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)
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)
Primary Objectives:

 -  To demonstrate the superiority of alirocumab in comparison with placebo in the reduction
 of calculated low-density lipoprotein cholesterol (LDL-C) in participants with diabetes
 treated with insulin and with hypercholesterolemia at high cardiovascular risk not
 adequately controlled on maximally tolerated LDL-C lowering therapy.

 -  To evaluate the safety and tolerability of alirocumab in participants with diabetes
 treated with insulin.

 Secondary Objective:

 To demonstrate that alirocumab was superior in comparison to placebo in its effects on other
 lipid parameters (i.e., measured LDL-C, non-high-density lipoprotein cholesterol [non-HDL-C],
 apolipoprotein B [Apo B], total cholesterol [TC], lipoprotein a [Lp(a)], high density
 lipoprotein cholesterol [HDL-C], triglyceride [TG] levels, triglyceride rich lipoproteins
 [TGRL], apolipoprotein A-1 [Apo A-1], apolipoprotein C-III [Apo C-III], and LDL particle
 number and size).
The maximum study duration was approximately 9 months per participant, including a 6 month
 treatment period, a screening period of up to 3 weeks, and an 8 week safety observation
 period.
Inclusion criteria:

 -  Participants diagnosed with Type 1 or Type 2 diabetes at least one year prior to the
 screening visit (Week -3).

 -  Signed written informed consent

 -  Participants with type 1 or type 2 diabetes treated with insulin whose LDL-C levels
 were not adequately controlled with maximally tolerated lipid-modifying therapy

 -  LDL-C of 70 mg/dL or greater

 -  18 years of age or more

 -  Glycosylated hemoglobin (HbA1c) less than 10%

 -  History of cardiovascular disease (including coronary heart disease [CHD] and/or CHD
 risk equivalents) and/or at least one additional cardiovascular risk factor

 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.