EDITION JP IA 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period

Date de début de l'étude : 1 septembre 2012

Inclusion criteria: Patients with type 1 diabetes mellitus Exclusion criteria: Age < 18 years at screening visit; HbA1c < 7.0 % or > 10.0 % (national glycohemoglobin standardization program [NGSP] value) at screening visit; Patients less than 1 year before screening visit on any basal plus mealtime insulin; 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 rapid-insulin analogue in the last 3 months before screening visit; Use of an insulin pump in the last 6 months before screening visit and/or plan to switch to insulin pump in next 12 months; 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 (eq, 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.