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

S

Solvay

Status and phase

Completed

Phase 2

Conditions

Patients With Type 2 Diabetes

Treatments

Drug: Fenofibrate/CoQ10

Study type

Interventional

Funder types

Industry

Identifiers

NCT00703482

CFEN0205

Details and patient eligibility

About

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

Enrollment

278 patients

Sex

All

Ages

40 to 79 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

278 participants in 7 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: Fenofibrate/CoQ10

2

Active Comparator group

Treatment:

Drug: Fenofibrate/CoQ10

3

Active Comparator group

Treatment:

Drug: Fenofibrate/CoQ10

4

Experimental group

Treatment:

Drug: Fenofibrate/CoQ10

5

Experimental group

Treatment:

Drug: Fenofibrate/CoQ10

6

Experimental group

Treatment:

Drug: Fenofibrate/CoQ10

7

Experimental group

Treatment:

Drug: Fenofibrate/CoQ10

Trial contacts and locations

3

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