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

Inclusion criteria:

• Participants ≥65 years old with type 2 diabetes mellitus, inadequately controlled onantidiabetic regimens either including no insulin, or with basal insulin as their onlyinsulin.

• Signed informed consent.

Exclusion criteria:

• HbA1c at screening visit:

• <7.0% or >10.0% for participants taking basal insulin.

• <7.5% or >11.0% for insulin-naïve participants.

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

• Participants not on stable basal insulin dose (±10% in the last 8 weeks prior toscreening visit).

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

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

• Cognitive disorder and dementia assessed clinically and by Mini-Mental StateExamination (MMSE) score <24, or any neurologic disorder that would likely affect theparticipant's ability to follow the study procedure. The participant would be eligibledespite an MMSE score <24 if the investigator determined that the low score reflectededucational or cultural background and not dementia as long as the participant wasotherwise able to meet the study requirements.

• Participants who had end-stage renal disease (<15 mL/min/1.73m^2, per estimatedGlomerular filtration rate (eGFR) measurement by Modification of Diet in Renal Disease (MDRD). The above information was not intended to contain all considerations relevant to aparticipant's potential participation in a clinical trial.