Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Lantus (Insulin glargine); HOE901-U300 (new formulation of insulin glargine)
Intervention description: Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).; HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s). 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.
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: 811.0
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 Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6)
           in adult participants with type 2 diabetes mellitus

      Secondary Objective:

        -  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 6 months on basal insulin treatment together with oral antihyperglycemic
             drug(s) and self-monitoring of blood glucose

          -  Participants using sulfonylurea in the last 2 months before screening visit

          -  Any contraindication to use of insulin glargine as defined in the national product
             label

          -  Use of insulin pump in the last 6 months before screening

          -  Initiation of new glucose-lowering medications 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.