Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe

This study has been completed.
Information provided by (Responsible Party):
Gottfried Rudofsky, University of Heidelberg
ClinicalTrials.gov Identifier:
First received: August 23, 2011
Last updated: August 25, 2011
Last verified: August 2011

Lowering LDL cholesterol by statins has been proven to be associated with reduction of proinflammatory regulators e.g. activation of the transcription factor NF-ĸB. Up to now the effects of newer cholesterol lowering agents such as ezetemibe with respect to their anti-inflammatory potential are less intensively studied. Therefore the investigators analyzed whether equipotent LDL-lowering therapy with simvastatin alone and in combination with ezetimibe have comparable effects on NF-ĸB-activation in peripheral blood mononuclear cells (PBMCs) of patients with type 2 diabetes.

Condition Intervention
Type 2 Diabetes
Drug: Simvastatin 80 mg
Drug: Sim10/Eze10
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe

Resource links provided by NLM:

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • NF-kappa B binding activity [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    The binding activity of nuclear transcription factor nuclear factor kappa B (NF-kappa B)will be measured in patients with type 2 diabetes before and after 8 weeks while under study treatment. Analysis will be done with electrophoretic mobility shift assay. Nuclear extract, which is necessary, will be generated from peripheral blood mononuclear cells.

Secondary Outcome Measures:
  • Inflammatory markers [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    Blood levels of high sensitivity CRP and interleukin-6 will be measured before study start and after 8 weeks while under study medication.

Enrollment: 31
Study Start Date: April 2004
Study Completion Date: August 2011
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Treatment with placebo over 8 weeks
Drug: Placebo
treatment with placebo over 8 weeks
Active Comparator: Simvastatin 80 mg
treatment with 80 mg of simvastatin over 8 weeks
Drug: Simvastatin 80 mg
treatment with 80 mg of simvastatin over a period of 8 weeks
Other Names:
  • zocor
  • simvastatin
Active Comparator: Sim10/Eze10
treatment with 10 mg of simvastatin in combination with 10 mg ezetimibe over 8 weeks
Drug: Sim10/Eze10
treatment with combination of simvastatin 10 mg and ezetimibe 10 mg
Other Name: inegy


Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 35 to 80 years old
  • type 2 diabetes
  • HbA1c value between 6.0 % and 9.0 %
  • elevated LDL-c values > 100 mg/dl with no lipid lowering treatment within the last six month

Exclusion Criteria:

  • refused informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424891

University Hospital of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Principal Investigator: Gottfried Rudofsky, MD University Hospital of Heidelberg
  More Information

No publications provided

Responsible Party: Gottfried Rudofsky, Principal investigator, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01424891     History of Changes
Other Study ID Numbers: SimEze
Study First Received: August 23, 2011
Last Updated: August 25, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 14, 2014