Comparison of Glycemic Control Among Diabetics Using Three Different Pen Needles

Within each dose group, subjects were randomly assigned at baseline to one of two study arms. One study arm (4/5 mm PN) compared the BD 4mm PN to the 5mm PN, and the other arm (4/8 mm PN) compared the BD 4mm PN to the 8mm PN, in a crossover fashion. Based on the randomization, subjects used either the 4mm or the other assigned PN (5mm or 8mm) for the first 3 weeks, then switched to the alternate PN for the next 3 weeks. Glycemic control was assessed by serum fructosamine (FRU) levels at the end of each 3 week period. Based on their baseline insulin regimen, subjects were also assigned to an insulin dosing group (Low or Regular) to help ensure balance among treatment arms. Requirements for each group were as follows: Low Dose: largest single dose of insulin each day with a pen device must be less than or equal to 20 units. Regular Dose: largest single dose of insulin each day, with a pen device, must be 21-40 units. Explanation of Visits and Timing of Assessments: Visit 1: * Screening * Informed Consent * Demographics * Inclusion /Exclusion * Hemoglobin A1c measurement (HbA1c) Visit 2 (Baseline:) * Insulin dose group assignment (Low dose or Regular dose) * Randomization * Fructosamine blood sample collected * Dispense pen needle (PN) assigned first Visit 3 (approximately 3 weeks after starting first PN) * Pain rated by subject relative to baseline PN * Review Adverse Events (AEs) and reported events of injection site leakage * Fructosamine blood sample collected * Dispense second assigned PN Visit 4 (approximately 3 weeks after starting second PN): * Review AEs and reported events of injection site leakage * Fructosamine blood sample collected * Pain rated relative to previously used PN * Study Completion