Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin

- Up to 4-week screening period;

- 16-week open-label comparative efficacy and safety treatment period;

- 4-week post-treatment safety follow-up period.

Inclusion criteria :

- Patients with type 1 diabetes mellitus

Exclusion criteria:

- HbA1c >9% (at screening);

- Patients receiving >0.5 U/kg body weight basal insulin in the last 30 days prior to
screening visit;

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

- Less than 1 year on any basal plus mealtime insulin;

- Patients using pre-mix insulins, human regular insulin as mealtime insulin and/or any
antidiabetic 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;

- Any contraindication to use of insulin glargine as defined in the national product
label;

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

- Hospitalization for diabetic ketoacidosis or history of severe hypoglycemia
(requiring 3rd party assistance) in the last 6 months prior to randomization;

- Initiation of any glucose-lowering agents in the last 3 months before screening
visit; Weight change of ≥5 kg during the last 3 months prior to screening visit;

- Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic
retinopathy or macular edema likely to require 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.