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

Inclusion criteria :

• Children and adolescents with type 1 diabetes mellitus (T1DM) for at least 1 yearconfirmed by typical symptoms at diagnosis and/or by antibody testing [presence ofanti-GAD (glutamic acid decarboxylase) or anti-IA2 (islet antigen 2/tyrosinephosphatase) or anti-islet cell antibodies] and/or clinical features (eg, history ofketoacidosis)].
• Signed written informed consent obtained from parent(s)/legal guardian and written ororal assent obtained from participant.

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 glucoseprior to screening visit.
• Participants using premix insulins in the last 3 months before screening visit orparticipants using human regular insulin as mealtime insulin in the last 3 monthsbefore screening visit.
• Use of an insulin pump in the last 6 months before screening visit or plans to switchto pump within the next 6 months after screening visit.
• Any contraindication to use of insulin glargine as defined in the national productlabel.
• 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 screeningvisit.
• Hospitalization or care in the emergency ward for diabetic ketoacidosis or history ofsevere hypoglycemia (as defined by need for glucagon or IV glucose) and accompanied byseizure and/or unconsciousness and/or coma in the last 3 months prior to screeningvisit.
• Postmenarchal girls not protected by highly-effective method(s) of birth controland/or who were unwilling or unable to be tested for pregnancy. Abstinence from sexualintercourse was considered as an acceptable form of birth control.
• Pregnant or breast-feeding adolescents, or adolescents who intended to become pregnantduring the study period, or who were at risk of getting pregnant due to anypsychosocial reason during the study period. The above information is not intended to contain all considerations relevant to aparticipant's potential participation in a clinical trial.