Tresiba® Reduces Hypoglycaemia Regardless of Blood Sugar Level

10 dicembre 2017

- People with either type 1 or type 2 diabetes treated with Tresiba® had fewer episodes of low blood sugar (hypoglycaemia) compared with people on insulin glargine U100 regardless of whether they had achieved blood sugar targets.[1] These new post-hoc analyses from the SWITCH 1 and 2 trials were presented at the International Diabetes Federation (IDF) Annual Congress in Abu Dhabi today.[2],[3] "Achieving target blood sugar levels can be a constant challenge for people with diabetes treated with insulin, and this is made even more complex by the risk of hypoglycaemia," said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk. "Tresiba® has consistently been shown to provide stable blood sugar control while at the same time reducing hypoglycaemia compared with insulin glargine U100; it is very encouraging to see that treatment with Tresiba® helps people to achieve blood sugar control with fewer episodes of hypoglycaemia regardless of their blood sugar levels in this analysis." The findings of these analyses are consistent with the results of the main SWITCH trials which demonstrated significantly lower rates of overall symptomatic hypoglycaemia versus insulin glargine U100 in people with type 1 and type 2 diabetes.[2],[3] About hypoglycaemia Hypoglycaemia occurs when blood sugar levels are too low and cannot provide the body's organs with the energy they need. Hypoglycaemia can cause a range of symptoms including confusion, trembling, sweating, increased heart rate, difficulty with concentration and/or speech and in severe cases can lead to a seizure or coma.[4]-[6] Severe hypoglycaemia can cause extensive damage to the body and is significantly associated with cardiovascular death.[7] Every month, 46.5% of people with type 2 diabetes and 83.0% of people with type 1 diabetes experience a hypoglycaemic episode.[8] About the new analyses The analyses, based on the recent SWITCH trials, separated people into two groups depending on whether they had achieved target blood sugar levels (defined as HbA1c of 7.0% or less) during the maintenance period of the trial.[1] Target blood sugar levels are those recommended by the joint guidelines of the American Diabetes Association and the European Association for the Study of Diabetes.[9] About SWITCH 1 and 2 SWITCH 1 and SWITCH 2 were two phase 3b, 64-week, double-blind, randomised, treat-to-target, 2-period crossover trials that investigated the hypoglycaemia profile of Tresiba® compared with insulin glargine U100 in people with type 1 and type 2 diabetes, respectively. The trial design included a titration period in which the doses of study treatments (Tresiba® or insulin degludec U100) were gradually increased over a 16 week period, followed by a 16 week maintenance period during which a constant dose of study treatment was maintained.[2],[3] The primary endpoint was the number of severe or blood glucose-confirmed symptomatic hypoglycaemic episodes observed in participants during the maintenance period.[2],[3] About Tresiba® Tresiba® (insulin degludec) is a once-daily basal insulin that provides a duration of action beyond 42 hours with a flat and stable glucose-lowering effect.[10],[11] It has been shown to provide a lower risk of overall, nocturnal and severe hypoglycaemia, and low variability in blood glucose levels versus insulin glargine U100.[11],[12] Tresiba® received its first regulatory approval in September 2012 and has since been approved in more than 80 countries globally. It is now commercially available in more than 50 countries. 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] References 1. Gumprecht J, Lane W, Chaykin LB, et al. Lower rate of hypoglycaemia with insulin degludec vs. insulin glargine U100 after adjusting for HbA1c in SWITCH 1 and 2. Poster presentation. International Diabetes Federation (IDF) Annual Congress 2017, Abu Dhabi, UAE. December 2017. 2. Lane W, Bailey TS, Gerety G, et al. Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 1 diabetes: The SWITCH 1 randomized clinical trial. JAMA. 2017;318:33-44. 3. Wysham C, Bhargava A, Chaykin L, et al. Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 2 diabetes: The SWITCH 2 randomized clinical trial. JAMA. 2017;318:45-56. 4. Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013;36:1384-1395. 5. International Hypoglycaemia Study Group. Diagnosis of hypoglycaemia. Available online at http://ihsgonline.com/understanding-hypoglycaemia/diagnosis. Last accessed November 2017. 6. Cryer P. Hypoglycemia, functional brain failure, and brain death. Journal of Clinical Investigation. 2007;117:868-870. 7. Pieber TR, Marso SP, McGuire DK, et al. DEVOTE 3: temporal relationships between severe hypoglycaemia, cardiovascular outcomes and mortality. Diabetologia. 2017. 8. Khunti K, Alsifri S, Aronson R, et al. Rates and predictors of hypoglycaemia in 27 585 people from 24 countries with insulin-treated type 1 and type 2 diabetes: the global HAT study. Diabetes Obes Metab. 2016;18:907-915. 9. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of Hyperglycemia in Type 2 Diabetes, 2015: A Patient Centered Approach. Diabetes Care 2015;38:140-149. 10. Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet. 2014;53:787-800. 11. EMA. Tresiba® Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002498/WC500138940.pdf. Last accessed: November 2017. 12. Marso SP, McGuire DK, Zinman B, et al. Efficacy and safety of degludec versus glargine in type 2 diabetes. N Engl J Med. 2017;377:723-732.