Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications

The study consists of a 4-week screening period, a 26-week treatment period comparing
HOE901-U300 to Lantus, and a 2-day safety follow-up period.

Inclusion criteria:

- Patients ≥65 years old with type 2 diabetes mellitus, inadequately controlled on
antidiabetic regimens either including no insulin, or with basal insulin as their
only insulin.

- Signed informed consent.

Exclusion criteria:

- HbA1c at screening visit:

- <7.0% or >10.0% for patients taking basal insulin.

- <7.5% or >11.0% for insulin-naïve patients.

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

- Patients not on stable basal insulin dose (±10% in the last 8 weeks prior to
screening visit).

- Change in dose of antidiabetic treatment or initiation of new glucose-lowering
medications in the last 8 weeks prior to screening.

- Chronic (>10 days continuous use in previous 6 months) use of bolus insulin
injections, whether given separately or as part of a combination with basal insulin,
eg, premix insulin; For insulin-naïve individuals: current or previous insulin use
except for a maximum of 10 consecutive days (e.g. acute illness, surgery) during the
last year prior to screening.

- Cognitive disorder and dementia assessed clinically and by Mini-Mental State
Examination (MMSE) score <24, or any neurologic disorder that will likely affect the
patient's ability to follow the study procedure. The patient will be eligible despite
an MMSE score <24 if the investigator determines that the low score reflects
educational or cultural background and not dementia as long as the patient is
otherwise able to meet the study requirements.

- Patients who have end-stage renal disease (<15 mL/min/1.73m^2, per estimated
Glomerular filtration rate [eGFR] measurement by Modification of Diet in Renal
Disease [MDRD]).

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.