Comparison of Glycemic Control Among Diabetics Using Three Different Pen Needles

Comparison of Glycemic Control Among Diabetics Using the 4mm x 32G BD Pen Needle Versus the 8mm x 31G BD Pen Needle and the 5mm x 31G BD Pen Needle

Anxiety about needles is a commonly expressed concern by diabetics about beginning insulin therapy. A shorter, thinner pen needle that delivers insulin with the safety and efficacy profile of currently marketed pen needles may appeal to many diabetic patients as the new needle may be perceived as less intimidating and more comfortable. Currently marketed pen needles range in length from 5 to 12.7 millimeters (mm).

The primary purpose of this study was to evaluate whether the investigational 4mm x 32 Gauge(G) pen needle manufactured by Becton, Dickinson and Company (BD) provides equivalent glucose control (as measured by fructosamine levels) as the currently marketed BD 5mm x 31 G and BD 8mm x 31 G pen needles (PN)in diabetic subjects with varying insulin dosage regimens.

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

Inclusion Criteria:

• Insulin requiring diabetics (type 1 or type 2)
• Using a pen device for injections at least once per day, for at least two months prior to baseline (Study Visit Two).
• 18 to 75 years of age, inclusive.
• Body Mass Index from 18 to 50 kg/m², inclusive.
• Hemoglobin A1c from 5.5 to 9.5 percent (%), inclusive.
• Largest single dose of insulin a day less than or equal to 40 units

Exclusion Criteria:

• Current status or history of a medical condition that would contraindicate treatment with the study product or other conditions which, in the opinion of the Investigator, would place the subject at risk or have the potential to confound interpretation of the study results (i.e. recent history of ketoacidosis, hypoglycemic unawareness, etc.).
• Hemophilia or any other disorder which causes excessive bleeding or requires frequent transfusions.
• History of intravenous drug abuse (self-reported).
• Bleeding disorder, hemophilia or subject is currently taking anti-coagulant medications (e.g., heparin, Coumadin®, warfarin).
• Self-reported blood borne infection.
• Pregnant (from medical history only).