Postprandial LipemiaPhase 4EZENCT00699023
Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes
A Phase 4 study testing ezetimibe tablets and simvastatin tablets in people with Postprandial Lipemia and Type 2 Diabetes, run by Federico II University at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether ezetimibe in association with statins is more effective than statins alone on postprandial lipemia in type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Postprandial Lipemia, Type 2 Diabetes
- What is being tested?
- ezetimibe tablets and simvastatin tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2008to Oct 2009
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes since at least two years
- Stable metabolic control (HbA1c<8.0%) for at least six months on diet or diet+oral hypoglycemic drugs (insulin secretagogues or metformin), not to be changed during the study period.
- BMI<30 kg/m2 and body weight stable during the last six months.
- Both sexes; only post-menopausal women.
- LDL-cholesterol >130 mg/dl, plasma triglycerides <400 mg/dl.
- No use of hypolipidemic drugs in the last three months.
Who cannot join
- Patient with renal (serum creatinine >1.5 mg/dl) or hepatic (serum transaminases >three times upper normal values) impairment.
- Patients with history of cardiovascular disease.
- Pre-menopausal women.
- Any other acute or chronic degenerative disease.
- Anemia (Hb<12 g/dl).
- Uncontrolled blood pressure.
- Use of any drugs able to interfere with the study medications
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Clinical and Experimental Medicine, Federico II University Hospital,
Naples, Naples, 80131
About this study
Official title: Effects of Ezetimibe in Association With Statins on Postprandial Lipemia in Type 2 Diabetic Patients
The purpose of this study is to determine whether ezetimibe in association with statins is more effective than statins alone on postprandial lipemia in type 2 diabetic patients.
- Conditions
- Postprandial Lipemia, Type 2 Diabetes
- Being tested
- ezetimibe tablets, simvastatin tablets, placebo
- Keywords
- postprandial lipemia, type 2 diabetes, ezetimibe, hypercholesterolemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ezetimibe tabletsDrug
ezetimibe tablets 10 mg/die
simvastatin tabletsDrug
simvastatin tablets 20 mg/die
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ezetimibe tablets 10 mg/die + simvastatin tablets 20 mg/die six weeks Receives: Drug: ezetimibe tablets; Drug: simvastatin tablets |
| 2 | Placebo comparator | placebo + simvastatin tablets 20 mg/die six weeks Receives: Drug: simvastatin tablets; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions
Measured: 6 weeks
Secondary outcomes (5)
Incremental AUC after a fat rich-meal of apo B48 concentration- marker of the number of intestinally derived lipoproteins- in chylomicron and VLDL
Measured: 6 weeks
Fasting LDL concentration
Measured: 6 weeks
Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions.
Measured: 6 weeks
Postprandial LDL size
Measured: 6 weeks
Concentration and Composition of different lipoprotein subclasses in the fasting condition.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postprandial LipemiaStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Investigators
- Gabriele Riccardi, Prof, Study chair, Department of Clinical and Experimental Medicine, Federico II University Hospital, Naples, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699023
- Sponsor's protocol ID
- 239/07
- Acronym
- EZE
- Status last verified
- Nov 2009
- First submitted
- 13 Jun 2008
- Last updated
- 4 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Rivellese AA, De Natale C, Di Marino L, Patti L, Iovine C, Coppola S, Del Prato S, Riccardi G, Annuzzi G. Exogenous and endogenous postprandial lipid abnormalities in type 2 diabetic patients with optimal blood glucose control and optimal fasting triglyceride levels. J Clin Endocrinol Metab. 2004 May;89(5):2153-9. doi: 10.1210/jc.2003-031764.
PubMed 15126535Annuzzi G, De Natale C, Iovine C, Patti L, Di Marino L, Coppola S, Del Prato S, Riccardi G, Rivellese AA. Insulin resistance is independently associated with postprandial alterations of triglyceride-rich lipoproteins in type 2 diabetes mellitus. Arterioscler Thromb Vasc Biol. 2004 Dec;24(12):2397-402. doi: 10.1161/01.ATV.0000146267.71816.30. Epub 2004 Sep 30.
