Influence on the coronary Microcirculation and on myocArdial perfusion Reserve of Niaspan given IN addition to simvastatin in diabEtic patients - MARINE

• Conditions: Diabetic patients at high risk for CVD

• Registration Number: EUCTR2006-000569-13-DE
• Lead Sponsor: Cardioangiologisches Centrum Bethanien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

· Age > 18 years
· Male or post-menopausal female patients (no HRT)
· Diabetes mellitus type 2, controlled by metformin and/or sulphonylurea
· HDL <50mg/dl
· LDL < 160mg/dl
· TG < 400mg/dl
· BMI < 30
· HbA1c < 8%
· Normal renal function (creatinine <0.015g/l
· Normal liver blood tests (AST, ALT <1.5x ULN)
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

· Prior myocardial infarction, PTCA or CABG
· Severe stenosis that needs intervention
· Secondary causes of hyperlipidemia (except type 2 diabetes)
· Cutaneous and/or tendinous xanthoma
· Non-controlled hypertension (SBP > 160 and/or DBP>90 mm Hg)
· Use of non-selective beta blockers (propanolol)
· Past or current peptic ulcers
· Insulin treatment
· Regular use of corticosteroids
· Drugs able to modify oxidation parameters (probucol, vitamin E, vitamin C)
· Smoking
· Daily alcohol consumption > 40g

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To assess the influence of a 12 months therapy with Niaspan on top of simvastatin on myocardial perfusion at rest and during infusion of adenosine in diabetic patients with low HDL-C. ;Primary end point(s): Difference in myocardial perfusion reserve between the two treatment groups after 12 months of treatment;Main Objective: To determine changes in myocardial perfusion reserve (adenosine minus at rest) during therapy with Niaspan on top of simvastatin in diabetic patients with low HDL-C.