Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)

Inclusion Criteria

• •Participants with type 2 diabetes and mixed dyslipidemia whose non-HDL-C was not adequately controlled with a stable, maximum dose/regimen of statin that was tolerated by the participant.
• •18 years of age or more.
• •Documented history of atherosclerotic cardiovascular disease (ASCVD) or at least one additional cardiovascular risk factor.
• •Non-HDL-C of 100 mg/dL or greater.
• •Triglycerides greater than or equal to 150 mg/dL and less than 500 mg/dL.
• •Stable anti-hyperglycemic agents for at least 3 months prior to the screening visit and between screening and randomization (including stable insulin dose defined as no variation more than 30% in daily insulin dose within the preceding 3 months, as judged by the Investigator).
• •No change in weight of more than 5 kg within the prior 3 months.
• •On stable dose of medications that are known to influence weight and/or lipids within the last 3 months.