Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin
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 mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter [mg/dL]). After 6 months participants were proposed to participate to the administration substudy and to receive either HOE901-U300 once daily at intervals of 24 +/- 3 hours (adaptable dosing intervals) or to continue once daily injections of HOE901-U300 every 24 hours (fixed dosing intervals) up to Month 9.; Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of mealtime insulin analogue. 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: 807.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

        -  To compare the efficacy of insulin glargine new formulation and Lantus in terms of
           change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with
           type 2 diabetes mellitus

      Secondary Objectives:

        -  To compare the efficacy of insulin glargine new formulation and Lantus in terms of
           occurrence of nocturnal Hypoglycemia
    

Eligibility criteria:

        Inclusion criteria :

          -  Participants with type 2 diabetes mellitus

          -  Substudy inclusion criteria:

               -  Completion of the 6-month study period in main study (Visit 10)

               -  Randomized and treated with insulin glargine new formulation during the 6-month
                  treatment period (Baseline - month 6)

        Exclusion criteria:

          -  Age less than (<) 18 years

          -  HbA1c <7.0% or greater than (>) 10% at screening

          -  Diabetes other than type 2 diabetes mellitus

          -  Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose

          -  Any contraindication to use of insulin glargine as defined in the national product
             label

          -  Participants using human regular insulin as mealtime insulin in the last 3 months
             before screening visit

          -  Use of an insulin pump in the last 6 months before screening visit

          -  Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3
             months before screening visit

          -  History or presence of significant diabetic retinopathy or macular edema likely to
             require laser or injectable drugs or surgical treatment during the study period

          -  Pregnant or breast-feeding women or women who intend to become pregnant during the
             study period

          -  Substudy exclusion criteria:

               -  Participant not willing to use the adaptable injection intervals on at least two
                  days per week

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.