Dyslipidemia/Glucose Metabolism DisorderPhase 2/3NCT00349128
Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes
A Phase 2/3 study testing fenofibrate and metformin combination (drug) in people with Dyslipidemia/Glucose Metabolism Disorder, run by Solvay Pharmaceuticals at 51 sites in 3 countries.
Trial summary
The primary objective was to assess the effect of 3-month treatment of low and standard doses of fenofibrate in combination with stable dose of metformin on fasting triglycerides levels in patients with type 2 diabetes and dyslipidemia. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Dyslipidemia/Glucose Metabolism Disorder
- What is being tested?
- fenofibrate and metformin combination (drug)
- How many people
- 382 participants
- Where
- 51 sitesin 3 countries
- Study dates
- Jan 2004to not given
- Phase
- Phase 2/3
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
Who cannot join
- Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c ≥ 10 % - Fasting plasma glucose > 300 mg/dL - Triglycerides > 500 mg/dL
Trial locations and contacts
51 sites in 3 countries.
51 sites in 3 countries
United Kingdom35 sites
Site 35
Acomb
Site 21
Atherstone
Site 14
Balsall Common
Site 32
Bangor
Site 23
Barry
Site 36
Basingstoke
Site 8
Bexhill-on-Sea
Site 20
Camberley
Site 22
Chesterfield
Site 10
Chippenham
Site 13
Coventry
Site 31
Doncaster
Site 15
Downpatrick
Site 17
Ely
Site 4
Ely
Site 11
Fife
Site 1
Frome
Site 16
Harrow
Site 5
Hastings
Site 26
Haverfordwest
Site 19
Keresley End
Site 9
Kingswood
Site 25
Newtownabbey
Site 33
Northampton
Site 28
Odiham
Site 3
Paignton
Site 12
Peterborough
Site 7
Randalstown
Site 27
Slough
Site 6
Soham
Site 2
South Glamorgan
Site 34
Stratford-upon-Avon
Site 29
Swindon
Site 30
Trowbridge
Site 18
Yaxley
Ukraine12 sites
Site 111
Dnipropetrovsk
Site 113
Dnipropetrovsk
Site 108
Kharkiv
Site 109
Kharkiv
Site 101
Kyiv
Site 102
Kyiv
Site 103
Kyiv
Site 104
Kyiv
Site 105
Kyiv
Site 106
Kyiv
Site 107
Kyiv
Site 112
Zaporizhya
About this study
Official title: A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Low and Standard Doses of Fenofibrate in Combination With Metformin on the Lipid Profile in Patients With Type 2 Diabetes and Dyslipidemia.
The primary objective was to assess the effect of 3-month treatment of low and standard doses of fenofibrate in combination with stable dose of metformin on fasting triglycerides levels in patients with type 2 diabetes and dyslipidemia.
- Conditions
- Dyslipidemia/Glucose Metabolism Disorder
- Being tested
- fenofibrate and metformin combination (drug)
- Keywords
- Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
- Medical subject headings
- Dyslipidemias, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenofibrate and metformin combination (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting triglycerides.
Secondary outcomes (1)
Assessment of lipid and glucose metabolisms.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyslipidemia/Glucose Metabolism DisorderStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 382 participants
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
- NCT00349128
- Sponsor's protocol ID
- C LF23-0121 03 01
- Status last verified
- Aug 2007
- First submitted
- 5 Jul 2006
- Last updated
- 3 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Low and Standard Doses of Fenofibrate in Combination With Metformin on the Lipid Profile in Patients With Type 2 Diabetes and Dyslipidemia.
- ClinicalTrials.gov ID
- NCT00349128
- Acronym / sponsor ID
- C LF23-0121 03 01
- Conditions
- Dyslipidemia/Glucose Metabolism Disorder
- Keywords
- Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- First posted
- 6 Jul 2006 (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 primary objective was to assess the effect of 3-month treatment of low and standard doses of fenofibrate in combination with stable dose of metformin on fasting triglycerides levels in patients with type 2 diabetes and dyslipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes mellitus
Key exclusion criteria (1 listed)
- Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c ≥ 10 % - Fasting plasma glucose > 300 mg/dL - Triglycerides > 500 mg/dL
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 and metformin combination (drug) | Drug | – |
Primary outcome
Change in fasting triglycerides.
1 secondary outcome
Assessment of lipid and glucose metabolisms.
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 3 Sep 2007.
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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
51 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing fenofibrate and metformin combination (drug) in people with Dyslipidemia/Glucose Metabolism Disorder, run by Solvay Pharmaceuticals at 51 sites in 3 countries.
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 1 inclusion and 1 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 3 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United Kingdom, Ukraine, Poland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in fasting triglycerides.. 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 3 Sep 2007.