Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin Aspart SAR341402; Insulin Aspart; Insulin glargine U100
Intervention description: Pharmaceutical form: Solution for injection Route of administration: Subcutaneous; Pharmaceutical form: Solution for injection Route of administration: Subcutaneous; Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate similarity in pharmacokinetics (PK) of SAR341402 and NovoLog after 4x4-week
      periods of alternating administration of SAR341402 and NovoLog compared to 16-week continuous
      use of NovoLog in participants with Type 1 diabetes mellitus (T1DM) also using insulin
      glargine.

      Secondary Objectives:

        -  To compare the effects of alternating administration of SAR341402 and NovoLog with
           continuous use of NovoLog on immunogenicity.

        -  To evaluate the safety of alternating administration of SAR341402 and NovoLog versus
           continuous use of NovoLog.

        -  To compare other PK parameters between the two treatment arms (alternating
           administration of SAR341402 and NovoLog and continuous use of NovoLog).
    

Eligibility criteria:

        Inclusion criteria:

          -  Participants with T1DM.

          -  Participants on continuous insulin treatment for at least 12 months prior to
             screening.

          -  Participants exclusively on a multiple (greater than or equal to 3) daily injection
             insulin analogue regimen using:

               -  NovoLog as mealtime insulin for at least 12 weeks prior to screening and

               -  Insulin glargine (100 units per milliliter [U/mL]) as basal insulin for at least
                  12 weeks prior to screening. Note: Participants not meeting this criterion could
                  also qualify, provided that they completed the run-in period during which NovoLog
                  and Lantus was administered so that, at the time of randomization, the
                  participants had been on NovoLog and insulin glargine (100 U/mL) for at least 12
                  weeks (including any potential pre-screening administration).

          -  Glycated hemoglobin (HbA1c) less than or equal to 10 percent (%) (85.79 millimoles per
             mole) at screening.

          -  Body mass index less than or equal to 35 kilograms per meter square (kg/m^2) at
             screening.

        Exclusion criteria:

          -  Pancreatectomy and/or islet cell transplantation.

          -  Clinically significant laboratory findings, as defined by the protocol.

          -  Known presence of factors that interfered with the HbA1c measurement.

          -  History of severe hypoglycemia required emergency room admission or hospitalization
             within 3 months prior to screening.

          -  Hospitalization for recurrent diabetic ketoacidosis within 3 months prior to
             screening.

          -  Retinopathy or maculopathy with one of the following treatments, either recent (within
             3 months of screening) or planned: intravitreal injections or laser or vitrectomy
             surgery.

          -  Use of glucose lowering treatments other than the multiple dose injections and basal
             insulin regimen (including use of insulin pump therapy), within 12 weeks prior to
             screening.

          -  Participants had received systemic glucocorticoids for one week or more within 3
             months prior to screening (topical, nasal spray, inhaled or intra-articular
             applications are allowed).

          -  Participants had received systemic immunosuppressive agents within 6 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.