Platelet Function in Diabetic Patients With and Without Renal Impairment, and the Effects of Lipid Lowering Treatment
PLAUDIT
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 diabetes-mellitus
Started Jan 2006
Longer than P75 for phase_4 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 17, 2009
CompletedFirst Posted
Study publicly available on registry
December 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedMarch 1, 2021
February 1, 2021
6.4 years
December 17, 2009
February 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Compare the effects of simvastatin + ezetimibe with those of simvastatin alone, on thrombogenic mechanisms, in patients with diabetes mellitus type 2.
6 weeks, 14-18 weeks, 22-24 weeks
Secondary Outcomes (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.
6 weeks, 14-18 weeks, 22-24 weeks
Study Arms (1)
simvastatin + ezetimibe
EXPERIMENTALCross-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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Danderyd Hospitalcollaborator
Study Sites (1)
Department of Medicine, Clinical Pharmacology Unit, Karolinska University Hospital (Solna)
Stockholm, 171 76, Sweden
Related Publications (3)
Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
PMID: 38018702DERIVEDAlmquist 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.
PMID: 24720535DERIVEDAlmquist 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.
PMID: 22700717DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Hjemdahl, MD, PhD
Dept. of Medicine, Clinical Pharmacology Unit, Karolinska University Hospital (Solna), Stockholm, Sweden
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 17, 2009
First Posted
December 18, 2009
Study Start
January 1, 2006
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
March 1, 2021
Record last verified: 2021-02