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

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 [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.

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 < 0.001), and treatment burden (P < 0.001). The safety profiles were comparable for FT and FP.

Conclusions:

FT 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.

Keywords::

• FlexPen
• FlexTouch
• Insulin
• Pen device
• T1DM
• T2DM

Transparency

Declaration of funding

This study was supported by Novo Nordisk A/S, which was the sponsor and the funding source for the clinical trial reported here. Novo Nordisk A/S was involved in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. Drs Garg, Bailey, and Pollum participated in the design of the study, collection of data, and in data analysis. All of the authors were involved in the interpretation of data, providing support for presenting results, drafting the article and reviewing the article for important intellectual content, and were instrumental in the decision to submit the article for publication. All of the authors had full access to all of the data (including statistical reports and tables) in the study and are responsible for the integrity of the data as well as the accuracy of the data analysis.

Declaration of financial/other relationships

S.G., T.B., and D.P. have disclosed that they have no relevant financial relationships. T.D. has disclosed that he is an employee of Novo Nordisk Inc. None of the authors received honoraria for this publication.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

The authors wish to thank Marcus Niemeyer and Madhu Mawal-Dewan of Novo Nordisk Inc. for writing assistance, assembling tables and figures, and coordinating journal submission requirements; and Watermeadow Medical (New York, NY, USA) for editorial and submission assistance.

Notes

*FlexTouch is a registered trade name of Novo Nordisk A/S, Bagsvaerd, Denmark.

†FlexPen is a registered trade name of Novo Nordisk A/S, Bagsvaerd, Denmark.

*FlexTouch is a registered trade name of Novo Nordisk A/S, Bagsvaerd, Denmark.

†FlexPen is a registered trade name of Novo Nordisk A/S, Bagsvaerd, Denmark.

*KwikPen is a registered trade name of Eli Lilly, Indianapolis, IN, USA.