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)

Conditions: Hypercholesterolaemia

Summary: 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.

Eligibility criteria:
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.