Preference for a new prefilled insulin pen compared with the original pen

• Published in: Current medical research and opinion 2011-12, Vol.27 (12), p.2323-2333
• Main Authors: Garg, S., Bailey, T., DeLuzio, T., Pollom, D.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Cross-Sectional Studies; Diabetes Mellitus, Type 1 - blood; Diabetes Mellitus, Type 1 - drug therapy; Double-Blind Method; Female; FlexPen; FlexTouch; Follow-Up Studies; Glycated Hemoglobin A - metabolism; Humans; Hypoglycemia - blood; Hypoglycemia - chemically induced; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - adverse effects; Injections, Intradermal - adverse effects; Injections, Intradermal - instrumentation; Injections, Intradermal - methods; Insulin; Insulin - administration & dosage; Insulin - adverse effects; Male; Middle Aged; Patient Compliance; Pen device; Surveys and Questionnaires; T1DM; T2DM
• ISSN: 0300-7995; 1473-4877
• DOI: 10.1185/03007995.2011.630721

Abstract Background: The 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. Objective: This study compares the efficacy, safety profile, and patient preference of the new prefilled insulin pen FT* *FlexTouch is a registered trade name of Novo Nordisk A/S, Bagsvaerd, Denmark. versus the original insulin pen FP.† †FlexPen is a registered trade name of Novo Nordisk A/S, Bagsvaerd, Denmark. Methods: This 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/m2, baseline glycosylated hemoglobin [HbA1c] 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. HbA1c 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. Results: A 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