recent cardiovascular event, uncontrolled hypertension
• with known chronic alcohol intake
• with other severe pathology
• with TC>= 7.0 mmol/L and/or TG>= 4mmol/L at V1
• Patients treated with Warfarin
• Patients with specific ECG dysfunction