Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin glargine, 300U/mL; Insulin degludec, 100 U/mL; Non-insulin anti-diabetic treatment
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 80 to 100 mg/dL (4.4 to 5.6 mmol/L).; 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 80 to 100 mg/dL (4.4 to 5.6 mmol/L).
Route of administration: subcutaneous; Background therapy: Oral Anti diabetics Drugs (OADs), Glucagon-like peptide-1 (GLP-1) receptor agonist.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Hypoglycemic Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 929.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated
      hemoglobin (HbA1c) change from Baseline to Week 24.

      Secondary Objectives:

      Change From Baseline in HbA1c to Week 12

      To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® at week 12
      and week 24 on:

        -  Change in Fasting plasma glucose (FPG);

        -  Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point SMPG
           profile;

        -  Percentage of participants reaching HbA1c targets <7% or ≤6.5%;

        -  Percentage of participants reaching HbA1c targets <7% or ≤6.5% without severe and/or
           confirmed hypoglycemia

        -  Frequency of occurrence and diurnal distribution of hypoglycemia by American Diabetes
           Association (ADA) category of hypoglycemia.

      To assess the safety in each treatment group.

      To assess the treatment effects in each treatment group on Patient Reported Outcomes (PRO).

      Percentage of participants requiring rescue therapy.
    

Eligibility criteria:

        Inclusion criteria :

          -  Adult participants with type 2 diabetes mellitus (T2DM) inadequately controlled with
             OADs therapy with/without GLP-1 receptor agonist at stable dose for at least 3 months.

          -  Signed written informed consent.

        Exclusion criteria:

          -  Age <18 years.

          -  HbA1c <7.5% or >10.5% (at screening visit). Body mass index (BMI) <25 kg/m^2 or >40
             kg/m^2.

          -  History of T2DM for less than 1 year before screening.

          -  Less than 6 months before screening on OADs treatment and GLP-1 receptor agonist (if
             taken).

          -  Current or previous insulin use except for a maximum of 8 consecutive days or totally
             15 days (eg, acute illness, surgery) during the last year prior to screening.

          -  Initiation of new glucose-lowering medications and/or weight loss drug in the last 3
             months before screening visit.

          -  Participant receiving only noninsulin antihyperglycemic drugs not approved for
             combination with insulin according to local labelling/local treatment guideline.

          -  History of hypoglycemia unawareness or repeated episodes of severe hypoglycemia or
             metabolic acidosis, including hospitalization for diabetic ketoacidosis during the
             last 12 months prior to screening.

          -  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.

          -  End stage renal disease.

          -  Any acute or chronic condition that in the opinion of Investigator would affect the
             safety of participant, compliance, or study results.

          -  Any contraindication to use of Toujeo® or Tresiba® as defined in the national product
             label, hypersensitivity to Toujeo® or Tresiba® active ingredients or one of the
             excipients.

          -  Pregnant or breast-feeding women.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.