Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy

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

- up to 2 week screening period; it can be exceptionally extended of up to one additional
week;

- 6-month comparative efficacy and safety treatment period;

- 6-month comparative safety extension period;

- 2-day post-treatment safety follow-up period.

Inclusion criteria :

- Adult patients with type 2 diabetes mellitus inadequately controlled with non-insulin
antihyperglycemic drug(s);

- Signed written informed consent.

Exclusion criteria:

- HbA1c < 7.0% (< 53 mmol/mol) or > 11% (> 97 mmol/mol) [at screening];

- History of type 2 diabetes mellitus for less than 1 year before screening;

- Less than 6 months before screening with non-insulin antihyperglycemic treatment;

- Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before
screening;

- Initiation of new glucose-lowering medications and/or weight loss drug in the last 3
months before screening visit and/or initiation of GLP-1 receptor agonist in the last
6 months before screening visit;

- Patients receiving only non-insulin antihyperglycemic drugs not approved for
combination with insulin according to local labeling/local treatment guidelines
and/or sulfonylurea or glinide (Note: non-insulin antihyperglycemic drugs not
approved for combination with insulin, sulfonylurea and glinide are to be
discontinued at baseline);

- Current or previous insulin use except for a maximum of 8 consecutive days (e.g.
acute illness, surgery) during the last year prior to screening;

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