Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin glargine,300 U/mL; Insulin glargine (100 units /mL); Background therapy
Intervention description: Subcutaneous injection in the morning or evening using a prefilled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 milligram/deciliter (mg/dL) (5.0 to 7.2 millimol per liter [mmol/L]); Subcutaneous injection in the morning or evening using a prefilled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L); Fast-acting mealtime insulin analogs
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 463.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in
      terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with
      type 1 diabetes mellitus.

      .

      Secondary Objectives:

      To compare HOE901-U300 and Lantus in terms of:

        -  Percentage of participants reaching target HbA1c and fasting plasma glucose (FPG).

        -  To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events
           of hyperglycemia with ketosis, and development of anti-insulin-antibodies.
    

Eligibility criteria:

        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 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 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.