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 - Full Text View

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00703482

Purpose

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	Intervention	Phase
Patients With Type 2 Diabetes	Drug: Fenofibrate/CoQ10	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Procetofen Coenzyme Q10

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Evolution of the E'/E septal ratio [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Severity of the LVDD [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
Evolution of the Left atrium and right atrium volumes [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
Evolution of the Left and right sizes [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
Evolution of the LVEDD and LVESD [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
Evolution of the LVEDV and LVESV [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
Evolution of the LV mass [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
Evolution of the LV ejection fraction [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
Evolution of the IVRT [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
Evolution of the tissue Doppler E'/A' ratio [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]
Evolution of the PV doppler parameters [ Time Frame: End of study (V6) ] [ Designated as safety issue: No ]

Enrollment:	278
Study Start Date:	May 2003
Study Completion Date:	September 2004
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Fenofibrate/CoQ10 Fenofibrate pbo/CoQ10 placebo Drug: Fenofibrate/CoQ10 Fenofibrate 160mg/CoQ10 placebo
2: Active Comparator	Drug: Fenofibrate/CoQ10 Fenofibrate pbo/CoQ10 200 mg
3: Active Comparator	Drug: Fenofibrate/CoQ10 Fenofibrate 160mg/CoQ10 placebo
4: Experimental	Drug: Fenofibrate/CoQ10 Fenofibrate 80/CoQ10 100 mg
5: Experimental	Drug: Fenofibrate/CoQ10 Fenofibrate 160mg/CoQ10 100 mg
6: Experimental	Drug: Fenofibrate/CoQ10 Fenofibrate 80 /CoQ10 200 mg
7: Experimental	Drug: Fenofibrate/CoQ10 Fenofibrate 160mg/CoQ10 200 mg

Eligibility

Ages Eligible for Study:	40 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703482

Locations

Australia
Site 001
Perth, Australia
Site 002
Fremantle, Australia
Site 003
Nedlands, Australia

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

Responsible Party:	Solvay Pharmaceuticals ( Jean Claude Ansquer )
Study ID Numbers:	CFEN0205
Study First Received:	June 20, 2008
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00703482
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by Solvay Pharmaceuticals:

Ventricular diastolic Function
Diabetes

Study placed in the following topic categories:

Metabolic Diseases
Ubiquinone
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Procetofen
Coenzyme Q10

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Vitamins
Growth Substances
Therapeutic Uses

Antilipemic Agents
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009