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

Sponsor

Solvay Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00703482

Collaborator

(none)

278

Enrollment

Locations

Arms

16.1

Duration (Months)

92.7

Patients Per Site

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Patients With Type 2 Diabetes	Drug: Fenofibrate/CoQ10 Drug: Fenofibrate/CoQ10 Drug: Fenofibrate/CoQ10 Drug: Fenofibrate/CoQ10 Drug: Fenofibrate/CoQ10 Drug: Fenofibrate/CoQ10 Drug: Fenofibrate/CoQ10	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

278 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2003

Actual Primary Completion Date :

Sep 1, 2004

Actual Study Completion Date :

Sep 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1	Drug: Fenofibrate/CoQ10 Fenofibrate pbo/CoQ10 placebo Drug: Fenofibrate/CoQ10 Fenofibrate 160mg/CoQ10 placebo
Active Comparator: 2	Drug: Fenofibrate/CoQ10 Fenofibrate pbo/CoQ10 200 mg
Active Comparator: 3	Drug: Fenofibrate/CoQ10 Fenofibrate 160mg/CoQ10 placebo
Experimental: 4	Drug: Fenofibrate/CoQ10 Fenofibrate 80/CoQ10 100 mg
Experimental: 5	Drug: Fenofibrate/CoQ10 Fenofibrate 160mg/CoQ10 100 mg
Experimental: 6	Drug: Fenofibrate/CoQ10 Fenofibrate 80 /CoQ10 200 mg
Experimental: 7	Drug: Fenofibrate/CoQ10 Fenofibrate 160mg/CoQ10 200 mg

Outcome Measures

Primary Outcome Measures

Evolution of the E'/E septal ratio [End of study (V6)]

Secondary Outcome Measures

Severity of the LVDD [End of study (V6)]
Evolution of the Left atrium and right atrium volumes [End of study (V6)]
Evolution of the Left and right sizes [End of study (V6)]
Evolution of the LVEDD and LVESD [End of study (V6)]
Evolution of the LVEDV and LVESV [End of study (V6)]
Evolution of the LV mass [End of study (V6)]
Evolution of the LV ejection fraction [End of study (V6)]
Evolution of the IVRT [End of study (V6)]
Evolution of the tissue Doppler E'/A' ratio [End of study (V6)]
Evolution of the PV doppler parameters [End of study (V6)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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