CompletedPhase 2

Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients

United States, Canada, Germany189 participantsStarted 2009-12

Plain-language summary

This study will evaluate the effect of ACZ885 on vascular function in patients with documented atherosclerotic disease and T2DM or IGT.

Who can participate

Age range

18 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with known atherosclerotic disease and documented diagnosis of T2DM for ≤ 14 years OR IGT * HbA1c between 6.0% and 10.0% * On stable statin therapy or statin intolerant * Patients who are eligible and able to participate in the study Exclusion Criteria: * Contraindications to MRI * NYHA class IV Heart Failure * NYHA class I - III heart failure with acute exacerbation in 3 months prior to screening * Patients with type 1 diabetes * Acute infections * HsCRP \> 30 mg/dL * Aortic aneurysm ≥5cm Other protocol-defined inclusion/exclusion criteria may apply

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Adverse Events, Serious Adverse Events and Death

Timeframe: 12 months

Change From Baseline in Aortic Distensibility

Timeframe: baseline, 3 months, 12 months

Change From Baseline in Plaque Burden (Aortic Vessel Wall Area and Carotid Vessel Wall Area)

Timeframe: baseline, 3 months, 12 months

Trial details

NCT IDNCT00995930

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-02

Results submitted2015-01-29

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials

Who can participate

Age range

18 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Adverse Events, Serious Adverse Events and Death

Timeframe: 12 months

Change From Baseline in Aortic Distensibility

Timeframe: baseline, 3 months, 12 months

Change From Baseline in Plaque Burden (Aortic Vessel Wall Area and Carotid Vessel Wall Area)

Timeframe: baseline, 3 months, 12 months