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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000569-13-DE

Enrollment

Registered

2006-08-29

Start date

2006-04-21

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic patients at high risk for CVD

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: nicotinic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Tablet Rout

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: · Age > 18 years · Male or post-menopausal female patients (no HRT) · Diabetes mellitus type 2, controlled by metformin and/or sulphonylurea · HDL =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026