A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus 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 300 U/ml); Lantus (Insulin Glargine 100 U/ml); Mandated back ground therapy
Intervention description: Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast) using a pre-filled pen.; Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast using a pre-filled pen.; Rapid insulin analogs: e.g., insulin glulisine, insulin lispro or insulin aspart, used by participant at least 30 days before screening. Mealtime insulin was to be continued during the study and titrated towards protocol specified postprandial glucose targets (130-180 mg/dL).
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 638.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate that morning injection of Toujeo (HOE901-U300) compared to Lantus provides
      better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult
      participants with type 1 diabetes mellitus.

      Secondary Objective:

      To demonstrate that treatment with HOE901-U300 compared to Lantus provides:

        -  Lower incidence rate of nocturnal symptomatic hypoglycemia;

        -  Better glucose control coverage during the last hours of CGM before next basal-insulin
           dosing;

        -  Less variability in CGM profile.
    

Eligibility criteria:

        Inclusion criteria:

          -  Adult participants (male and female) with type 1 diabetes mellitus (T1DM).

          -  Signed written informed consent.

        Exclusion criteria:

          -  Age <18 years or >70 years.

          -  Fasting c-peptide ≥0.3 nmol/L as per source document or central lab test at Visit 1.

          -  Glycated hemoglobin (HbA1c) ≤ 6.5 % or ≥ 10.0% via central lab test at Visit 1.

          -  Participants who experienced none of episode of documented symptomatic and/or severe
             hypoglycemia (as per the American Diabetes Association (ADA) classification) during
             the past month prior to screening.

          -  Participants who experienced >1 episode of severe hypoglycemia resulting in
             coma/seizures during the last 12 months before screening.

          -  Participants received less than 1 year treatment with basal plus mealtime insulin.

          -  Used any basal insulins other than long-acting insulin analogs (ie, Lantus, Toujeo,
             Levemir, and Tresiba) in the past 3 months before screening.

          -  Required >80 U/day basal insulin analogs or not on stable dose (±20% total dose)
             within 30 days prior to screening.

          -  Used fewer than 2 injections of rapid-acting insulin analog per day within 30 days
             prior to screening.

          -  Used human regular insulin as mealtime insulin within 30 days prior to screening.

          -  Used an insulin pump during the last 6 months before screening.

          -  History of unstable proliferative diabetic retinopathy or any other rapidly
             progressive diabetic retinopathy or macular edema likely to required treatment (e.g.,
             laser, surgical treatment, or injectable drugs) during the study period.

          -  Pregnant or breast-feeding women or planned pregnancy during the duration of the
             study.

          -  Use of any other investigational drug(s) within 1 month or 5 half-lives, whichever was
             longer prior to screening.

          -  Inappropriate CGM use during screening period evidenced by failure to obtain a minimum
             of 4 days of usable records by the end of screening.

          -  Noncompliance with self-monitored plasma glucose (SMPG) performance evidenced by
             failure to demonstrate at least 5 days of 5 point SMPG records by the end of
             screening.

        The above information is not intended to contain all considerations relevant to a
        participants's potential participation in a clinical trial.