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

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Solvay Pharmaceuticals
• Treatments: Coenzyme Q10; Fenofibrate; Ubiquinone

Criteria

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