Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients

The study duration for each patient will be approximately 10 weeks, including a 2-week
screening period, 2 treatment periods of 4 weeks each, and 1-day post-treatment safety
follow-up period.

Inclusion criteria:

- Male and female patients with Type 1 diabetes mellitus (T1DM).

- Age greater than or equal to 18 at the screening visit.

- Diabetes diagnosed at least 12 months before screening visit.

- At least 1 year of insulin treatment with at least 6 months of CSII (Continuous
Subcutaneous Insulin Infusion) treatment with an external insulin pump.

- Demonstration of successful use of insulin pump and performing of a minimum of 4 blood
glucose checks per day during screening.

- Laboratory parameters within the normal range (or defined screening threshold for the
Investigator site), unless the Investigator considers an abnormality to be clinically
irrelevant for T1DM patients.

- Signed written informed consent.

Exclusion criteria:

- Hemoglobin A1c (HbA1c) ≥8.5% at screening.

- Diabetes other than T1DM.

- History of infection at the infusion site within 3 months prior to the screening visit
(Visit 1).

- Use of oral glucose-lowering agents or any injectable glucose-lowering agents other
than insulin during the 3 months before screening visit.

- Hospitalization for recurrent diabetic ketoacidosis (DKA) in the last 6 months before
screening visit.

- History of severe hypoglycemia requiring emergency room admission or hospitalization
in the last 6 months before screening visit.

- Hypoglycemic unawareness as judged by the Investigator in the last 6 months before the
screening visit.

- Any clinically significant abnormality identified on physical examination, laboratory
tests, or vital signs at the time of screening that in the judgment of the
investigator or any sub investigator would preclude safe completion of the study.

- Known history of illegal drug or alcohol abuse within 6 months prior to the time of
screening.

- Use of investigational drug(s) within 3 months or 5 half-lives, whichever is longer,
prior to the screening visit.

- Patients who had previously received SAR341402 in any other clinical trial.

- Any contraindication to the use of NovoLog® as defined in the national product labels;
history of hypersensitivity to NovoLog® or to any of the excipients.

- Pregnancy and lactation.

- If female, pregnancy [defined as positive β-HCG (Human Chorionic Gonadotropin) in
blood or in urine], breast-feeding.

- Patient is an employee or relative of an employee of the sponsor.

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