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

Patients With Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00703482
• Other study ID #: CFEN0205
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2008
• Last updated: June 24, 2008
• Start date: May 2003
• Est. completion date: September 2004

Study information

• Verified date: June 2008
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Patients With Type 2 Diabetes

Intervention

Drug:
• Fenofibrate/CoQ10
Fenofibrate pbo/CoQ10 placebo
• Fenofibrate/CoQ10
Fenofibrate pbo/CoQ10 200 mg
• Fenofibrate/CoQ10
Fenofibrate 160mg/CoQ10 placebo
• Fenofibrate/CoQ10
Fenofibrate 80/CoQ10 100 mg
• Fenofibrate/CoQ10
Fenofibrate 160mg/CoQ10 100 mg
• Fenofibrate/CoQ10
Fenofibrate 80 /CoQ10 200 mg
• Fenofibrate/CoQ10
Fenofibrate 160mg/CoQ10 200 mg

Locations

Country	Name	City	State
Australia	Site 002	Fremantle
Australia	Site 003	Nedlands
Australia	Site 001	Perth

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the E'/E septal ratio		End of study (V6)	No
Secondary	Severity of the LVDD		End of study (V6)	No
Secondary	Evolution of the Left atrium and right atrium volumes		End of study (V6)	No
Secondary	Evolution of the Left and right sizes		End of study (V6)	No
Secondary	Evolution of the LVEDD and LVESD		End of study (V6)	No
Secondary	Evolution of the LVEDV and LVESV		End of study (V6)	No
Secondary	Evolution of the LV mass		End of study (V6)	No
Secondary	Evolution of the LV ejection fraction		End of study (V6)	No
Secondary	Evolution of the IVRT		End of study (V6)	No
Secondary	Evolution of the tissue Doppler E'/A' ratio		End of study (V6)	No
Secondary	Evolution of the PV doppler parameters		End of study (V6)	No