PubMed 15458975Davidson MH, Toth PP. Combination therapy in the management of complex dyslipidemias. Curr Opin Lipidol. 2004 Aug;15(4):423-31. doi: 10.1097/01.mol.0000137221.16160.b9.
PubMed 15243215
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ezetimibe in Association With Statins on Postprandial Lipemia in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00699023
- Acronym / sponsor ID
- EZE / 239/07
- Conditions
- Postprandial Lipemia, Type 2 Diabetes
- Keywords
- postprandial lipemia, type 2 diabetes, ezetimibe, hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 17 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 is to determine whether ezetimibe in association with statins is more effective than statins alone on postprandial lipemia in type 2 diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ezetimibe tablets, Drug: simvastatin tabletsezetimibe tablets 10 mg/die + simvastatin tablets 20 mg/die six weeks |
| 2 | Placebo comparator | Drug: simvastatin tablets, Drug: placeboplacebo + simvastatin tablets 20 mg/die six weeks |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes since at least two years
- Stable metabolic control (HbA1c<8.0%) for at least six months on diet or diet+oral hypoglycemic drugs (insulin secretagogues or metformin), not to be changed during the study period.
- BMI<30 kg/m2 and body weight stable during the last six months.
- Both sexes; only post-menopausal women.
- LDL-cholesterol >130 mg/dl, plasma triglycerides <400 mg/dl.
Key exclusion criteria (7 listed)
- Patient with renal (serum creatinine >1.5 mg/dl) or hepatic (serum transaminases >three times upper normal values) impairment.
- Patients with history of cardiovascular disease.
- Pre-menopausal women.
- Any other acute or chronic degenerative disease.
- Anemia (Hb<12 g/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 |
|---|---|---|
| ezetimibe tabletsezetimibe tablets 10 mg/die | Drug | 1 |
| simvastatin tabletssimvastatin tablets 20 mg/die | Drug | 1, 2 |
| placeboplacebo | Drug | 2 |
Primary outcome
Incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions
Time frame: 6 weeks
5 secondary outcomes
Incremental AUC after a fat rich-meal of apo B48 concentration- marker of the number of intestinally derived lipoproteins- in chylomicron and VLDL
Time frame: 6 weeks
Fasting LDL concentration
Time frame: 6 weeks
Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions.
Time frame: 6 weeks
Postprandial LDL size
Time frame: 6 weeks
Concentration and Composition of different lipoprotein subclasses in the fasting condition.
Time frame: 6 weeks
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 4 Nov 2009.
- Background: PubMed 15126535Rivellese AA, De Natale C, Di Marino L, Patti L, Iovine C, Coppola S, Del Prato S, Riccardi G, Annuzzi G. Exogenous and endogenous postprandial lipid abnormalities in type 2 diabetic patients with optimal blood glucose control and optimal fasting triglyceride levels. J Clin Endocrinol Metab. 2004 May;89(5):2153-9. doi: 10.1210/jc.2003-031764.
- Background: PubMed 15458975Annuzzi G, De Natale C, Iovine C, Patti L, Di Marino L, Coppola S, Del Prato S, Riccardi G, Rivellese AA. Insulin resistance is independently associated with postprandial alterations of triglyceride-rich lipoproteins in type 2 diabetes mellitus. Arterioscler Thromb Vasc Biol. 2004 Dec;24(12):2397-402. doi: 10.1161/01.ATV.0000146267.71816.30. Epub 2004 Sep 30.
- Background: PubMed 15243215Davidson MH, Toth PP. Combination therapy in the management of complex dyslipidemias. Curr Opin Lipidol. 2004 Aug;15(4):423-31. doi: 10.1097/01.mol.0000137221.16160.b9.
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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.
Gabriele Riccardi, Prof study chair
Department of Clinical and Experimental Medicine, Federico II University Hospital, Naples, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ezetimibe tablets and simvastatin tablets in people with Postprandial Lipemia and Type 2 Diabetes, run by Federico II University at 1 site in Italy.
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 6 inclusion and 7 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 4 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00699023, which also lists 3 linked publications.
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 4 Nov 2009.