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

The study duration per patient will be approximately 58 weeks that consists of a 2 week
screening period, a 6-month comparative efficacy and safety treatment period, a 6-month
comparative safety extension period, and a 4-week post treatment follow up period.

Inclusion criteria :

- Children and adolescents with type 1 diabetes mellitus (T1DM) for at least 1 year
confirmed by typical symptoms at diagnosis and/or by antibody testing (presence of
anti-GAD (glutamic acid decarboxylase) or anti-IA2 (islet antigen 2/tyrosine
phosphatase) or anti-islet cell antibodies) and/or clinical features (eg, history of
ketoacidosis).

- Signed written informed consent obtained from parent(s)/legal guardian and written or
oral assent obtained from patient.

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.

- Patients using premix insulins in the last 3 months before screening visit or patients
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.

- 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 are unwilling or unable to be tested for pregnancy. Abstinence from sexual
intercourse will be considered as an acceptable form of birth control.

- Pregnant or breast-feeding adolescents, or adolescents who intend to become pregnant
during the study period, or who are 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 patient's
potential participation in a clinical trial.