Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)

Exclusion Criteria

• •Not on a stable dose of statin or other lipid modifying therapy for at least 4 weeks prior to screening or from screening to randomization, unless statin intolerant
• •Triglycerides \>400 mg/dL
• •Estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m² according to the Modification of Diet in Renal Disease (MDRD) equation
• •Currently received or planned to receive renal replacement therapy (for example, hemodialysis)
• •Change in weight of more than 5 kilograms within the prior 2 months
• •Not on a stable dose/regimen of insulin or other antidiabetic drugs for the past 3 months or planned to intensify insulin regimen during the study
• •Not treated with insulin for at least 6 months
• •Planned to start new lipid modifying therapy or change dose of current lipid modifying therapy during the study
• •Body mass index (BMI) \>45 kg/m² or planned to undergo bariatric surgery, weight loss program, or initiate weight loss drugs during the study
• •History of recent decompensation of diabetes within the prior 2 months (for example, diabetic ketoacidosis)
• •The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.