Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus

- Up to 2-week screening period;

- 6-month open-label comparative efficacy and safety treatment period;

- 6-month open-label comparative safety extension period;

- 48-hour post-treatment safety follow-up period

Inclusion criteria :

- Adult Patients with type 1 diabetes mellitus

Exclusion criteria:

- HbA1c <7.0% (53 mmol/mol) or >10% (86 mmol/mol) at screening;

- Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood
glucose before screening visit;

- Patients not on stable insulin dose (±20% total basal insulin dose) in the last 30
days prior to screening visit;

- Patients using pre-mix insulins, human regular insulin as mealtime insulin and/or any
glucose-lowering drugs other than basal insulin and mealtime analogue insulin in the
last 3 months before screening visit;

- Use of an insulin pump in the last 6 months before screening visit and no plan to
switch to insulin pump in the next 12 months;

- Not willing to inject insulin glargine as assigned by the randomization process once
daily in the morning or evening;

- Severe hypoglycemia resulting in coma/seizures, and/or 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
patient's potential participation in a clinical trial.