Last updated on November 2017

A Study to Evaluate the Efficacy and Safety of Alirocumab versus Usual Care in Patients with Type 2 Diabetes and Mixed Dyslipidemia at High Cardiovascular Risk Not Adequately Controlled with Maximally Tolerated Statin Therapy


Brief description of study

A Study to Evaluate the Efficacy and Safety of Alirocumab versus Usual Care in Patients with Type 2 Diabetes and Mixed Dyslipidemia at High Cardiovascular Risk Not Adequately Controlled with Maximally Tolerated Statin Therapy

Detailed Study Description

You are being asked to participate in a study of a new drug, Alirocumab [“study drug”] because you have high cholesterol despite the cholesterol lowering drugs you are currently taking. The study drug is a fully human monoclonal antibody (a type of protein). The study drug is a type of antibody made in a lab to be like the ones made naturally by your body. The study drug is approved by the FDA but not for use in lowering LDL cholesterol in type 2 diabetes. Its use in this study is considered investigational.

The purpose of this study is to determine whether the study drug, given to you by subcutaneous injection (injection under the skin), for a duration of 6 months, is safe and effective in lowering your blood cholesterol level (more specifically your non-HDL-C cholesterol) compared with your study doctor’s usual care, when added to the cholesterol lowering medication you are presently taking (statins) and the diet you are following.

Clinical Study Identifier: TX7946

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Columbus Regional Research Institute

Columbus Regional Research Institute
Columbus, GA USA
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