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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gottfried Rudofsky, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01424891
First received: August 23, 2011
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

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
Inflammation
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

  Eligibility

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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01424891

Locations
Germany
University Hospital of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
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
Inflammation
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Simvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014