Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine

The study will consist of a 2-week screening period, a 26-week treatment period, a 26-week
comparative safety extension period, and a 1-day follow-up period. The maximum study duration
will then be 54 weeks per patient and a 1 day safety follow-up.

Inclusion criteria :

- Patients with T1DM or T2DM (T2DM US only) diagnosed for at least 12 months, who have
been treated with a multiple daily injection regimen with

- NovoLog/NovoRapid OR insulin lispro (100 U/mL) in the last 6 months prior to screening
visit AND

- insulin glargine (100 U/mL) in the last 6 months prior to screening visit OR insulin
detemir (Levemir®) in the last 12 months prior to screening visit.

Exclusion criteria:

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

- Glycated hemoglobin (HbA1c) <7.0% or >10% at screening.

- Less than 1 year on continuous insulin treatment.

- Use of insulin pump in the last 3 months before screening visit.

- Patients with incomplete baseline 7-point SMPG profile, defined as patients who do not
have 7-point profiles with at least 5 points on at least 2 days in the week before
randomization Visit 3.

- Patients with T1DM: Use of glucose lowering agents other than insulin including use of
non-insulin injectable peptides in the last 3 months prior to screening.

- Patients with T2DM:

- Use of glucagon-like peptide-1 (GLP-1) receptor agonists in the last 3 months
before screening visit.

- Use of oral antidiabetic drugs (OADs) not on stable dose in the last 3 months
before screening visit (sulfonylureas will be discontinued at baseline).

- At screening visit, body mass index (BMI) ≥35 kg/m2 in patients with T1DM and ≥40
kg/m2 in patients with T2DM.

- Use of insulin other than:

- insulin glargine 100 U/mL and NovoLog/NovoRapid or insulin lispro 100 U/mL as
part of a multiple injection regimen in the last 6 months before screening visit,
OR

- insulin detemir 100 U/mL in the 12 months before screening visit and
NovoLog/NovoRapid or insulin lispro 100 U/mL in the last 6 months before
screening visit as part of a multiple injection regimen.

- Status post pancreatectomy.

- Status post pancreas and/or islet cell transplantation.

- Hospitalization for recurrent diabetic ketoacidosis in the last 3 months before
screening visit.

- History of severe hypoglycemia requiring Emergency Room admission or hospitalization
in the last 3 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.

- Pregnant or breastfeeding women.

- Women of childbearing potential not protected by highly effective method(s) of birth
control.

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