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)

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.

For the purpose of scientific communication, a first-step analysis (both efficacy and safety)
was performed at the Week 24 cut-off date. A second-step analysis was performed once all
participants had completed the study to include a final update of the safety analysis.

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.