Ease of use and patient preference injection simulation study comparing two prefilled insulin pens

Abstract

Objectives:

To determine patient ease of use and preference for the Humalog KwikPen^* (prefilled insulin lispro [Humalog^†] pen, Eli Lilly and Company, Indianapolis, IN, USA) (insulin lispro pen) versus the Next Generation FlexPen^‡ (prefilled insulin aspart [NovoRapid^§] pen, Novo Nordisk A/S, Bagsværd, Denmark) (insulin aspart pen).

Research design and methods:

This was a randomized, open-label, 2-period, 8-sequence crossover study in insulin pen-naïve patients with diabetes. Randomized patients (N = 367) received device training, then simulated low- (15 U) and high- (60 U) dose insulin injections with an appliance. Patients rated pens using an ease of use questionnaire and were asked separately for final pen preferences.

Main outcome measures:

The Insulin Device ‘Ease of Use’ Battery is a 10-item questionnaire with a 7-point scale (higher scores reflect greater ease of use). The primary objective was to determine pen preference for ‘easy to press to inject my dose’ (by comparing composite scores [low- plus high-dose]). Secondary objectives were to determine pen preference on select questionnaire items (from composite scores), final pen preference, and summary responses for all questionnaire items.

Results:

On the primary endpoint, ‘easy to press to inject my dose,’ a statistically significant majority of patients with a preference chose the insulin lispro pen over the insulin aspart pen (68.4%, 95% CI = 62.7–73.6%). Statistically significant majorities of patients with a preference also favored the insulin lispro pen on secondary items: ‘easy to hold in my hand when I inject’ (64.9%, 95% CI = 58.8–70.7%), ‘easy to use when I am in a public place’ (67.5%, 95% CI = 61.0–73.6%), and ‘overall easy to use’ (69.9%, 95% CI = 63.9–75.4%). A statistically significant majority of patients had a final preference for the insulin lispro pen (67.3%, 95% CI = 62.2–72.1%).

Conclusions:

Among pen-naïve patients with diabetes who had a preference, the majority preferred the insulin lispro pen over the insulin aspart pen with regard to ease of use. Study limitations included open-label design and injection simulation, use of an unvalidated questionnaire, and enrollment of mostly insulin-naïve patients.

Key words:

• Diabetes mellitus
• Insulin aspart
• Insulin lispro
• Insulin pen
• Patient preference

Transparency

Declaration of funding

This work was funded by Eli Lilly and Company and is related to clinical study protocol, H8L-MC-IQAH.

Declaration of financial/other relationships

P.E.C. and S.S. have disclosed that they are employees and shareholders of Eli Lilly and Company. V.V. has disclosed that she is an advisor who has previously received honoraria from Eli Lilly and Company. V.V. also has disclosed that she is a consultant to Lilly, Abbott, Diabetes Care, Amylin, Calibra, Cequr, Dexcom, M2 pumps, Intuity, PamLab, Tandem and Tethys; and that she is on the speakers’ bureau of Amylin, Lilly, Dexcom, Roche and Tethys. J.N.B. has disclosed that she is an employee of i3 Statprobe, an Ingenix company and subsidiary of UnitedHealth Group, which is contracted by Eli Lilly and Company.

Some peer reviewers receive honoraria from CMRO for their review work. The peer reviewers of this paper have disclosed that they have no relevant financial relationships.

Acknowledgment

The authors thank Tina Rees, PhD and Elizabeth Van Sant Hoffman, PharmD (Eli Lilly, Indianapolis, IN, USA) for critical review of the manuscript, and Joseph Durrant (i3 Statprobe, Ann Arbor, MI, USA) for assistance with manuscript editing and preparation.

Notes

* Humalog KwikPen is a registered trademark of Eli Lilly and Company, Indianapolis, IN, USA.

† Humalog is a registered trademark of Eli Lilly and Company, Indianapolis, IN, USA.

‡ Next Generation FlexPen is a registered trademark of Novo Nordisk A/S, Bagsværd, Denmark.

§ NovoRapid is a registered trademark of Novo Nordisk A/S, Bagsværd, Denmark.

* Humalog KwikPen is a registered trademark of Eli Lilly and Company, Indianapolis, IN, USA.

† Humalog is a registered trademark of Eli Lilly and Company, Indianapolis, IN, USA.

‡ Next Generation FlexPen is a registered trademark of Novo Nordisk A/S, Bagsværd, Denmark.

§ NovoRapid is a registered trademark of Novo Nordisk A/S, Bagsværd, Denmark.

* Ultrafine is a trademark of BD Becton, Dickinson and Company, Franklin Lakes, NJ, USA.

† Novofine is a registered trademark of Novo Nordisk A/S, Bagsværd, Denmark.

* Novolog FlexPen is a registered trademark of Novo Nordisk A/S, Bagsværd, Denmark.