Clinical trial NCT00703482: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Patients With Type 2 Diabetes
Keywords: Ventricular diastolic Function
Diabetes
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-06-23
Enrollment: 278
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Evolution of the E'/E septal ratio
timeFrame: End of study (V6)
Secondary outcomes:
measure: Severity of the LVDD
timeFrame: End of study (V6)
measure: Evolution of the Left atrium and right atrium volumes
timeFrame: End of study (V6)
measure: Evolution of the Left and right sizes
timeFrame: End of study (V6)
measure: Evolution of the LVEDD and LVESD
timeFrame: End of study (V6)
measure: Evolution of the LVEDV and LVESV
timeFrame: End of study (V6)
measure: Evolution of the LV mass
timeFrame: End of study (V6)
measure: Evolution of the LV ejection fraction
timeFrame: End of study (V6)
measure: Evolution of the IVRT
timeFrame: End of study (V6)
measure: Evolution of the tissue Doppler E'/A' ratio
timeFrame: End of study (V6)
measure: Evolution of the PV doppler parameters
timeFrame: End of study (V6)
Other outcomes:
Locations:
city: Fremantle
country: Australia
facility: Site 002
city: Nedlands
country: Australia
facility: Site 003
city: Perth
country: Australia
facility: Site 001
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: