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

Primary Purpose

Diabetes Mellitus, Impaired Renal Function

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Ezetimibe
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Department of Medicine, Clinical Pharmacology Unit, Karolinska University Hospital (Solna)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

simvastatin + ezetimibe

Arm Description

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.

Outcomes

Primary Outcome Measures

Compare the effects of simvastatin + ezetimibe with those of simvastatin alone, on thrombogenic mechanisms, in patients with diabetes mellitus type 2.

Secondary Outcome Measures

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.

Full Information

First Posted
December 17, 2009
Last Updated
February 25, 2021
Sponsor
Karolinska Institutet
Collaborators
Danderyd Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01035320
Brief Title
Platelet Function in Diabetic Patients With and Without Renal Impairment, and the Effects of Lipid Lowering Treatment
Acronym
PLAUDIT
Official Title
Platelet Function in Diabetic Patients With and Without Renal Impairment, and the Effects of Lipid Lowering Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Danderyd Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
A detailed study protocol is available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Impaired Renal Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
simvastatin + ezetimibe
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Other Intervention Name(s)
Simvastatin, Ezetrol
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Hjemdahl, MD, PhD
Organizational Affiliation
Dept. of Medicine, Clinical Pharmacology Unit, Karolinska University Hospital (Solna), Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Clinical Pharmacology Unit, Karolinska University Hospital (Solna)
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24720535
Citation
Almquist T, Jacobson SH, Mobarrez F, Nasman P, Hjemdahl P. Lipid-lowering treatment and inflammatory mediators in diabetes and chronic kidney disease. Eur J Clin Invest. 2014;44(3):276-84. doi: 10.1111/eci.12230. Epub 2014 Jan 22.
Results Reference
derived
PubMed Identifier
22700717
Citation
Almquist T, Jacobson SH, Lins PE, Farndale RW, Hjemdahl P. Effects of lipid-lowering treatment on platelet reactivity and platelet-leukocyte aggregation in diabetic patients without and with chronic kidney disease: a randomized trial. Nephrol Dial Transplant. 2012 Sep;27(9):3540-6. doi: 10.1093/ndt/gfs183. Epub 2012 Jun 13.
Results Reference
derived

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

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