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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

Primary Purpose

Patients With Type 2 Diabetes

Status

Completed

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

Fenofibrate/CoQ10

About this trial

This is an interventional treatment trial for Patients With Type 2 Diabetes focused on measuring Ventricular diastolic Function, Diabetes

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Site 002
Site 003
Site 001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Evolution of the E'/E septal ratio

Secondary Outcome Measures

Severity of the LVDD

Evolution of the Left atrium and right atrium volumes

Evolution of the Left and right sizes

Evolution of the LVEDD and LVESD

Evolution of the LVEDV and LVESV

Evolution of the LV mass

Evolution of the LV ejection fraction

Evolution of the IVRT

Evolution of the tissue Doppler E'/A' ratio

Evolution of the PV doppler parameters

Full Information

NCT ID

NCT00703482

First Posted

June 20, 2008

Last Updated

June 24, 2008

Sponsor

Solvay Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00703482

Brief 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

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

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

September 2004 (Actual)

Study Completion Date

September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients With Type 2 Diabetes

Keywords

Ventricular diastolic Function, Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

278 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Fenofibrate/CoQ10

Intervention Description

Fenofibrate pbo/CoQ10 placebo

Intervention Type

Drug

Intervention Name(s)

Fenofibrate/CoQ10

Intervention Description

Fenofibrate pbo/CoQ10 200 mg

Intervention Type

Drug

Intervention Name(s)

Fenofibrate/CoQ10

Intervention Description

Fenofibrate 160mg/CoQ10 placebo

Intervention Type

Drug

Intervention Name(s)

Fenofibrate/CoQ10

Intervention Description

Fenofibrate 80/CoQ10 100 mg

Intervention Type

Drug

Intervention Name(s)

Fenofibrate/CoQ10

Intervention Description

Fenofibrate 160mg/CoQ10 100 mg

Intervention Type

Drug

Intervention Name(s)

Fenofibrate/CoQ10

Intervention Description

Fenofibrate 80 /CoQ10 200 mg

Intervention Type

Drug

Intervention Name(s)

Fenofibrate/CoQ10

Intervention Description

Fenofibrate 160mg/CoQ10 200 mg

Primary Outcome Measure Information:

Title

Evolution of the E'/E septal ratio

Time Frame

End of study (V6)

Secondary Outcome Measure Information:

Title

Severity of the LVDD

Time Frame

End of study (V6)

Title

Evolution of the Left atrium and right atrium volumes

Time Frame

End of study (V6)

Title

Evolution of the Left and right sizes

Time Frame

End of study (V6)

Title

Evolution of the LVEDD and LVESD

Time Frame

End of study (V6)

Title

Evolution of the LVEDV and LVESV

Time Frame

End of study (V6)

Title

Evolution of the LV mass

Time Frame

End of study (V6)

Title

Evolution of the LV ejection fraction

Time Frame

End of study (V6)

Title

Evolution of the IVRT

Time Frame

End of study (V6)

Title

Evolution of the tissue Doppler E'/A' ratio

Time Frame

End of study (V6)

Title

Evolution of the PV doppler parameters

Time Frame

End of study (V6)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Director Solvay

Organizational Affiliation

Solvay Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Site 002

City

Fremantle

Country

Australia

Facility Name

Site 003

City

Nedlands

Country

Australia

Facility Name

Site 001

City

Perth

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

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

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