Patients With Type 2 DiabetesPhase 2NCT00703482
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
A Phase 2 study testing Fenofibrate/CoQ10 in people with Patients With Type 2 Diabetes, run by Solvay Pharmaceuticals at 3 sites in Australia.
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 Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Patients With Type 2 Diabetes
- What is being tested?
- Fenofibrate/CoQ10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- 3 sitesAustralia
- Study dates
- May 2003to Sep 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged from 40 to 79 years
- Patients with pre-existing T2DM
- HbA1C <9%
- Written informed consent
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
About this study
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
- Conditions
- Patients With Type 2 Diabetes
- Being tested
- Fenofibrate/CoQ10
- Keywords
- Ventricular diastolic Function, Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenofibrate/CoQ10Drug
Fenofibrate pbo/CoQ10 placebo
Fenofibrate/CoQ10Drug
Fenofibrate pbo/CoQ10 200 mg
Fenofibrate/CoQ10Drug
Fenofibrate 160mg/CoQ10 placebo
Fenofibrate/CoQ10Drug
Fenofibrate 80/CoQ10 100 mg
Fenofibrate/CoQ10Drug
Fenofibrate 160mg/CoQ10 100 mg
Fenofibrate/CoQ10Drug
Fenofibrate 80 /CoQ10 200 mg
Fenofibrate/CoQ10Drug
Fenofibrate 160mg/CoQ10 200 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Fenofibrate/CoQ10 |
| 2 | Active comparator | Not described Receives: Drug: Fenofibrate/CoQ10 |
| 3 | Active comparator | Not described Receives: Drug: Fenofibrate/CoQ10 |
| 4 | Experimental | Not described Receives: Drug: Fenofibrate/CoQ10 |
| 5 | Experimental | Not described Receives: Drug: Fenofibrate/CoQ10 |
| 6 | Experimental | Not described Receives: Drug: Fenofibrate/CoQ10 |
| 7 | Experimental | Not described Receives: Drug: Fenofibrate/CoQ10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the E'/E septal ratio
Measured: End of study (V6)
Secondary outcomes (10)
Severity of the LVDD
Measured: End of study (V6)
Evolution of the Left atrium and right atrium volumes
Measured: End of study (V6)
Evolution of the Left and right sizes
Measured: End of study (V6)
Evolution of the LVEDD and LVESD
Measured: End of study (V6)
Evolution of the LVEDV and LVESV
Measured: End of study (V6)
Evolution of the LV mass
Measured: End of study (V6)
Evolution of the LV ejection fraction
Measured: End of study (V6)
Evolution of the IVRT
Measured: End of study (V6)
Evolution of the tissue Doppler E'/A' ratio
Measured: End of study (V6)
Evolution of the PV doppler parameters
Measured: End of study (V6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startMay 2003
- Primary completionSep 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703482
- Sponsor's protocol ID
- CFEN0205
- Status last verified
- Jun 2008
- First submitted
- 20 Jun 2008
- Last updated
- 25 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00703482
- Acronym / sponsor ID
- CFEN0205
- Conditions
- Patients With Type 2 Diabetes
- Keywords
- Ventricular diastolic Function, Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 23 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Fenofibrate/CoQ10 |
| 2 | Active comparator | Drug: Fenofibrate/CoQ10 |
| 3 | Active comparator | Drug: Fenofibrate/CoQ10 |
| 4 | Experimental | Drug: Fenofibrate/CoQ10 |
| 5 | Experimental | Drug: Fenofibrate/CoQ10 |
| 6 | Experimental | Drug: Fenofibrate/CoQ10 |
| 7 | Experimental | Drug: Fenofibrate/CoQ10 |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women aged from 40 to 79 years
- Patients with pre-existing T2DM
- HbA1C <9%
- Written informed consent
Key exclusion criteria (15 listed)
- 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
- with muscular disorders known or increase CK , or hepatic deficiency or transaminase increase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenofibrate/CoQ10Fenofibrate pbo/CoQ10 placebo | Drug | 1 |
| Fenofibrate/CoQ10Fenofibrate pbo/CoQ10 200 mg | Drug | 2 |
| Fenofibrate/CoQ10Fenofibrate 160mg/CoQ10 placebo | Drug | 1, 3 |
| Fenofibrate/CoQ10Fenofibrate 80/CoQ10 100 mg | Drug | 4 |
| Fenofibrate/CoQ10Fenofibrate 160mg/CoQ10 100 mg | Drug | 5 |
| Fenofibrate/CoQ10Fenofibrate 80 /CoQ10 200 mg | Drug | 6 |
| Fenofibrate/CoQ10Fenofibrate 160mg/CoQ10 200 mg | Drug | 7 |
Primary outcome
Evolution of the E'/E septal ratio
Time frame: End of study (V6)
10 secondary outcomes
Severity of the LVDD
Time frame: End of study (V6)
Evolution of the Left atrium and right atrium volumes
Time frame: End of study (V6)
Evolution of the Left and right sizes
Time frame: End of study (V6)
Evolution of the LVEDD and LVESD
Time frame: End of study (V6)
Evolution of the LVEDV and LVESV
Time frame: End of study (V6)
Evolution of the LV mass
Time frame: End of study (V6)
Evolution of the LV ejection fraction
Time frame: End of study (V6)
Evolution of the IVRT
Time frame: End of study (V6)
Evolution of the tissue Doppler E'/A' ratio
Time frame: End of study (V6)
Evolution of the PV doppler parameters
Time frame: End of study (V6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fenofibrate/CoQ10 in people with Patients With Type 2 Diabetes, run by Solvay Pharmaceuticals at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the E'/E septal ratio (time frame: End of study (V6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2008.