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)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: Alirocumab; Statins; Ezetimibe; Fenofibrate; Nicotinic acid; Omega-3 fatty acids; 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.; Statins at stable dose without other LMT as clinically indicated.; Pharmaceutical form: tablet Route of administration: oral; Pharmaceutical form: tablet Route of administration: oral; Pharmaceutical form: tablet Route of administration: oral; Pharmaceutical form: tablet Route of administration: oral; Insulin (injectable or inhaled) or other antihyperglycemic drugs as clinically indicated.
Intervention MeSH terms: Nicotinic Acids; Niacin; Niacinamide; Hypoglycemic Agents; Ezetimibe; Alirocumab; Fenofibrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 413.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate the superiority of alirocumab in comparison with usual care in the reduction
      of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes
      and mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled
      with maximally tolerated statin therapy.

      Secondary Objectives:

        -  To demonstrate whether alirocumab is superior in comparison with usual care in its
           effects on other lipid parameters (ie, low-density lipoprotein cholesterol (LDL-C),
           apolipoprotein B (Apo B), total cholesterol (Total -C), lipoprotein a (Lp[a]),
           high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), triglyceride rich
           lipoproteins (TGRLs), apolipoprotein A-1 (Apo A-1), apolipoprotein C-III (Apo C-III),
           lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy (ie, LDL-C particle
           size and LDL, very low-density lipoprotein [VLDL], HDL, and intermediate-density
           lipoprotein [IDL] particle number).

        -  To assess changes in glycemic parameters with alirocumab vs. usual care treatment.

        -  To demonstrate the safety and tolerability of alirocumab.

        -  To evaluate treatment acceptance of alirocumab.

        -  To evaluate proprotein convertase subtilisin kexin type 9 (PCSK9) concentrations and
           antibody development.

        -  To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other
           lipid parameters (subgroup analysis).
    

Eligibility criteria:

        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.

        Exclusion criteria:

          -  Use of any lipid modifying therapies other than statins within the last 4 weeks (eg,
             ezetimibe, fenofibrate, nicotinic acid, omega-3 fatty acids, etc.) or use of over the
             counter products/nutraceuticals known to impact lipids (eg, red yeast rice) within the
             last 4 weeks.

          -  Currently drinking more than 2 standard alcoholic drinks per day.

          -  Body Mass Index (BMI) >45 kg/m² or currently enrolled in a weight loss program and
             still in active phase of weight loss.

          -  Glycosylated hemoglobin (HbA1c) 9% or greater.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.