AzTrials
AzTrials

Diabetes Mellitus Type 2Phase 4EZENCT01384058

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

A Phase 4 study testing ezetimibe, simvastatin and Ezetimibe 10/Simvastatin 20 in people with Diabetes Mellitus Type 2 and Hypercholesterolemia, run by University Hospital Freiburg at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
ezetimibe, simvastatin and Ezetimibe 10/Simvastatin 20
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
2 sitesGermany
Study dates
Nov 2007to Jun 2010
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Institut für Stoffwechselforschung

    Frankfurt, Germany, 60322

  • Stephan Jacob, MD

    Villingen-Schwenningen, Germany, 78048

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
ezetimibe, simvastatin, Ezetimibe 10/Simvastatin 20
Keywords
atherogenic lipoprotein, cardiovascular disease, coronary artery disease, type 2 diabetes, small, dense LDL
Medical subject headings
Diabetes Mellitus, Type 2, Hypercholesterolemia, Cardiovascular Diseases, Coronary Artery Disease, Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ezetimibeDrug

    Also called Ezetrol 10 mg

    ezetimibe 10 mg per day for six weeks

  • simvastatinDrug

    Also called Zocor MSD

    Simvastatin 20 mg per day for six weeks

  • Ezetimibe 10/Simvastatin 20Drug

    Also called Inegy 10/20

    Ezetimibe 10mg/Simvastatin 20mg per day for six weeks

Study groups in NCT01384058
Study groupRoleWhat they receive
Ezetimibe 10mg/dActive comparatorintake of ezetimibe 10mg per day for six weeks after wash-out
Receives: Drug: ezetimibe
Simvastatin 20 mg per dayActive comparatorintake of simvastatin 20 mg per day for six weeks after wash-out
Receives: Drug: simvastatin
Ezetimibe 10 mg/d and Simvastatin 20mg/dActive comparatorintake of ezetimibe 10 mg and simvastatin 20 mg per day for six weeks after wash-out
Receives: Drug: Ezetimibe 10/Simvastatin 20

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: baseline and 6 weeks

Secondary outcomes (4)

  1. Change of the concentrations of Total Cholesterol

    Measured: baseline and 6 weeks

  2. Change of the concentrations of Low Densitiy Lipoprotein (LDL) -Cholesterol

    Measured: baseline and 6 weeks

  3. Change of the concentrations of High Density Lipoprotein (HDL) -Cholesterol

    Measured: baseline and 6 weeks

  4. Change of the concentrations of triglycerides

    Measured: baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2011 (estimated)
  2. Study startNov 2007
  3. Primary completionMay 2010
  4. Study completionJun 2010

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01384058
Sponsor's protocol ID
442006
Other IDs
2006-005906-30
Acronym
EZE
Status last verified
Jun 2012
First submitted
23 Jun 2011
Last updated
19 Jun 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Haffner SM, Lehto S, Ronnemaa T, Pyorala K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998 Jul 23;339(4):229-34. doi: 10.1056/NEJM199807233390404.

    PubMed 9673301

  • Reaven GM, Chen YD, Jeppesen J, Maheux P, Krauss RM. Insulin resistance and hyperinsulinemia in individuals with small, dense low density lipoprotein particles. J Clin Invest. 1993 Jul;92(1):141-6. doi: 10.1172/JCI116541.

    PubMed 8325978

  • Austin MA, Edwards KL. Small, dense low density lipoproteins, the insulin resistance syndrome and noninsulin-dependent diabetes. Curr Opin Lipidol. 1996 Jun;7(3):167-71. doi: 10.1097/00041433-199606000-00010.

    PubMed 8818515

  • Winkler K, Abletshauser C, Hoffmann MM, Friedrich I, Baumstark MW, Wieland H, Marz W. Effect of fluvastatin slow-release on low density lipoprotein (LDL) subfractions in patients with type 2 diabetes mellitus: baseline LDL profile determines specific mode of action. J Clin Endocrinol Metab. 2002 Dec;87(12):5485-90. doi: 10.1210/jc.2002-020370.

