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
June 24, 2008 updated by: Solvay Pharmaceuticals
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
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
278
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Fremantle, Australia
- Site 002
-
Nedlands, Australia
- Site 003
-
Perth, Australia
- Site 001
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
36 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 2
|
Fenofibrate pbo/CoQ10 placebo
Fenofibrate pbo/CoQ10 200 mg
Fenofibrate 160mg/CoQ10 placebo
Fenofibrate 80/CoQ10 100 mg
Fenofibrate 160mg/CoQ10 100 mg
Fenofibrate 80 /CoQ10 200 mg
Fenofibrate 160mg/CoQ10 200 mg
|
|
Placebo Comparator: 1
|
Fenofibrate pbo/CoQ10 placebo
Fenofibrate pbo/CoQ10 200 mg
Fenofibrate 160mg/CoQ10 placebo
Fenofibrate 80/CoQ10 100 mg
Fenofibrate 160mg/CoQ10 100 mg
Fenofibrate 80 /CoQ10 200 mg
Fenofibrate 160mg/CoQ10 200 mg
|
|
Experimental: 4
|
Fenofibrate pbo/CoQ10 placebo
Fenofibrate pbo/CoQ10 200 mg
Fenofibrate 160mg/CoQ10 placebo
Fenofibrate 80/CoQ10 100 mg
Fenofibrate 160mg/CoQ10 100 mg
Fenofibrate 80 /CoQ10 200 mg
Fenofibrate 160mg/CoQ10 200 mg
|
|
Experimental: 5
|
Fenofibrate pbo/CoQ10 placebo
Fenofibrate pbo/CoQ10 200 mg
Fenofibrate 160mg/CoQ10 placebo
Fenofibrate 80/CoQ10 100 mg
Fenofibrate 160mg/CoQ10 100 mg
Fenofibrate 80 /CoQ10 200 mg
Fenofibrate 160mg/CoQ10 200 mg
|
|
Active Comparator: 3
|
Fenofibrate pbo/CoQ10 placebo
Fenofibrate pbo/CoQ10 200 mg
Fenofibrate 160mg/CoQ10 placebo
Fenofibrate 80/CoQ10 100 mg
Fenofibrate 160mg/CoQ10 100 mg
Fenofibrate 80 /CoQ10 200 mg
Fenofibrate 160mg/CoQ10 200 mg
|
|
Experimental: 6
|
Fenofibrate pbo/CoQ10 placebo
Fenofibrate pbo/CoQ10 200 mg
Fenofibrate 160mg/CoQ10 placebo
Fenofibrate 80/CoQ10 100 mg
Fenofibrate 160mg/CoQ10 100 mg
Fenofibrate 80 /CoQ10 200 mg
Fenofibrate 160mg/CoQ10 200 mg
|
|
Experimental: 7
|
Fenofibrate pbo/CoQ10 placebo
Fenofibrate pbo/CoQ10 200 mg
Fenofibrate 160mg/CoQ10 placebo
Fenofibrate 80/CoQ10 100 mg
Fenofibrate 160mg/CoQ10 100 mg
Fenofibrate 80 /CoQ10 200 mg
Fenofibrate 160mg/CoQ10 200 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evolution of the E'/E septal ratio
Time Frame: End of study (V6)
|
End of study (V6)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Severity of the LVDD
Time Frame: End of study (V6)
|
End of study (V6)
|
|
Evolution of the Left atrium and right atrium volumes
Time Frame: End of study (V6)
|
End of study (V6)
|
|
Evolution of the Left and right sizes
Time Frame: End of study (V6)
|
End of study (V6)
|
|
Evolution of the LVEDD and LVESD
Time Frame: End of study (V6)
|
End of study (V6)
|
|
Evolution of the LVEDV and LVESV
Time Frame: End of study (V6)
|
End of study (V6)
|
|
Evolution of the LV mass
Time Frame: End of study (V6)
|
End of study (V6)
|
|
Evolution of the LV ejection fraction
Time Frame: End of study (V6)
|
End of study (V6)
|
|
Evolution of the IVRT
Time Frame: End of study (V6)
|
End of study (V6)
|
|
Evolution of the tissue Doppler E'/A' ratio
Time Frame: End of study (V6)
|
End of study (V6)
|
|
Evolution of the PV doppler parameters
Time Frame: End of study (V6)
|
End of study (V6)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2003
Primary Completion (Actual)
September 1, 2004
Study Completion (Actual)
September 1, 2004
Study Registration Dates
First Submitted
June 20, 2008
First Submitted That Met QC Criteria
June 20, 2008
First Posted (Estimate)
June 23, 2008
Study Record Updates
Last Update Posted (Estimate)
June 25, 2008
Last Update Submitted That Met QC Criteria
June 24, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Micronutrients
- Hypolipidemic Agents
- Lipid Regulating Agents
- Vitamins
- Fenofibrate
- Coenzyme Q10
- Ubiquinone
Other Study ID Numbers
- CFEN0205
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