Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus

Exclusion Criteria

• •Age \<6 years and \>=18 years at randomization.
• •Less than 1 year on insulin treatment prior to screening visit.
• •Less than 6 months on basal plus mealtime insulin and self-monitoring of blood glucose prior to screening visit.
• •Participants using premix insulins in the last 3 months before screening visit or participants using human regular insulin as mealtime insulin in the last 3 months before screening visit.
• •Use of an insulin pump in the last 6 months before screening visit or plans to switch to pump within the next 6 months after screening visit.
• •Any contraindication to use of insulin glargine as defined in the national product label.
• •No willingness to inject insulin glargine (Lantus or HOE901-U300) once daily.
• •HbA1c \<7.5% or \>11% at screening.
• •Initiation of any glucose-lowering medications in the last 3 months before screening visit.
• •Hospitalization or care in the emergency ward for diabetic ketoacidosis or history of severe hypoglycemia (as defined by need for glucagon or IV glucose) and accompanied by seizure and/or unconsciousness and/or coma in the last 3 months prior to screening visit.
• •Postmenarchal girls not protected by highly-effective method(s) of birth control and/or who were unwilling or unable to be tested for pregnancy. Abstinence from sexual intercourse was considered as an acceptable form of birth control.
• •Pregnant or breast-feeding adolescents, or adolescents who intended to become pregnant during the study period, or who were at risk of getting pregnant due to any psychosocial reason during the study period.
• •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.