Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine

The study duration per participant is approximatively 18 weeks and 1 day including an up to
2-week screening period, a 16-week treatment period and 1-day post-treatment follow-up
period.

Inclusion criteria:

- Participants with type 1 diabetes mellitus.

- Participants on continuous insulin treatment for at least 12 months prior to
screening.

- Participants on a multiple (≥3) daily injection insulin regimen using NovoLog as
mealtime insulin and insulin glargine (100 U/mL) as basal insulin for at least 3
months prior to screening.

- Glycated hemoglobin (HbA1c) below 10% (85.79 mmol/mol) (inclusive) at screening.

- Body mass index (BMI) ≤35 kg/m² at screening.

Exclusion criteria:

- Pancreatectomy and/or islet cell transplantation.

- Clinically significant laboratory findings, as defined by the protocol.

- Known presence of factors that interfere with the HbA1c measurement.

- History of severe hypoglycemia requiring emergency room admission or hospitalization
within 3 months prior to screening.

- Hospitalization for recurrent diabetic ketoacidosis within 3 months prior to
screening.

- Retinopathy or maculopathy with one of the following treatments, either recent (within
3 months of screening) or planned: intravitreal injections or laser or vitrectomy
surgery.

- Use of glucose lowering treatments other than the multiple dose injections (MDI) and
basal insulin regimen (including use of insulin pump therapy), within 3 months prior
to screening.

- Participants having received systemic glucocorticoids (topical, nasal spray, inhaled
or intra-articular applications are allowed) for one week or more within 3 months
prior to screening.

- Participants having received immunosuppressive agents within 6 months prior to
screening.

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