COPENHAGEN, Denmark, December 4, 2017 /PRNewswire/ --
New findings from an indirect comparison between Xultophy®
"In the absence of a head-to-head trial between Xultophy® and IGlarLixi, the solid methodology of this indirect comparison, where we adjusted for key differences between study designs and patient populations, allows us to conclude that Xultophy® can deliver greater reductions in the overall blood sugar levels and weight for people with type 2 diabetes who are uncontrolled on basal insulin, compared to IGlarLixi," said lead study author Professor Marc Evans of University Hospital, Llandough in Cardiff, UK. "This analysis is based on published data from individual clinical trials which involved over 700 adults living with type 2 diabetes."
This indirect comparison showed that, within the study population, people with type 2 diabetes uncontrolled on basal insulin achieved a 0.44% greater reduction of their overall blood sugar levels (HbA1c), and a 1.42 kg greater weight loss when treated with Xultophy®, compared to those treated with IGlarLixi, at similar doses of insulin. Additionally, the analysis found a higher likelihood of reaching target blood sugar levels (HbA1c <7%) with Xultophy®, compared to IGlarLixi.
About the analysis
This analysis was an indirect comparison using published data from phase 3 trials providing evidence for estimating the relative efficacy and safety of Xultophy® versus IGlarLixi in people with type 2 diabetes uncontrolled on basal insulin. Outcomes of interest were change in HbA1c, body weight, insulin dose and rate ratio of hypoglycaemia. Xultophy® was estimated to provide a 0.44% point reduction in HbA1c compared with IGlarLixi [95%CI: 0.17, 0.71]. Body weight was reduced by 1.42 kg with Xultophy®, compared to IGlarLixi [95%CI: 0.35, 2.50].
The results mentioned above were achieved at similar insulin doses. The rate of severe or blood glucose-confirmed hypoglycaemia with Xultophy® was approximately half that of IGlarLixi (rate ratio 0.51 [95%CI: 0.29, 0.90]. Rate ratios for severe or BG-confirmed hypoglycaemia are based on a target of ?3.1 mmol/L in the Xultophy® trials and ?3.3 mmol/L in the IGlarLixi trial). However, using the American Diabetes Association definition of documented symptomatic hypoglycaemia (SMPG ?3.9 mmol/L) the rate was comparable between the two treatments (rate ratio 1.07 [95%CI: 0.90, 1.28]). Limitations of this indirect comparison include: differences in study design, patient characteristics and the definition of hypoglycaemia.
The article published in the Journal of Medical Economics can be accessed online at: http://dx.doi.org/10.1080/13696998.2017.1409228.
Xultophy® is a once-daily single injection fixed-ratio combination of long-acting insulin degludec and the glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide in one pen. It is indicated for the treatment of adults with type 2 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. Xultophy® is given once daily by subcutaneous injection. Xultophy® can be administered at any time of the day with or without meals, preferably at the same time of the day.
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 obesity, haemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs approximately 41,700 people in 77 countries and markets its products in more than 165 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
Further information Media: Katrine Sperling +45-4442-6718 [email protected]
Åsa Josefsson +45-3079-7708 [email protected] Investors: Peter Hugreffe Ankersen +45-3075-9085 [email protected] Hanna Ögren +45-3079-8519 [email protected] Anders Mikkelsen +45-3079-4461 [email protected] Christina Kjær +45-3079-3009 [email protected] Kasper Veje (US) +1-609-235-8567 [email protected]
1. Evans M, Billings LK, Håkan-Bloch J, et al. An indirect treatment comparison of the efficacy of insulin degludec/liraglutide (IDegLira) and insulin glargine/lixisenatide (iGlarLixi) in patients with type 2 diabetes uncontrolled on basal insulin. Journal of Medical Economics. 2017;Published online ahead of print.
2. 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: November 2017.
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