NCT00699023

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 4, 2009

Status Verified

November 1, 2009

Enrollment Period

1.3 years

First QC Date

June 13, 2008

Last Update Submit

November 3, 2009

Conditions

Postprandial LipemiaType 2 Diabetes

Keywords

postprandial lipemiatype 2 diabetesezetimibehypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Incremental AUC after a fat-rich meal of cholesterol concentration in chylomicron and VLDL fractions

    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

    6 weeks

  • Fasting LDL concentration

    6 weeks

  • Cholesterol/triglyceride ratio in postprandial chylomicrons and VLDL fractions.

    6 weeks

  • Postprandial LDL size

    6 weeks

  • Concentration and Composition of different lipoprotein subclasses in the fasting condition.

    6 weeks

Study Arms (2)

1

EXPERIMENTAL

ezetimibe tablets 10 mg/die + simvastatin tablets 20 mg/die six weeks

Drug: ezetimibe tabletsDrug: simvastatin tablets

2

PLACEBO COMPARATOR

placebo + simvastatin tablets 20 mg/die six weeks

Drug: simvastatin tabletsDrug: placebo

Interventions

ezetimibe tabletsDRUG

ezetimibe tablets 10 mg/die

1
simvastatin tabletsDRUG

simvastatin tablets 20 mg/die

12
placeboDRUG

placebo

2

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical and Experimental Medicine, Federico II University Hospital,

Naples, Naples, 80131, Italy

Location

Related Publications (3)

  • 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.

    PMID: 15126535BACKGROUND

  • Annuzzi 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.

    PMID: 15458975BACKGROUND

  • Davidson 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.

    PMID: 15243215BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypercholesterolemia

Interventions

EzetimibeSimvastatin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Gabriele Riccardi, Prof

    Department of Clinical and Experimental Medicine, Federico II University Hospital, Naples, Italy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 13, 2008

First Posted

June 17, 2008

Study Start

June 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 4, 2009

Record last verified: 2009-11

Locations

IT(1)