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

Diabetes Mellitus Clinical Trial

— PLAUDIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035320
• Other study ID #: EudraCT 2004-004416-22 DMK001
• Status: Completed
• Phase: Phase 4
• Start date: January 2006
• Est. completion date: June 2012

Study information

• Verified date: February 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A detailed study protocol is available.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Impaired Renal Function
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Sweden	Department of Medicine, Clinical Pharmacology Unit, Karolinska University Hospital (Solna)	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Danderyd Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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