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)
Condition: Hypercholesterolaemia
MeSH terms: Hypercholesterolemia
Intervention: Alirocumab; Placebo; Lipid-Modifying Therapy (LMT); Antihyperglycemic Drug
Intervention description: Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.; Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.; Statins at stable, maximally tolerated dose with or without other LMT as clinically indicated.; Insulin (injectable or inhaled) alone or with other antihyperglycemic drugs as clinically indicated.
Intervention MeSH terms: Hypoglycemic Agents; Alirocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 517.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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).
    

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.