Novo Nordisk A/S

Xultophy® (insulin degludec/liraglutide; IDegLira) is cost-effective versus current basal insulin intensification in people with uncontrolled type 2 diabetes in the UK

Glasgow, Scotland (ots/PRNewswire) - This material is intended for European and UK medical media only.

For journalistic assessment and preparation before publication.

New findings show that Xultophy® (insulin degludec/liraglutide; IDegLira), the first once-daily combination of a long-acting basal insulin (Tresiba®?/insulin degludec) and a glucagon-like peptide-1 receptor agonist (Victoza®/liraglutide) in one pen, is cost-effective[*] versus current insulin intensification treatment options for the treatment of people in the UK with type 2 diabetes who are uncontrolled on basal insulin.[1] These health economics and outcomes research findings were presented today at the Diabetes UK Professional Conference in Glasgow, Scotland.

The analysis assessed the cost-effectiveness of IDegLira compared to an up-titration of insulin glargine U100, separate injections of liraglutide added to basal insulin (insulin glargine U100 or insulin detemir), or insulin glargine U100 in combination with three daily injections of insulin aspart (basal-bolus).[1] This analysis was performed from the perspective of the UK NHS over a lifetime horizon.

"In the UK, 69% of people with type 2 diabetes treated with basal insulin do not achieve glycaemic control," said Melanie Davies, Professor of Diabetes Medicine, University of Leicester, UK. "It is useful for clinicians that cost-effective combination treatments such as IDegLira are available as they have been shown to help patients achieve optimal glycaemic targets and may help prevent complications."

On average, in the UK, daily administration of IDegLira cost less in total and was more effective compared to the separate injections of liraglutide added to basal insulin or compared to basal-bolus regimens. IDegLira was also cost-effective versus up-titration of insulin glargine U100, with a cost of £6,090 per quality-adjusted life year [QALY] gained, which is well below the UK threshold of £20,000 to £30,000 used by NICE.[1] QALYs are commonly used in health economic evaluations to measure the additional health benefits achieved.

About the data sources

Patient data for the present analysis were sourced from the DUAL V clinical trial and a pooled analysis study of five completed Novo Nordisk randomised clinical trials in patients with type 2 diabetes inadequately controlled on basal insulin.[2],[3]

DUAL V was a phase 3b, 26-week, treat-to-target, randomised, open-label, multicentre trial conducted in 10 countries with 557 patients. The trial was designed to show non-inferiority in HbA1c and to subsequently demonstrate superiority in HbA1c, body weight and rate of hypoglycaemia. The trial compared the efficacy and safety of IDegLira versus insulin glargine U100, both added on to metformin, in adults with type 2 diabetes uncontrolled on insulin glargine U100 (20-50 units). The pretrial mean dose of insulin glargine U100 was 32 units. Patients could be titrated to the maximum dose of IDegLira (equivalent to 50 units of insulin degludec and 1.8 mg of liraglutide) and there was no maximum daily dose of insulin glargine U100. [3]

The pooled analysis is based on individual patient level data from five systematically selected trials: DUAL II (NCT01392573), LIRA-ADD2BASAL (NCT01617434), BEGIN BB Type 2 (NCT00972283), BEGIN FLEX (NCT01006291), BOOST®: INTENSIFY BASAL (NCT01045447). Standard multivariate analyses were applied to adjust for differences in patient characteristics between studies to ensure comparability.[2]

[*]Cost-effectiveness is defined as the value of an intervention - the costs incurred as a result of that intervention divided by the health outcomes achieved.

About Xultophy®

Xultophy® is a once-daily single injection combination of Tresiba® (insulin degludec), a once-daily basal insulin analogue, and Victoza® (liraglutide), a once-daily human GLP-1 analogue.[4] The maximum dose of Xultophy® is 50 dose steps (equivalent to 50 units of insulin degludec and 1.8 mg of liraglutide). Xultophy® is being investigated in the DUAL clinical trial programme, which includes two phase 3a and a number of phase 3b trials, encompassing more than 3,500 people with type 2 diabetes. Xultophy® was granted marketing authorisation by the European Commission on 18 September 2014 and approved in Switzerland on 12 September 2014.[4],[5] Xultophy® has also been accepted for restricted use in people with type 2 diabetes uncontrolled on basal insulin in NHS Scotland and Wales by the Scottish Medicines Consortium and All Wales Medicines Strategy Group, respectively.[6],[7]

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 41,000 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.co.uk (http://www.novonordisk.co.uk).

?: This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See http://www.MHRA.gov.uk/yellowcard for how to report side effects.

References

1. Davies MJ, McEwan P, Glah D, et al. Cost-effectiveness analysis of insulin degludec/liraglutide (IDegLira) vs other basal insulin intensification strategies in type 2 diabetes patients uncontrolled on basal insulin in a United Kingdom setting. P404 at the 2016 Diabetes UK Conference, Glasgow, UK; 2-4 March 2016.

2. Freemantle N, Mamdani M, Vilsboll T, et al. IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy. Diabetes Ther. 2015; 6:573-591

3. Buse JB, Perez Manghi FC, Garcia-Hernandez PA, et al. Insulin degludec/liraglutide (IDegLira) is superior to insulin glargine (IGlar) in HbA1c reduction, risk of hypoglycaemia and weight change: DUAL V Study. Diabetologia. 2015; 58(Suppl.1):S402-403

4. EMA. Xultophy® summary of product characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002647/WC500177657.pdf Last accessed: February 2016.

5. SwissMedic. Xultophy®: information for professionals. 2014.

6. All Wales Medicines Strategy Group. Final Appraisal Recommendation on insulin degludec/liraglutide. Available at: http://www.awmsg.org/awmsgonline/grabber;jsessionid=dbdb1976caf832626d59aae3ab8f?resId=2015 Last accessed: February 2016.

7. Scottish Medicines Consortium. Advice on insulin degludec/liraglutide. Available at: http://www.scottishmedicines.org.uk/files/advice/insulin_degludec_liraglutide__Xultophy_FINAL_Sept_2015_for_website.pdf Last accessed: February 2016.

Further Information

Media:

Stephen Cull  +44-7584-447-280  scul@novonordisk.com 
Mario Christodoulou  +44-7789-507-812  mciu@novonordisk.com 
Investors:  Peter Hugreffe Ankersen  +45-3075-9085  
phak@novonordisk.com 
Melanie Raouzeos  +45-3075-3479  mrz@novonordisk.com 
Daniel Bohsen  +45-3079-6376  dabo@novonordisk.com

 
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