Diabetes mellitus type 2, without or with renal impairment
Conditions
Interventions
Trade Name: Zocord R
Product Name: Zocord R
Pharmaceutical Form: Tablet
INN or Proposed INN: Simvastatin
Concentration unit: mg milligram(s)
Concentration number: 40-
Pharmaceutical form of the plac
Sponsors
Karolinska Institutet, Dept of Medicine, Clinical Pharmacology Unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diabetes mellitus type 2 With or without established microalbuminuria (urinary albumin excretion of 30-299 µg/mg creatinine in a spot sample) Two out of three specimens collected within a 3-6 month period should be abnormal before the diagnosis can be settled. Glomerular filtration rate (GFR) between 15-50 ml/min (measured the last 6 months) or GFR >75ml/min. GFR will be established by 24-hour Iohexolclearence. Age 18-80 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effects of simvastatin + ezetimibe with those of simvastatin alone, on thrombogenic mechanisms, in patients with diabetes mellitus type 2.;Secondary Objective: a) Compare the effects of simvastatin alone with those of placebo (baseline data) on thrombogenic mechanisms b) Compare the effects of simvastatin + ezetimibe with those of simvastatin alone, and simvastatin alone with placebo on inflammatory variables. c) Assess how the treatment effects relate to renal function. ;Primary end point(s): ADP stimulated platelet P-selectin expression (flow cytometry in whole blood). Other flow cytometric platelet variables related to the primary end point are (a) circulating platelet-platelet aggregates, (b) circulating platelet-leukocyte aggregates, (c) single platelet counts. | — |
Countries
Sweden
Outcome results
None listed