Effect of Ezetimibe or Simvastatin or Both on Low Densitiy Lipoprotein -Subfractions in Patients With Type 2 Diabetes (EZE)

June 18, 2012 updated by: Karl Winkler, University Hospital Freiburg

The Effect of Ezetimibe 10 mg, Simvastatin 20 mg and the Combination of Simvastatin 20 mg Plus 10 mg Ezetimibe on Low Density Lipoprotein (LDL)-Subfractions in Patients With Type 2 Diabetes

It is of interest how ezetimibe alone or in combination with statin may influence atherogenic dense Low Density Lipoprotein (dLDL) in patients with type 2 diabetes mellitus. The primary objective of this study will be whether there is a change of the concentrations of Apolipoprotein B (ApoB) in dLDL from baseline in each of the 3 treatment groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The selective cholesterol resorption inhibitor ezetimibe belongs to a new class of cholesterol lowering drugs. It is of interest how ezetimibe alone or in combination with statin may influence atherogenic dense Low Density Lipoprotein (dLDL) in patients with type 2 diabetes mellitus.

The primary objective of this study will be whether there is a change of the concentrations of Apolipoprotein B (ApoB) in dLDL from baseline in each of the 3 treatment groups. The comparison between treatment groups is exploratory due to insufficient power to detect any change between treatments.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60322
        • Institut für Stoffwechselforschung
      • Villingen-.Schwenningen, Germany, 78048
        • Stephan Jacob, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • men > 18 and ≤ 75 years
  • post-menopausal women ≤ 75 years (follicle stimulating hormone (FSH) >30 mIU/ml, women > 60 years FSH > 20 mIU/ml )
  • well controlled diabetes mellitus type II (glycohaemoglobin ≤ 8,0 %)
  • LDL-cholesterol ≤ 160 mg/dl
  • LDL-subfractions: concentration of apoB-100 in dLDL (LDL-5 und LDL-6) > 25 mg/dl
  • written informed consent

Exclusion Criteria:

  • participation in a clinical trial within the last 30 d before screening- visit
  • patient is unable to give written informed consent
  • Body mass index <15 kg/m² and > 35 kg/m²
  • clinical atherosclerotic disease (coronary heart disease, peripheral artery disease, carotid artery disease)
  • malignoma
  • uncontrolled arterial hypertension (>160/>100 mmHg)
  • clinically relevant disease of liver and/or kidneys
  • clinically relevant endocrinally or hematologic problems
  • allergy to study medication (Ezetimibe and/or Simvastatin)
  • alcohol- or drug abuse
  • laboratory: alanine aminotransferase, aspartate aminotransferase, total bilirubin > 3 x ULN, creatine kinase > 5 x ULN
  • Concurrent treatment with potent CYP3A4-inhibitors (e.g. itraconazole, ketoconazole, HIV-protease-inhibitors, erythromycin, clarithromycin, telithromycin und nefazodone)
  • other relevant diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ezetimibe 10mg/d
intake of ezetimibe 10mg per day for six weeks after wash-out
Drug: ezetimibe
ezetimibe 10 mg per day for six weeks
Other Names:
  • Ezetrol 10 mg
Active Comparator: Simvastatin 20 mg per day
intake of simvastatin 20 mg per day for six weeks after wash-out
Drug: simvastatin
Simvastatin 20 mg per day for six weeks
Other Names:
  • Zocor MSD
Active Comparator: Ezetimibe 10 mg/d and Simvastatin 20mg/d
intake of ezetimibe 10 mg and simvastatin 20 mg per day for six weeks after wash-out
Drug: Ezetimibe 10/Simvastatin 20
Ezetimibe 10mg/Simvastatin 20mg per day for six weeks
Other Names:
  • Inegy 10/20

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the concentration of apolipoprotein B (ApoB) in dense Low Densitiy Lipoprotein (dLDL) from baseline with ezetimibe, simvastatin or the combination of both drugs
Time Frame: baseline and 6 weeks
multicentre, randomized, open-label study investigation in 6-week effect of ezetimibe (10mg/d), simvastatin (20mg/d) or combination of ezetimibe 10mg/simvastatin 20mg/d on concentrations of dLDL separated by preparative gradient ultracentrifugation in patients with type 2 diabetes.
baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of the concentrations of Total Cholesterol
Time Frame: baseline and 6 weeks
baseline and 6 weeks
Change of the concentrations of Low Densitiy Lipoprotein (LDL) -Cholesterol
Time Frame: baseline and 6 weeks
baseline and 6 weeks
Change of the concentrations of High Density Lipoprotein (HDL) -Cholesterol
Time Frame: baseline and 6 weeks
baseline and 6 weeks
Change of the concentrations of triglycerides
Time Frame: baseline and 6 weeks
baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Freiburg

Collaborators

Essex Pharma GmbH

Investigators

  • Principal Investigator: Karl Winkler, MD, University Hospital Freiburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

June 27, 2011

First Posted (Estimate)

June 28, 2011

Study Record Updates

Last Update Posted (Estimate)

June 19, 2012

Last Update Submitted That Met QC Criteria

June 18, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 442006
  • 2006-005906-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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