Platelet function in diabetic patients without and with renal impairment, and the effects of lipid-lowering treatment

Phase 1

• Conditions: Diabetes mellitus type 2, without or with renal impairment

• Registration Number: EUCTR2004-004416-22-SE
• Lead Sponsor: Karolinska Institutet, Dept of Medicine, Clinical Pharmacology Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-12-06
• Study Completion: 2012-06-13
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>b) Compare the effects of simvastatin + ezetimibe with those of simvastatin alone, and simvastatin alone with placebo on inflammatory variables.<br>c) Assess how the treatment effects relate to renal function. <br>;Primary end point(s): ADP stimulated platelet P-selectin expression (flow cytometry in whole blood).<br>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.<br>