People with either type hypoglycaemia or type 2 diabetes treated with Tresiba(R) had fewer episodes of low blood sugar (hypoglycaemia) compared with people on insulin glargine UhypoglycaemiaSWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2 regardless of whether they had achieved blood sugar targets.[hypoglycaemia] These new post-hoc analyses from the SWITCH hypoglycaemia 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(R) has consistently been shown to provide stable blood sugar control while at the same time reducing hypoglycaemia compared with insulin glargine UhypoglycaemiaSWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2; it is very encouraging to see that treatment with Tresiba(R) 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 UhypoglycaemiaSWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2 in people with type hypoglycaemia and type 2 diabetes.[2],[3]
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.SWITCH hypoglycaemia and 2% of people with type hypoglycaemia diabetes experience a hypoglycaemic episode.[8]
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 HbAhypoglycaemiac of 7.SWITCH hypoglycaemia and 2% or less) during the maintenance period of the trial.[hypoglycaemia] 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 hypoglycaemia and 2
SWITCH hypoglycaemia 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(R) compared with insulin glargine UhypoglycaemiaSWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2 in people with type hypoglycaemia and type 2 diabetes, respectively. The trial design included a titration period in which the doses of study treatments (Tresiba(R) or insulin degludec UhypoglycaemiaSWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2) were gradually increased over a hypoglycaemia6 week period, followed by a hypoglycaemia6 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]
Tresiba(R) (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.[hypoglycaemiaSWITCH hypoglycaemia and 2],[hypoglycaemiahypoglycaemia] 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 UhypoglycaemiaSWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2.[hypoglycaemiahypoglycaemia],[hypoglycaemia2] Tresiba(R) received its first regulatory approval in September 2SWITCH hypoglycaemia and 2hypoglycaemia2 and has since been approved in more than 8SWITCH hypoglycaemia and 2 countries globally. It is now commercially available in more than 5SWITCH hypoglycaemia and 2 countries.
Novo Nordisk is a global healthcare company with more than 9SWITCH hypoglycaemia and 2 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 4hypoglycaemia,7SWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2 people in 77 countries and markets its products in more than hypoglycaemia65 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
Further information
Media:
Katrine Sperling +45 4442 67hypoglycaemia8 [email protected]
Asa Josefsson +45 3SWITCH hypoglycaemia and 279 77SWITCH hypoglycaemia and 28 [email protected] Investors:
Peter Hugreffe Ankersen +45 3SWITCH hypoglycaemia and 275 9SWITCH hypoglycaemia and 285 [email protected]
Hanna Ogren +45 3SWITCH hypoglycaemia and 279 85hypoglycaemia9 [email protected]
Anders Mikkelsen +45 3SWITCH hypoglycaemia and 279 446hypoglycaemia [email protected]
Christina Kjaer +45 3SWITCH hypoglycaemia and 279 3SWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 29 [email protected]
Kasper Veje (US) +hypoglycaemia 6SWITCH hypoglycaemia and 29 235 8567 [email protected] hypoglycaemia. Gumprecht J, Lane W, Chaykin LB, et al. Lower rate of hypoglycaemia with insulin degludec vs. insulin glargine UhypoglycaemiaSWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2 after adjusting for HbAhypoglycaemiac in SWITCH hypoglycaemia and 2. Poster presentation. International Diabetes Federation (IDF) Annual Congress 2SWITCH hypoglycaemia and 2hypoglycaemia7, Abu Dhabi, UAE. December 2SWITCH hypoglycaemia and 2hypoglycaemia7.
2. Lane W, Bailey TS, Gerety G, et al. Effect of insulin degludec vs insulin glargine UhypoglycaemiaSWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2 on hypoglycemia in patients with type hypoglycaemia diabetes: The SWITCH hypoglycaemia randomized clinical trial. JAMA. 2SWITCH hypoglycaemia and 2hypoglycaemia7;3hypoglycaemia8:33-44.
3. Wysham C, Bhargava A, Chaykin L, et al. Effect of insulin degludec vs insulin glargine UhypoglycaemiaSWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2 on hypoglycemia in patients with type 2 diabetes: The SWITCH 2 randomized clinical trial. JAMA. 2SWITCH hypoglycaemia and 2hypoglycaemia7;3hypoglycaemia8:45-56.
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. 2SWITCH hypoglycaemia and 2hypoglycaemia3;36:hypoglycaemia384-hypoglycaemia395.
5. International Hypoglycaemia Study Group. Diagnosis of hypoglycaemia. Available online at http://ihsgonline.com/understanding-hypoglycaemia/diagnosis. Last accessed November 2SWITCH hypoglycaemia and 2hypoglycaemia7.
6. Cryer P. Hypoglycemia, functional brain failure, and brain death. Journal of Clinical Investigation. 2SWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 27;hypoglycaemiahypoglycaemia7:868-87SWITCH hypoglycaemia and 2.
7. Pieber TR, Marso SP, McGuire DK, et al. DEVOTE 3: temporal relationships between severe hypoglycaemia, cardiovascular outcomes and mortality. Diabetologia. 2SWITCH hypoglycaemia and 2hypoglycaemia7.
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 hypoglycaemia and type 2 diabetes: the global HAT study. Diabetes Obes Metab. 2SWITCH hypoglycaemia and 2hypoglycaemia6;hypoglycaemia8:9SWITCH hypoglycaemia and 27-9hypoglycaemia5.
9. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of Hyperglycemia in Type 2 Diabetes, 2SWITCH hypoglycaemia and 2hypoglycaemia5: A Patient Centered Approach. Diabetes Care 2SWITCH hypoglycaemia and 2hypoglycaemia5;38:hypoglycaemia4SWITCH hypoglycaemia and 2-hypoglycaemia49.
hypoglycaemiaSWITCH hypoglycaemia and 2. Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet. 2SWITCH hypoglycaemia and 2hypoglycaemia4;53:787-8SWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2.
hypoglycaemiahypoglycaemia. EMA. Tresiba(R) Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/SWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 22498/WC5SWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2hypoglycaemia3894SWITCH hypoglycaemia and 2.pdf. Last accessed: November 2SWITCH hypoglycaemia and 2hypoglycaemia7.
hypoglycaemia2. Marso SP, McGuire DK, Zinman B, et al. Efficacy and safety of degludec versus glargine in type 2 diabetes. N Engl J Med. 2SWITCH hypoglycaemia and 2hypoglycaemia7;377:723-732.