Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

Exclusion Criteria

• •At screening:
• •Age \< legal age of adulthood.
• •HbA1c\<7% or \>10.5%.
• •Basal insulin treatment has not been at a stable regimen for at least 3 months and at a stable dose (± 20%) of at least 15 U/day for at least 2 months prior to screening visit.
• •If metformin is given, metformin treatment has not been at a stable dose of at least 1.0 g/day for at least 3 months prior to screening visit.
• •History of hypoglycemia unawareness.
• •Body Mass Index (BMI) ≤20 kg/m².
• •Use of other oral or injectable glucose-lowering agents other than basal insulin or metformin within 3 months prior to the time of screening.
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.