CompletedPhase 4ACTRN12606000466549

A study to investigate the effect of taking Nicotinic Acid Prolonged Release on abnormal artery blood vessel function in people with Type 2 diabetes who are on best-dose treatment with statin medications.

Effect of Nicotinic Acid Prolonged Release on endothelial dysfunction in subjects with Type 2 diabetes mellitus who are receiving optimal dose statin therapy

Sponsor

Professor Gerald Watts

Enrollment

50 participants

Start Date

Nov 1, 2006

Study Type

Interventional

Conditions

Subjects with Type 2 diabetes mellitus who are receiving optimal dose statin therapy.

Summary

People with diabetes and atherogenic dyslipidaemia who are treated with statin medication may still be at increased risk of cardiovascular disease and may require combination lipid regulating therapy to further reduce their risk. Endothelial dysfunction and increased arterial stiffness are present in early diabetic vascular disease and may be useful surrogate endpoints for cardiovascular risk. This 23 week, randomised single-blind, controlled, parallel group study in 50 participants with diabetes who have endothelial dysfunction despite optimal statin therapy, aims to investigate whether the addition of Nicotinic Acid Prolonged Release (titrated to a maximum dose of 1500mg orally daily) compared to a control group of no Nicotinic Acid Prolonged Release (Nicotinic Acid PR) improves endothelial dysfunction.

Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 79 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at: A study to investigate the effect of taking Nicotinic Acid Prolonged Release on abnormal artery blood vessel function in people with Type 2 diabetes who are on best-dose treatment with statin medications. It is open to Both males and females, aged 40 to 79. To take part, you generally need: treatment with HMG-CoA reductase inhibitor (statin) at a stable dose for >=6 weeks. There are also some health conditions and factors that may prevent you from joining.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

23 week randomised end-point blinded, controlled parallel study comparing Nicotinic Acid Prolonged Release (PR) orally daily (titrated to a maximum dose of 1500mg) with a No Nicotinic Acid PR group.

23 week randomised end-point blinded, controlled parallel study comparing Nicotinic Acid Prolonged Release (PR) orally daily (titrated to a maximum dose of 1500mg) with a No Nicotinic Acid PR group. Nicotinic Acid PR will commence at 500mg orally daily at bedtime and be titrated at weeks 5 and 9 to 1000mg and 1500mg respectively, according to the subjects maximum tolerated dose. The maximum tolerated dose will not exeed 1500mg orally daily. If a subject is unable to tolerate an increased dose level due to skin flushing episodes, their dose will be decreased back to the preceding dosel level. If a subject is unable to tolerate Nicotinic Acid PR 500mg orally daily, they will be withdrawn for the study.

Locations(1)

Australia

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ACTRN12606000466549