Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Glargine (HOE901 - U300); Insulin Glargine (HOE901 - U100); Background therapy
Intervention description: Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).; Self-administered by SC injection in the evening using a pre-filled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).; Non-insulin anti-diabetic drugs with the exception of thiazolidinediones.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1014.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin
      A1c (HbA1c).

      Secondary Objectives:

      To demonstrate the superiority of H0E901-U300 in comparison with Lantus in:

        -  Percentage of participants with at least one severe and/or confirmed (by plasma glucose
           ≤70mg/dL [3.9mmol/L]) hypoglycemia event from 22:00 to 08:59 next morning

        -  Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or
           confirmed (≤70mg/dL [3.9mmol/L]) hypoglycemia event

        -  Percentage of participants with at least one severe and/or confirmed (by plasma glucose
           ≤70mg/dL [3.9mmol/L]) hypoglycemia event occurring at any time of day

        -  HbA1c change
    

Eligibility criteria:

        Inclusion criteria:

          -  Participants ≥65 years old with type 2 diabetes mellitus, inadequately controlled on
             antidiabetic regimens either including no insulin, or with basal insulin as their only
             insulin.

          -  Signed informed consent.

        Exclusion criteria:

          -  HbA1c at screening visit:

               -  <7.0% or >10.0% for participants taking basal insulin.

               -  <7.5% or >11.0% for insulin-naïve participants.

          -  History of type 2 diabetes mellitus for less than 1 year before screening.

          -  Participants not on stable basal insulin dose (±10% in the last 8 weeks prior to
             screening visit).

          -  Change in dose of antidiabetic treatment or initiation of new glucose-lowering
             medications in the last 8 weeks prior to screening.

          -  Chronic (>10 days continuous use in previous 6 months) use of bolus insulin
             injections, whether given separately or as part of a combination with basal insulin,
             e.g. premix insulin; For insulin-naïve individuals: current or previous insulin use
             except for a maximum of 10 consecutive days (e.g. acute illness, surgery) during the
             last year prior to screening.

          -  Cognitive disorder and dementia assessed clinically and by Mini-Mental State
             Examination (MMSE) score <24, or any neurologic disorder that would likely affect the
             participant's ability to follow the study procedure. The participant would be eligible
             despite an MMSE score <24 if the investigator determined that the low score reflected
             educational or cultural background and not dementia as long as the participant was
             otherwise able to meet the study requirements.

          -  Participants who had end-stage renal disease (<15 mL/min/1.73m^2, per estimated
             Glomerular filtration rate (eGFR) measurement by Modification of Diet in Renal Disease
             (MDRD).

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.