Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus (EDITION IV)

Inclusion criteria :

• Adult Patients with type 1 diabetes mellitus

Exclusion criteria:

• HbA1c <7.0% (53 mmol/mol) or >10% (86 mmol/mol) at screening;
• Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit;
• Patients not on stable insulin dose (±20% total basal insulin dose) in the last 30 days prior to screening visit;
• Patients using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit;
• Use of an insulin pump in the last 6 months before screening visit and no plan to switch to insulin pump in the next 12 months;
• Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening;
• 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.