Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: SAR342434; Humalog; insulin glargine HOE901
Intervention description: SAR342434 100 U/mL (dose range of 1 Unit to 80 Units) self-administered by subcutaneous (SC) injection, immediately (within 5 -10 minutes) before meals intake. Dose adjusted to achieve 2 hour post prandial glucose (PPG) in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycemia.; Humalog 100 U/ml (dose range of 1 unit to 60 units) self-administered by SC injection, immediately (within 5-10 minutes) before meals intake. Dose adjusted to achieve a 2 hour PPG in range of 6.7 to 8.9 mmol/L (120 to 160 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 (SMPG) 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 Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 505.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate non-inferiority of SAR342434 versus Humalog in glycated hemoglobin A1c (HbA1c)
      change from baseline to Week 26 in participants with type 2 diabetes mellitus (T2DM) also
      using insulin glargine.

      Secondary Objectives:

      To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status
      and antibody titers at baseline and during the course of the study; To assess the
      relationship of anti-insulin antibodies with efficacy and safety. To assess the efficacy of
      SAR342434 and Humalog on: proportion of participants reaching target HbA1c <7.0% and <=6.5%,
      fasting plasma glucose (FPG) and self-measured plasma glucose (SMPG) profiles, and insulin
      dose.

      To assess safety of SAR342434 and Humalog.
    

Eligibility criteria:

        Inclusion criteria:

          -  Participants with T2DM diagnosed for at least 12 months and treated with insulin
             glargine and Humalog®/Liprolog® or NovoLog®/NovoRapid® (at least 3 times daily, before
             each meal) in the 6 months prior to the screening visit.

          -  Signed written informed consent.

        Exclusion criteria:

          -  At screening visit, age under legal age of adulthood.

          -  HbA1c <6.5% or >10.0% at screening.

          -  Diabetes other than T2DM.

          -  Pregnancy and lactation.

          -  Women of childbearing potential not protected by highly effective contraceptive method
             of birth control.

          -  Use of insulin pump in the 6 months before screening visit.

          -  Use of insulin other than insulin glargine and Humalog or NovoLog/NovoRapid in the 6
             months prior to screening visit. Liprolog® is an European Union (EU) approved insulin
             lispro and is allowed in those countries where it is marketed.

          -  Use of Humalog/Liprolog or Novolog/NovoRapid less than 3 times daily, before each
             meal.

          -  Use of non-injectable peptides (eg, Glucagon-like peptide-1 (GLP-1) receptor-agonists
             or other peptides) in the 6 months prior to screening visit.

          -  Body mass index (BMI) >=40kg/m² at screening visit.

          -  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 (eg, 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