Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine

The study will consist of a: up to 2 weeks screening period, 26-week treatment period, and
1-day follow-up period.

The maximum study duration will then be 28 weeks per participant and a 1-day safety
follow-up.

Inclusion criteria:

- Participants with T2DM diagnosed for at least 12 months and treated with insulin
glargine and Humalog®/Liprolog® or NovoLog®/NovoRapid® (at least 3 times daily, before
each meal) in the 6 months prior to the screening visit.

- Signed written informed consent.

Exclusion criteria:

- At screening visit, age under legal age of adulthood.

- HbA1c <6.5% or >10.0% at screening.

- Diabetes other than T2DM.

- Pregnancy and lactation.

- Women of childbearing potential not protected by highly effective contraceptive method
of birth control.

- Use of insulin pump in the 6 months before screening visit.

- Use of insulin other than insulin glargine and Humalog or NovoLog/NovoRapid in the 6
months prior to screening visit. Liprolog® is an European Union (EU) approved insulin
lispro and is allowed in those countries where it is marketed.

- Use of Humalog/Liprolog or Novolog/NovoRapid less than 3 times daily, before each
meal.

- Use of non-injectable peptides (eg, Glucagon-like peptide-1 (GLP-1) receptor-agonists
or other peptides) in the 6 months prior to screening visit.

- Body mass index (BMI) >=40kg/m² at screening visit.

- Hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.

- Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic
retinopathy or macular edema likely to require treatment (eg, laser, surgical
treatment, or injectable drugs) during the study period.

- The above information is not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial