Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine
Condition: Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Intervention: Insulin aspart; NovoLog/NovoRapid; Insulin glargine (HOE901)
Intervention description: SAR341402 100 units per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour postprandial plasma glucose (PPG <10 millimoles/liter [mmol/L] [<180 milligram/deciliter {mg/dL}]) while avoiding hypoglycemia.; NovoLog/NovoRapid 100 U/mL (dose range of 1 unit to 60 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour postprandial plasma glucose (PPG <10 mmol/L [<180 mg/dL]) while avoiding hypoglycemia.; Insulin glargine 100 U/mL injected QD subcutaneously consistent with the local label. Doses adjusted to achieve glycemic target for fasting, preprandial plasma glucose between 4.4 to 7.2 mmol/L (80 to 130 mg/dL) without hypoglycemia.
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: 597.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin
      A1c (HbA1c) change from baseline to Week 26 in participants with type 1 or type 2 diabetes
      mellitus (T1DM or T2DM) also using Lantus®.

      Secondary Objectives:

        -  To assess the immunogenicity of SAR341402 and NovoLog/NovoRapid in terms of
           positive/negative status and anti-insulin antibody (AIA) titers during the course of the
           study.

        -  To assess the relationship of AIAs with efficacy and safety.

        -  To assess the efficacy of SAR341402 and NovoLog/NovoRapid in terms of proportion of
           participants reaching HbA1c lesser than (<) 7.0% and change in HbA1c, fasting plasma
           glucose (FPG), and self-measured plasma glucose (SMPG) profiles from baseline to Week 26
           and Week 52 (only Week 52 for HbA1c).

        -  To assess safety of SAR341402 and NovoLog/NovoRapid.
    

Eligibility criteria:

        Inclusion criteria :

          -  Participants with T1DM or T2DM (T2DM US only) diagnosed for at least 12 months, who
             have been treated with a multiple daily injection regimen with

          -  NovoLog/NovoRapid or insulin lispro (100 U/mL) in the last 6 months prior to screening
             visit AND

          -  insulin glargine (100 U/mL) in the last 6 months prior to screening visit OR insulin
             detemir (Levemir®) in the last 12 months prior to screening visit.

        Exclusion criteria:

          -  At screening visit, age under legal age of adulthood.

          -  HbA1c <7.0% or greater than (>) 10% at screening.

          -  Less than 1 year on continuous insulin treatment.

          -  Use of insulin pump in the last 3 months before screening visit.

          -  Participants with incomplete baseline 7-point SMPG profile, defined as participants
             who do not have 7-point profiles with at least 5 points on at least 2 days in the week
             before randomization Visit 3.

          -  Participants with T1DM: Use of glucose lowering agents other than insulin including
             use of non-insulin injectable peptides in the last 3 months prior to screening.

          -  Participants with T2DM:

               -  Use of glucagon-like peptide-1 (GLP-1) receptor agonists in the last 3 months
                  before screening visit.

               -  Use of oral antidiabetic drugs (OADs) not on stable dose in the last 3 months
                  before screening visit (sulfonylureas was discontinued at baseline).

          -  At screening visit, body mass index (BMI) greater than or equal to (>=) 35 kilogram
             per meter square (kg/m^2) in participants with T1DM and >=40 kg/m^2 in participants
             with T2DM.

          -  Use of insulin other than:

               -  insulin glargine 100 U/mL and NovoLog/NovoRapid or insulin lispro 100 U/mL as
                  part of a multiple injection regimen in the last 6 months before screening visit,
                  OR

               -  insulin detemir 100 U/mL in the 12 months before screening visit and
                  NovoLog/NovoRapid or insulin lispro 100 U/mL in the last 6 months before
                  screening visit as part of a multiple injection regimen.

          -  Status post pancreatectomy.

          -  Status post pancreas and/or islet cell transplantation.

          -  Hospitalization for recurrent diabetic ketoacidosis in the last 3 months before
             screening visit.

          -  History of severe hypoglycemia requiring Emergency Room admission or hospitalization
             in the last 3 months before screening visit.

          -  Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic
             retinopathy or macular edema likely to require treatment (eg, laser, surgical
             treatment or injectable drugs) during the study period.

          -  Pregnant or breastfeeding women.

          -  Women of childbearing potential not protected by highly effective method(s) of birth
             control.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.