• S Garg, T Bailey, T DeLuzio, and D Pollom.
• Barbara Davis Center for Childhood Diabetes, University of Colorado Denver, Aurora, CO 80045, USA. satish.garg@ucdenver.edu
• Curr Med Res Opin. 2011 Dec 1; 27 (12): 232323332323-33.

BackgroundThe prevalence of diabetes is increasing in the United States and worldwide. Insulin injection pens are preferred over vial/syringe methods, and are designed to facilitate use, improve adherence, and provide accurate insulin delivery.ObjectiveThis study compares the efficacy, safety profile, and patient preference of the new prefilled insulin pen FT* versus the original insulin pen FP.MethodsThis randomized, multicenter, open-label, crossover study was conducted in insulin-treated pen-naïve patients with type 1 or type 2 diabetes mellitus (n = 242, mean age 58 years, mean body mass index (BMI) 31.4 kg/m(2), baseline glycosylated hemoglobin [HbA(1c)] 7.3%). Patients were randomized 1:1 to either FT or FP for 12 weeks and then switched to the alternate insulin device for 12 weeks, while the insulin regimen was kept the same. All subjects were on either insulin detemir alone or in combination with insulin aspart treatment during the trial. HbA(1c) was assessed at screening, randomization, cross-over period, and end of trial. The safety profile was evaluated based on adverse events (AEs), adverse device effects (ADEs), and hypoglycemic episodes. Patient-reported outcome (PRO) questionnaires assessed at randomization, crossover period, and end of trial were used to investigate the subjects' preference of the two prefilled devices.ResultsA total of 400 subjects were screened, 242 subjects were randomized and exposed to the prefilled pen devices, and 222 subjects completed the trial. Twenty subjects discontinued the study. Four subjects discontinued due to adverse events. Subject default (withdrawal of consent and loss to follow up) was the most common reason for discontinuation (10 subjects), Glycemic control achieved with FT was comparable to that with FP (FT-FP: difference -0.047 [95% CI -0.127; 0.032%]). The majority of subjects (68%) indicated a preference for the FT device over FP. In addition, the majority of subjects found FT easier to use (64% [144/226]), easier to inject the insulin dose (65% [148/227]) and easier to push for injection (69% [155/226]). The Treatment Related Impact Measure-Diabetes (TRIM-D) ratings of FT were significantly higher for diabetes management facilitation (P < 0.001), and treatment burden (P < 0.001). The safety profiles were comparable for FT and FP.ConclusionsFT was found to be comparable to FP with respect to the efficacy and safety profile. Significantly more subjects favored the FT device in terms of ease of use, insulin injection, diabetes management, and overall preference. A limitation of the present study was its open-label design because the pen devices used to administer the insulin were distinctively different and the use of a double-dummy design was precluded by the absence of placebo pen devices. The questionnaires about treatment were related to the use of the device and therefore a blinded study was not possible.

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