Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: HOE901-U300 (new formulation of insulin glargine); Lantus (insulin glargine)
Intervention description: HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter [mg/dL]).; Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).
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: 878.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of
      change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants
      with type 2 diabetes mellitus

      Secondary Objectives:

      To compare a new formulation of insulin glargine and Lantus in terms of:

      - occurrence of nocturnal hypoglycemia
    

Eligibility criteria:

        Inclusion criteria :

          -  Adult participants with type 2 diabetes mellitus inadequately controlled with
             non-insulin antihyperglycemic drug(s);

          -  Signed written informed consent.

        Exclusion criteria:

          -  HbA1c less than (<) 7.0% (< 53 millimole per mole [mmol/mol]) or greater than (>) 11%
             (> 97 mmol/mol)

          -  History of type 2 diabetes mellitus for less than 1 year before screening

          -  Less than 6 months before screening with non-insulin antihyperglycemic treatment

          -  Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before
             screening

          -  Initiation of new glucose-lowering medications and/or weight loss drug in the last 3
             months before screening visit and/or initiation of Glucagon-like peptide-1 (GLP-1)
             receptor agonist in the last 6 months before screening visit

          -  Participants receiving only non-insulin antihyperglycemic drugs not approved for
             combination with insulin according to local labeling/local treatment guidelines and/or
             sulfonylurea or glinide (Note: non-insulin antihyperglycemic drugs not approved for
             combination with insulin, sulfonylurea and glinide are to be discontinued at baseline)

          -  Current or previous insulin use except for a maximum of 8 consecutive days (for
             example, acute illness, surgery) during the last year prior to screening

          -  Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic
             retinopathy or macular edema likely to require treatment (for example, 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.