New treatment can help adults with type II diabetes achieve better glycaemic control

Novo Nordisk announced that Xultophy® (insulin degludec/liraglutide; IDegLira), the first ever treatment combining two existing treatments, long acting (basal) insulin (insulin degludec, Tresiba®) (1) and GLP-1 receptor agonist (liraglutide, Victoza®) (2) in one pen, has been launched in the United Kingdom.

Xultophy® is indicated for the treatment of adults with type II diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with basal insulin do not provide adequate glycaemic control. (3)

Adults with type II diabetes taking once-daily Xultophy® (pronounced Zol-toe-fy) had a significant improvement in blood sugar (measured by HbA1c). (4) Additionally, Xultophy® was shown to have a secondary benefit of weight loss* and a low rate of hypoglycaemia (very low blood sugar), comparable to Tresiba®. (5)

In the UK, nearly three quarters of people with type II diabetes on basal insulin regimens fail to reach the recommended target for HbA1c of 58mmol/mol (≤7.5%) and are therefore at a greater risk of complications. (6–10) Despite this, market research data for the year to September 2014 show that two thirds (67%) of people with type II diabetes who were prescribed long-acting insulin (as the only insulin) had no change to their insulin prescription during that 12-month period**. (11)

Insulin is an effective diabetes treatment, but it is often delayed due to the risk or fear of hypoglycaemia – and also possible weight gain. (12) A reduction in HbA1c can provide both a huge personal benefit and a significant cost saving through the reduction of complications. A one percentage point drop in HbA1c can lead to a 37% reduction in microvascular complications, a 14% reduction in myocardial infarctions and a 21% reduction in overall diabetes-related mortality. (9)

Professor Steve Bain, Professor of Medicine (Diabetes) at Swansea University and Clinical Lead for the Diabetes Research Network, Wales, commented: “The availability of Xultophy® is a positive step forward, providing a new treatment option for the many people in the UK with type II diabetes who struggle to control their blood sugar. This has the potential to reduce complications and help ease the significant cost burden on the NHS.”

When taking Xultophy® in a Phase III trial over 26 weeks, people struggling to control their blood sugar on long acting insulin and oral diabetes medication were shown to have:

• Significant improvement in blood sugar (1.9% reduction in HbA1c) (5)
• Secondary benefits of:
• Weight loss of 2.7kg from baseline (5)*
• Low rate of hypoglycaemia comparable to Tresiba® (1,5)

Type II diabetes affects three million people in the UK and this is expected to rise to five million in 2025. (13) Type II diabetes currently costs the NHS over £10 billion per year, with around 80% of this cost because of often preventable complications. (14) These include blindness, amputations and kidney failure.

Commenting on the availability of Xultophy®, Gwen Hall, Diabetes Specialist Nurse, Haslemere Health Centre, Surrey said: “Many people with type II diabetes would benefit from intensifying their basal insulin treatment but face additional barriers in terms of hypoglycaemia, weight gain and a potential increase in the number of daily injections they have to take, meaning their diabetes is not optimally controlled. The data from the clinical trials suggest that once-daily Xultophy® could help to reduce some of the obstacles people face and it is very welcome news that it is available for patients.”

Xultophy® is now available in the UK.

References

1. Tresiba® Summary of Product Characteristics (SPC). Bagsværd, Denmark, Novo Nordisk A/S; 2014.
2. Victoza® Summary of Product Characteristics (SPC). Bagsværd, Denmark, Novo Nordisk A/S; 2014.
3. EMA Summary of Opinion http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002647/WC500170171.pdf (Last accessed 27 May 2015).
4. Gough S et al. Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes. Lancet Diabetes Endocrinol 2014;2(11):885–93.
5. Buse JB et al. Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide (IDegLira). Diabetes Care 2014;37(11):2926–33.
6. Blak BT et al. A retrospective database study of insulin initiation in patients with Type 2 diabetes in UK primary care. Diabet Med 2012;29(8):e191–8.
7. Novo Nordisk. Data on file.
8. International Diabetes Federation. 2013. Available at: http://www.idf.org/diabetesatlas (Last accessed 15 January 2015).
9. Stratton IM et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000;321(7258):405–12.
10. Bethel MA and Feinglos MN. Basal Insulin Therapy in Type 2 Diabetes. J Am Board Fam Med 2005:18(3);199-204.
11. CSD Patient Data MAT September 2014, Cegedim Strategic Data Limited.
12. Khunti K et al. Clinical Inertia in People with Type 2 Diabetes. Diabetes Care 2013;36:3411-17.
13. Diabetes UK. State of the Nation 2014. http://www.diabetes.org.uk/Documents/About%20Us/What%20we%20say/State%20of%20the%20nation%202014.pdf (Last accessed 14 January 2015).
14. Hex N et al. Estimating the current and future costs of Type 1 and Type 2 diabetes in the UK, including direct health costs and indirect societal and productivity costs. Diabet Med 2012;29(7):855–62.
15. Gough S et al. One-year efficacy and safety of IDegLira in patients with type 2 diabetes. Diabetes 2014;63 (Suppl. 1):A117(65OR).