    PubMed 12466341

  • Austin MA, King MC, Vranizan KM, Krauss RM. Atherogenic lipoprotein phenotype. A proposed genetic marker for coronary heart disease risk. Circulation. 1990 Aug;82(2):495-506. doi: 10.1161/01.cir.82.2.495.

    PubMed 2372896

  • Nigon F, Lesnik P, Rouis M, Chapman MJ. Discrete subspecies of human low density lipoproteins are heterogeneous in their interaction with the cellular LDL receptor. J Lipid Res. 1991 Nov;32(11):1741-53.

    PubMed 1770294

  • Dejager S, Bruckert E, Chapman MJ. Dense low density lipoprotein subspecies with diminished oxidative resistance predominate in combined hyperlipidemia. J Lipid Res. 1993 Feb;34(2):295-308.

    PubMed 8429263

  • Anber V, Griffin BA, McConnell M, Packard CJ, Shepherd J. Influence of plasma lipid and LDL-subfraction profile on the interaction between low density lipoprotein with human arterial wall proteoglycans. Atherosclerosis. 1996 Aug 2;124(2):261-71. doi: 10.1016/0021-9150(96)05842-x.

    PubMed 8830938

  • Nordestgaard BG, Nielsen LB. Atherosclerosis and arterial influx of lipoproteins. Curr Opin Lipidol. 1994 Aug;5(4):252-7. doi: 10.1097/00041433-199408000-00002.

    PubMed 7981955

  • Griffin BA, Freeman DJ, Tait GW, Thomson J, Caslake MJ, Packard CJ, Shepherd J. Role of plasma triglyceride in the regulation of plasma low density lipoprotein (LDL) subfractions: relative contribution of small, dense LDL to coronary heart disease risk. Atherosclerosis. 1994 Apr;106(2):241-53. doi: 10.1016/0021-9150(94)90129-5.

    PubMed 8060384

  • Gardner CD, Fortmann SP, Krauss RM. Association of small low-density lipoprotein particles with the incidence of coronary artery disease in men and women. JAMA. 1996 Sep 18;276(11):875-81.

    PubMed 8782636

  • Stampfer MJ, Krauss RM, Ma J, Blanche PJ, Holl LG, Sacks FM, Hennekens CH. A prospective study of triglyceride level, low-density lipoprotein particle diameter, and risk of myocardial infarction. JAMA. 1996 Sep 18;276(11):882-8.

    PubMed 8782637

  • Lamarche B, Tchernof A, Moorjani S, Cantin B, Dagenais GR, Lupien PJ, Despres JP. Small, dense low-density lipoprotein particles as a predictor of the risk of ischemic heart disease in men. Prospective results from the Quebec Cardiovascular Study. Circulation. 1997 Jan 7;95(1):69-75. doi: 10.1161/01.cir.95.1.69.

    PubMed 8994419

  • Berneis KK, Krauss RM. Metabolic origins and clinical significance of LDL heterogeneity. J Lipid Res. 2002 Sep;43(9):1363-79. doi: 10.1194/jlr.r200004-jlr200.

    PubMed 12235168

  • Blake GJ, Otvos JD, Rifai N, Ridker PM. Low-density lipoprotein particle concentration and size as determined by nuclear magnetic resonance spectroscopy as predictors of cardiovascular disease in women. Circulation. 2002 Oct 8;106(15):1930-7. doi: 10.1161/01.cir.0000033222.75187.b9.

    PubMed 12370215

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ezetimibe, simvastatin and Ezetimibe 10/Simvastatin 20 in people with Diabetes Mellitus Type 2 and Hypercholesterolemia, run by University Hospital Freiburg at 2 sites in Germany.

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 13 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 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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 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?

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). 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 NCT01384058, which also lists 22 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 19 Jun 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in