Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine

The study consisted of a:

- Up to 2 weeks screening period

- 26-week treatment period

- 26-week comparative safety extension period

- 1-day follow-up period

- The maximum study duration would be 54 weeks per participant and a 1-day safety
follow-up

Inclusion criteria:

- Participants with T1DM diagnosed for at least 12 months and had been treated with
insulin glargine and Humalog or Novolog®/Novo Rapid® (at least 3 times daily before
each meal) in the 6 months prior to the screening visit.

- Written informed consent.

Exclusion criteria:

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

- HbA1c <7.0% or >10% at screening.

- Diabetes other than T1DM.

- Status post pancreatectomy.

- Status post pancreas and/or islet cell transplantation.

- Pregnancy and lactation.

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

- Less than 1 year on continuous insulin treatment.

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

- Use of glucose lowering treatments other than insulin including non-insulin injectable
peptides in the last 6 months prior to screening visit.

- Use of insulin other than insulin glargine and Humalog or Novolog/Novo Rapid as part
of a multiple injection regimen (3 to 4 injections per day) in the last 6 months
before screening visit. Liprolog® is a European Union approved insulin lispro and is
allowed in those countries where it is marketed.

- 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.