Comparison of a New Formulation of Insulin Glargine With Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 Diabetes Mellitus

Exclusion Criteria

• •Age \< 18 years at screening visit;
• •BMI(body mass index) ≥ 35 kg/m2 at screening visit;
• •HbA1c \< 7.0% or \> 10% (national glycohemoglobin standardization program \[NGSP\] value) at screening visit;
• •Diabetes other than type 2 diabetes mellitus;
• •Patients on self-monitoring of blood glucose less than 6 months before screening visit;
• •Patients using pre-mix insulins, insulin detemir at 2 times or more a day, or GLP 1 receptor agonists in the last 3 months before screening visit;
• •Patients using mealtime insulin (rapid-acting insulin analogue and short-acting insulin) for more than 10 days in the last 3 months before screening visit;
• •Use of insulin pump in the last 6 months before screening visit;
• •Initiation of new glucose-lowering medications and/or weight loss drugs in the last 3 months before screening visit;
• •Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit;
• •Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, 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.