Improvements in quality of life associated with insulin analogue therapies in people with type 2 diabetes: Results from the A1chieve observational study,☆☆

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Abstract

Aims

To determine the effects on quality of life after starting insulin with, or switching to, insulin analogue therapies in the 24-week, prospective, non-interventional, observational A1chieve study conducted across four continents in people with type 2 diabetes.

Methods

Health-related quality of life (HRQoL) was assessed at baseline and at 24 weeks by the validated EQ-5D questionnaire (visual analogue score [VAS] and five dimensions) in 66,726 people who had started using basal insulin detemir, mealtime insulin aspart (with or without a basal insulin) or biphasic insulin aspart 30.

Results

For the overall cohort, reported HRQoL increased significantly by 13.8 points from 63.4 points at baseline to 77.2 points at 24 weeks (p < 0.001) (scale 1–100, 100 = best health imaginable). Beginning or changing insulin was associated with a significant increase in HRQoL score (+15.0 points and +11.1 points, respectively), resulting in a similar score at 24 weeks in the two populations (77.8 and 75.9 points). Reported HRQoL also increased statistically significantly in people administering any insulin analogue regimen and across all regions, although there were some marked regional differences in reported HRQoL at baseline.

Conclusion

Compared with baseline scores, beginning insulin with, or switching to, insulin analogue therapies are associated with increased HRQoL.

Introduction

It is widely recognised that having type 2 diabetes (T2DM) has a negative impact on quality of life (QoL) [1]. Having to deal with lifestyle change, complex treatment regimens, potentially having to manage self-injection, and sometimes fear of hypoglycaemia and weight gain can contribute to poor QoL and adverse perceptions of diabetes therapies [2], [3], [4]. Consequently, people with T2DM and their physicians often delay starting or optimizing insulin therapy, despite the current burdens of poor glycaemic control [4], [5], [6], [7]. Alongside effective glycaemic control, maintaining or improving QoL is an integral part of the successful management of diabetes. Indeed, it is known that measured QoL improves with better glycaemic control [8].

Literature reporting the effect of insulin analogues on QoL is scarce, with one recent systematic review investigating basal insulin analogues being unable to identify any suitable trials measuring QoL in people with T2DM [9].

As the largest observational study ever conducted in insulin therapy, and with a broad geographical base, the A1chieve study evaluated the safety and effectiveness of starting insulin with, or switching to, insulin analogue-based regimens in a large and diverse population from a wide variety of clinical environments [10]. It is then well placed to investigate health-related quality of life (HRQoL). The aim of the current analysis was to determine the effects on HRQoL of insulin analogue therapies in people with T2DM.

Section snippets

Study design

This was a 24-week, international, prospective, non-interventional, observational study of people with T2DM who had begun using biphasic insulin aspart 30 (premix), insulin aspart, or insulin detemir with or without oral glucose-lowering drugs (OGLDs). The study was carried out in 28 countries across four continents (Asia, Africa, Latin America and Europe): Algeria, Argentina, Bahrain, Bangladesh, China, Egypt, India, Indonesia, Iran, Jordan, Kuwait, Libya, Malaysia, Mexico, Morocco, Oman,

Metabolic control and hypoglycaemia

Data for insulin doses, blood glucose control, and body weight change are given in a separate manuscript (Home et al., submitted to Diabetes Res. Clin. Pract., this issue). Broadly, blood glucose control measures improved markedly in both insulin-naïve and prior insulin users, for groups starting insulin detemir, insulin aspart, or biphasic insulin aspart 30, and in all geographical regions (HbA1c change −1.5% to −2.5%). Similarly, reported hypoglycaemia rates were lower for the most part in

Discussion

This analysis of HRQoL, measured by the validated EQ-5D questionnaire, in the international, 24-week A1chieve study found that people with T2DM starting insulin with, or switching to, insulin detemir, insulin aspart, or biphasic insulin aspart 30 experienced significantly increased overall HRQoL, with significant improvements across all five component health dimensions. Irrespective of people's previous insulin experience, the HRQoL significantly improved with the insulin analogues used in this

Contribution

All authors advised on the design and conduct of the study. All authors reviewed the results of the study, and took part in writing and reviewing the manuscript.

Conflicts of interest

Professor Shah is a member of an advisory board panel for Novo Nordisk. Dr. Zilov is an opinion leader and lecturer for Novo Nordisk. Professor Malek is an advisory board member and lectures for Novo Nordisk. Dr. Soewondo is on an advisory panel for Novo Nordisk. Dr. Bech is an employee of Novo Nordisk. Dr. Litwak lectures for Novo Nordisk. This study was sponsored by Novo Nordisk A/S Denmark. The sponsor took part in the development of the protocol, the process of data collection and analysis,

Acknowledgments

The authors would like to thank all investigators involved in the A1chieve study. The authors would like to thank Chunduo Shen of Novo Nordisk for providing statistical analyses. The authors would also like to thank Elizabeth Southey and Natalie Brooks of Watermeadow Medical for writing and editorial assistance, funded by Novo Nordisk.

References (18)

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Cited by (0)

Grant support: The A1chieve study was funded by Novo Nordisk.

☆☆

Clinical trial registration: Clinicaltrials.gov, NCT00869908.

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