According to results of a post-hoc analysis people with both type hypoglycaemia and type 2 diabetes in clinical practice may achieve improved glycaemic control (HbAhypoglycaemiac) with Tresiba(R) (insulin degludec) versus insulin glargine UhypoglycaemiaSWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2, without an increase in
hypoglycaemia (potentially dangerous low blood sugar).[hypoglycaemia] The results of this new analysis from the
SWITCH hypoglycaemia and 2 trials were presented today at the 54th Annual Meeting of the European Association for the Study of Diabetes (EASD 2SWITCH hypoglycaemia and 2hypoglycaemia8) in Berlin, Germany.
Lowering blood sugar to target levels is important to help prevent the complications of diabetes, but reductions can increase the risk of hypoglycaemia. In this post-hoc analysis, based on the reduction in hypoglycaemia risk with Tresiba(R) found in the maintenance period of the SWITCH trials, it is estimated that people with diabetes may achieve a mean HbAhypoglycaemiac reduction of SWITCH hypoglycaemia and 2.7SWITCH hypoglycaemia and 2% (type hypoglycaemia diabetes) and SWITCH hypoglycaemia and 2.96% (type 2 diabetes) with Tresiba(R) compared to insulin glargine UhypoglycaemiaSWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2 at similar rates of hypoglycaemia.[hypoglycaemia]
"Episodes of hypoglycaemia can be dangerous for people with diabetes and can often be a significant barrier to achieving glycaemic control," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "These findings add to already published evidence showing a reduced risk of hypoglycaemia with Tresiba(R), providing further confidence that this treatment may help people with diabetes achieve blood sugar control."
This post-hoc analysis is based on patient-level data from the SWITCH hypoglycaemia and 2 trials. The SWITCH trials demonstrated statistically 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]
This post-hoc analysis investigated the individual patient-level risk of hypoglycaemia by HbAhypoglycaemiac with Tresiba(R) and insulin glargine UhypoglycaemiaSWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2 to compare how glycaemic control differs at a similar rate of hypoglycaemia. For each trial participant at each visit their HbAhypoglycaemiac level was linked with the number of hypoglycaemic events (blood glucose-confirmed [<3.hypoglycaemia mmol/L] with symptoms or severe [third-party assistance]) since last visit. Reduction of hypoglycaemia risk with Tresiba(R) was calculated using the reduction in hypoglycaemia seen with Tresiba(R) compared to insulin glargine UhypoglycaemiaSWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2 in the SWITCH trials.[hypoglycaemia]
About SWITCH hypoglycaemia and 2
SWITCH hypoglycaemia and SWITCH 2 were two phase 3b, 64-week, double-blinded, 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 and at least one risk factor for hypoglycaemia, respectively. The trial design included a titration period in which the doses of study treatments (Tresiba(R) or insulin glargine 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 stable 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]
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 speech.[4,5] In severe cases it can lead to a seizure, coma or even death.[4,6]
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.[7,8] Tresiba led to an effective reduction in HbAhypoglycaemiac in clinical trials and showed a lower risk of hypoglycaemia in certain patient populations and studies compared to insulin glargine UhypoglycaemiaSWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2, in particular in type 2 diabetes.[2,3,8,9] It also provides for a lower day-to-day variability in glucose lowering effect versus insulin glargine UhypoglycaemiaSWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2.[8] 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 commercially available in more than 6hypoglycaemia countries.
Novo Nordisk is a global healthcare company with 95 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 43,hypoglycaemiaSWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2 people in 79 countries and markets its products in more than hypoglycaemia7SWITCH hypoglycaemia and 2 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
hypoglycaemia. Pedersen-Bjergard U, Philis-Tsimikas A, Lane W, et al. Relationship between HbAhypoglycaemiac and hypoglycaemia risk in individual patients comparing insulin degludec with insulin glargine UhypoglycaemiaSWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 2. Poster presented at the 54th Annual Meeting of the European Association for the Study of Diabetes (EASD), Berlin, Germany; hypoglycaemia-5 October 2SWITCH hypoglycaemia and 2hypoglycaemia8.
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: July 2SWITCH hypoglycaemia and 2hypoglycaemia8.
6. Cryer PE. Hypoglycemia, functional brain failure, and brain death. J Clin Invest. 2SWITCH hypoglycaemia and 2SWITCH hypoglycaemia and 27;hypoglycaemiahypoglycaemia7:868-87SWITCH hypoglycaemia and 2.
7. 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.
8. 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: July 2SWITCH hypoglycaemia and 2hypoglycaemia8.
9. 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.
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] Anders Mikkelsen
+45-3SWITCH hypoglycaemia and 279-446hypoglycaemia
[email protected] Valdemar Borum Svarrer
+45-3SWITCH hypoglycaemia and 279-SWITCH hypoglycaemia and 23SWITCH hypoglycaemia and 2hypoglycaemia
[email protected] Source: Novo Nordisk