Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin glargine, 300 U/ml; Insulin degludec, 100U/ml; Background therapy: Rapid acting insulin analogs
Intervention description: Pharmaceutical form: solution for injection in a prefilled pen
Route of administration: SC injection; Pharmaceutical form: solution for injection in a prefilled pen
Route of administration: SC injection; Route of administration: SC injection
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin, Short-Acting
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 343.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate the non-inferiority of insulin glargine 300 units per milliliter (U/ml) in
      comparison to insulin degludec 100 U/ml on glycemic control and variability in participants
      with diabetes mellitus.

      Secondary Objective:

      To evaluate the glycemic control and variability parameters in each treatment group at Week
      12 using Continuous Glucose Monitoring.

      To evaluate the safety of insulin glargine 300 U/ml in comparison to insulin degludec 100
      U/ml.
    

Eligibility criteria:

        Inclusion criteria :

          -  Participants with Type 1 Diabetes mellitus.

          -  Participants treated with multiple daily injections using basal insulin analog once
             daily and rapid acting insulin analogs for at least one year.

          -  HbA1c greater than or equal to (>=) 7 percent (%) (53 millimoles per mole [mmol/mol])
             and less than or equal to (<=) 10% (86 mmol/mol) at screening.

        Exclusion criteria:

          -  Participants not on stable dose of basal insulin analog.

          -  Participants having received Toujeo or Tresiba as basal insulin within 30 days prior
             to screening.

          -  Participants not having used the same insulins (both basal and rapid) within 30 days
             prior to screening.

          -  Participants having received basal insulin dose >= 0.6 units per kilogram body weight
             within 30 days prior to screening.

          -  Participants having received any glucose lowering drugs (including any premixed
             insulins, human regular insulin as mealtime insulins, any others injectable or oral),
             other than basal and rapid insulin analogs, within 3 months prior to screening.

          -  End stage renal disease or on renal replacement treatment.

          -  Retinopathy or maculopathy with one of the following treatments, either recent (within
             3 months prior to screening) or planned: intravitreal injections or laser or
             vitrectomy surgery.

          -  Body weight change >=5 kilogram within 3 months prior to screening.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.