Platelet Function in Diabetic Patients With and Without Renal Impairment, and the Effects of Lipid Lowering Treatment (PLAUDIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01035320
Recruitment Status : Completed
First Posted : December 18, 2009
Last Update Posted : February 28, 2011
Danderyd Hospital
Information provided by:
Karolinska University Hospital

Brief Summary:
The purpose of this study is compare the effects of simvastatin+ezetimibe with those of simvastatin alone on platelet activity, platelet-leukocyte interactions and inflammatory variables in diabetic patients with or without impaired renal function.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Renal Impairment Drug: Ezetimibe Phase 4

Detailed Description:
A detailed study protocol is available.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Platelet Function in Diabetic Patients With and Without Renal Impairment, and the Effects of Lipid Lowering Treatment
Study Start Date : January 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: simvastatin + ezetimibe
Cross-over study with placebo only run-in period. All patients participate in this arm with simvastatin + ezetimibe either as first treatment period (8-10 weeks)or second treatment period (8-10 weeks). The primary comparison is ezetimibe vs. placebo on top of simvastatin. A secondary comparison will be simvastatin vs. placebo run-in.
Drug: Ezetimibe
After a placebo only run-in period patients (two groups) are treated with simvastatin + ezetimibe and simvastatin + placebo in a cross-over trial. Ezetimibe effects on top of simvastatin will be evaluated as the primary aim; simvastatin effects compared to run-in on placebo will be evaluated as a secondary aim.
Other Names:
  • Simvastatin
  • Ezetrol

Primary Outcome Measures :
  1. Compare the effects of simvastatin + ezetimibe with those of simvastatin alone, on thrombogenic mechanisms, in patients with diabetes mellitus type 2. [ Time Frame: 6 weeks, 14-18 weeks, 22-24 weeks ]

Secondary Outcome Measures :
  1. Compare effects of simvastatin alone with those of placebo on thrombogenic mechanisms. Compare the effects of simvast. + ezetim. with those of simvast. alone on inflammatory variables. Assess how the treatment effect relate to renal function. [ Time Frame: 6 weeks, 14-18 weeks, 22-24 weeks ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diabetes mellitus type 1 or type 2
  • With or without established microalbuminuria (albumin-to-creatinine ratio (ACR)2,5-25 mg/mmol for men, and 3,5-25 mg/mmol for women, according to ISH and ESC recommended criteria)
  • Glomerular filtration rate (GFR) between 15-60 ml/min/1.73m2 (measured the last 6 months) or GFR >75ml/min/1.73m2. The abbreviated Modification of Diet in Renal Disease (MDRD) equation will be used to calculate GFR.
  • Age 18-80 years

Exclusion Criteria:

  • Definite history of myocardial infarction, coronary revascularisation procedure or stroke. (i.e, a strong clinical indication for statin treatment)
  • Functioning renal transplant, or living donor-related transplant planned.
  • Patients on dialysis.
  • Poor metabolic control, i.e HbA1c > 9%
  • Definite history of chronic liver disease, or abnormal liver function (i.e ALT >1,5 x ULN or, if ALT not available, AST > 1,5 x ULN).
  • Evidence of active inflammatory muscle disease (e.g dermatomyositis, polymyositis), or CK>3 x ULN;
  • Definite previous adverse reaction to a statin or to ezetimibe
  • Definite previous adverse reaction to acetylsalicylic acid.
  • Definite previous adverse reaction to an ACE-inhibitor.
  • Need for concomitant treatment with a strong inhibitor of CYP3A4, such as itrokonazole, ketokonazole, erythromycin, clarithromycin, HIV-protease inhibitors or nefazodone (i.e. agents that may markedly elevate simvastatin levels).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01035320

Department of Medicine, Clinical Pharmacology Unit, Karolinska University Hospital (Solna)
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska University Hospital
Danderyd Hospital
Principal Investigator: Paul Hjemdahl, MD, PhD Dept. of Medicine, Clinical Pharmacology Unit, Karolinska University Hospital (Solna), Stockholm, Sweden

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Paul Hjemdahl, MD, PhD, professor, Clinical Pharmacology Unit, Dept of Medicine, Karolinska University Hospital/Solna Identifier: NCT01035320     History of Changes
Other Study ID Numbers: EudraCT 2004-004416-22 DMK001
First Posted: December 18, 2009    Key Record Dates
Last Update Posted: February 28, 2011
Last Verified: December 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors