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.

Phase 4

Completed

• Conditions: Subjects with Type 2 diabetes mellitus who are receiving optimal dose statin therapy.; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12606000466549
• Lead Sponsor: Professor Gerald Watts

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Type 2 diabetes; treatment with HMG-CoA reductase inhibitor (statin) at a stable dose for >=6 weeks; treatment with aspirin therapy (100mg orally daily) for >=2 weeks at screening brachial artery ultrasound; fasting LDL-cholesterol <2.5mmol/L; HDL-cholesterol <=1.5mmol/L, brachial artery FMD <=5.50% on screening ultrasound.

Exclusion Criteria

At screening: daytime insulin treatment (nocte insulin permitted); uncontrolled hyperglycaemia (HbA1c level >8.5%); uncontrolled hypertension (resting BP >150/90mmHg); total fasting cholesterol >=6.0mmol/L or triglycerides >=4.5mmol/L; hypersensitivity to nicotinic acid; hypersensitivity to aspirin therapy; treatment with other lipid-regulating medications (eg. fibrate, ezetimibe, cholestyramine, niacin, fish oil) or with CoQ supplements (within previous 6 weeks); current treatment with warfarin, nitrate or PDE5-inhibitor (eg. sildenafil); history peptic ulcer disease; history of arterial bleeding; recent cardiovascular event (within previous 6 months); atrial fibrillation or other significant dysrhythmia; significantly abnormal renal (creatinine >150ummol/L), liver (ALT >3 times ULN) or thyroid function; Significantly abnormal creatine kinase >3 times ULN; significant anaemia; history of gout; current smoker (previous 6 months); ethanol intake>21 standard drinks/week; significant substance abuse, psychiatric illness or likely poor compliance with study protocol; any other serious illness (eg. cancer) or likelihood of not completing study; technical difficulty with obtaining ultrasound scan of sufficient quality; weight>150kg.

Study & Design

• Study Type: Interventional
• Study Design: Not specified