Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: HOE901-U300 (Insulin glargine new formulation); Lantus (Insulin glargine)
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: 549.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

        -  To compare the efficacy of a new formulation of insulin glargine and Lantus (overall,
           regardless the injection time) in terms of change of HbA1c from baseline to endpoint
           (scheduled Month 6) in participants with type 1 diabetes mellitus

      Secondary Objective:

        -  To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms
           of:

        -  Change of HbA1c from baseline to endpoint (scheduled Month 6)

        -  Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma
           glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma
           glucose (8-point profiles), glucose variability, treatment satisfaction and health
           related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)

        -  Reaching target HbA1c values and controlled plasma glucose (all and reaching target
           without hypoglycemia)

        -  Frequency of occurrence and diurnal distribution of hypoglycemia by category of
           hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)

        -  Safety and tolerability of HOE901-U300 including development of anti-insulin antibody
           (AIAs) during the 12-month study period
    

Eligibility criteria:

        Inclusion criteria:

          -  Adult participants with type 1 diabetes mellitus

        Exclusion criteria:

          -  HbA1c less than (<) 7.0% (53 mmol/mol) or greater than (>) 10% (86 mmol/mol) at
             screening

          -  Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood
             glucose before screening visit

          -  Participants not on stable insulin dose (+/-20 percent total basal insulin dose) in
             the last 30 days prior to screening visit

          -  Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or
             any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in
             the last 3 months before screening visit

          -  Use of an insulin pump in the last 6 months before screening visit and no plan to
             switch to insulin pump in the next 12 months

          -  Not willing to inject insulin glargine as assigned by the randomization process once
             daily in the morning or evening;

          -  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 (example laser, surgical
             treatment or injectable drugs) 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.