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

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    Not Recruiting
Updated on 21 April 2022

Summary

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

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.

Details
Condition Diabetes Mellitus, Type 2
Clinical Study IdentifierTX143592
Last Modified on21 April 2022

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