Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy

The maximum study duration will be 54 weeks per patient, consisting of:

- up to 2 week screening period;

- 6-month comparative efficacy and safety treatment period;

- 6-month comparative safety extension period;

- 2-day safety follow-up period.

Inclusion criteria :

o Patients with type 2 diabetes mellitus

Exclusion criteria:

- Age <18 years;

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

- Diabetes other than type 2 diabetes mellitus;

- Less than 6 months on basal insulin treatment together with oral antihyperglycemic
drugs and self-monitoring of blood glucose;

- Patients using sulfonylurea in the last 2 months before screening visit;

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

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

- Initiation of new glucose-lowering medications in the last 3 months before screening
visit;

- History or presence of significant diabetic retinopathy or macular edema likely to
require laser or injectable drugs or surgical treatment during the study period;

- Pregnant or breast-feeding women or women who intend to become pregnant 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.