Comparison of SAR342434 to Humalog as the Rapid Acting Insulin 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: SAR342434; Humalog; Insulin glargine HOE901
Intervention description: SAR342434 100 U/mL (dose range of 1 Unit to 80 Units) self-administered by deep subcutaneous (SC) injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour post prandial plasma 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 deep SC injection, immediately (within 5-10 minutes) before meal 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 hypoglycaemia.; 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: 507.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate non-inferiority of SAR342434 versus Humalog in glycated haemoglobin A1c
      (HbA1c) change from baseline to Week 26 in participants with type 1 diabetes mellitus (T1DM)
      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 including
      during the safety extension.

      To assess the efficacy of SAR342434 and Humalog in terms of proportion of participants
      reaching target HbA1c (<7%), Fasting plasma glucose (FPG), self-measured plasma glucose
      (SMPG) profiles, and insulin dose.

      To assess safety of SAR342434 and Humalog.
    

Eligibility criteria:

        Inclusion criteria:

          -  Participants with T1DM diagnosed for at least 12 months and had been treated with
             insulin glargine and Humalog or Novolog®/Novo Rapid® (at least 3 times daily before
             each meal) in the 6 months prior to the screening visit.

          -  Written informed consent.

        Exclusion criteria:

          -  At screening visit, age under legal age of adulthood.

          -  HbA1c <7.0% or >10% at screening.

          -  Diabetes other than T1DM.

          -  Status post pancreatectomy.

          -  Status post pancreas and/or islet cell transplantation.

          -  Pregnancy and lactation.

          -  Women of childbearing potential not protected by highly effective contraceptive method
             of birth control.

          -  Less than 1 year on continuous insulin treatment.

          -  Use of insulin pump in the last 6 months before screening visit.

          -  Use of glucose lowering treatments other than insulin including non-insulin injectable
             peptides in the last 6 months prior to screening visit.

          -  Use of insulin other than insulin glargine and Humalog or Novolog/Novo Rapid as part
             of a multiple injection regimen (3 to 4 injections per day) in the last 6 months
             before screening visit. Liprolog® is a European Union approved insulin lispro and is
             allowed in those countries where it is marketed.

          -  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.