Patient Preference and Satisfaction With Insulin Glargine (Lantus) Solostar Pen vs Conventional Vial-Syringe Method of Lantus Injection Therapy in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Glargine
Intervention description: Pharmaceutical form: solution for injection
Route of administration: subcutaneous
Intervention MeSH terms: Insulin Glargine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 405.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To assess patient preference for Lantus SoloSTAR pen versus Lantus vial and syringe at the
      end of Crossover Phase (Week 4) in patients with type 2 diabetes mellitus (T2DM)

      Secondary Objectives:

      To compare Lantus SoloSTAR pen versus Lantus vial and syringe with regard to the following
      parameters:

      Randomization/Crossover phase:

        -  Healthcare professional's (HCP) recommendation for Lantus SoloSTAR pen versus Lantus
           vial and syringe

      Re-randomization phase:

        -  Change in Fasting Plasma Glucose (FPG) from week 4 to week 10

        -  Percentage of patients achieving FPG<110 mg/dL at week 10

        -  Change in Lantus dose injected per day (U) from week 4 to week 10

      Observational phase:

        -  Percentage of patients achieving glycosylated hemoglobin (HbA1c) goal (<7%) at week 40

        -  Time to first observation of HbA1c<7% during the observational phase

        -  Percentage of patients who discontinue Investigational Product (IP) during the
           observational phase due to dissatisfaction with their current device

      All phases:

        -  Percentage of patients who discontinue IP during each phase of the study

        -  Safety assessment such as occurrence of hypoglycemic events (HE) and adverse events (AE)
    

Eligibility criteria:

        Inclusion criteria:

        Patients with a confirmed diagnosis of type 2 diabetes mellitus who were treated with any
        combination of 2 or 3 oral antidiabetic drugs (OADs) at a stable dose for the preceding 3
        months, including but not limited to:

          -  Metformin + sulfonylurea + thiazolidinedione (Pioglitazone)

          -  Metformin + sulfonylurea

          -  Metformin + thiazolidinedione (Pioglitazone)

          -  Metformin + dipeptidyl peptidase (DPPIV)

        And for whom the Investigator/treating physician had decided that basal insulin was
        appropriate.

        Patients who had signed an Informed Consent Form and Health Insurance Portability and
        Accountability Act (HIPAA) Authorization Form

        Exclusion criteria:

          -  Patients less than 18 years or greater than 85 years of age (ie, have not reached the
             age of 86 at the screening visit)

          -  Patients with a confirmed diagnosis of type 1 diabetes mellitus

          -  Patients who were treated with insulin or who had been treated with insulin in the
             preceding 12 months with the exception of insulin treatment during hospitalization
             (ie, patients who received insulin while hospitalized could be included)

          -  Patients whose screening HbA1c is <7% or >10%

          -  Patients with current addiction or current alcohol / drug abuse

          -  Patients with cardiac status New York Heart Association III-IV

          -  Patients with stroke, myocardial infarction, coronary artery bypass graft,
             percutaneous transluminal coronary angioplasty, or unstable angina pectoris within the
             12 months prior to screening

          -  Patients with a diagnosis of dementia, severe visual or dexterity impairment

          -  Patients with any malignancy within the last 5 years, with the exception of adequately
             treated basal or squamous cell carcinoma of the skin or adequately treated cervical
             carcinoma in situ

          -  Patients with concomitant disease or concomitant medication that could interfere with
             treatment or ability to answer questionnaires

          -  Patients who were unable to self-inject

          -  Patients who were taking or had been treated with Byetta® (exenatide) or other
             Glucagon-Like Peptide-1 agonists within 3 months before screening:

          -  Patients who were pregnant or breastfeeding

          -  Women of childbearing potential not protected by a highly effective contraceptive
             method of birth control (as defined for contraception in the Informed Consent Form and
             /or in a local protocol addendum) and/or who were unwilling or unable to be tested for
             pregnancy

          -  Patients with impaired renal function as shown by serum creatinine ≥1.5 mg/dL for
             males or ≥1.4 mg/dL for females at screening

          -  Patients with clinical evidence of active liver disease, or serum alanine
             aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit
             of the normal range (ULN)

          -  Patients unlikely to comply with the protocol requirements (eg, illiterate,
             uncooperative, unable to return for scheduled visits, unlikely to complete the study)