Comparison of the Effects of a New 32-Gauge×4-mm Pen Needle and a 32-Gauge×6-mm Pen Needle on Glycemic Control, Safety, and Patient Ratings in Japanese Adults with Diabetes

Abstract

This study was designed to evaluate two pen needles (PNs) with the same diameter but different lengths (4 mm and 6 mm) and different needle tip shapes (straight and tapered) to compare their effects on glycemic control, perceived pain, safety, patients' ease of use and preferences, and visual impression. In this prospective, open-label, controlled crossover study, 41 insulin-treated patients with type 1 or type 2 diabetes were randomized into either Group 1 (the 32-gauge × 4-mm PN was used during Study Period 1, then the 32-gauge × 6-mm PN was used during Study Period 2) or Group 2 (the order for using the PNs was reversed). The 32-gauge × 4-mm PN provided an equivalent glycemic control in diabetes patients as the 32-gauge × 6-mm PN, with an equivalent occurrence rate of adverse events. The 32-gauge × 4-mm PN was perceived as significantly less painful and rated as significantly more favorable than the 32-gauge × 6-mm PN according to the survey results on patients' ease of use and preferences and on their visual impressions. The 32-gauge × 4-mm PN was not only as safe and efficacious as the 32-gauge × 6-mm PN, but also was perceived as less painful, easier to use, and more favorable to Japanese adult patients with diabetes.