New long-acting basal insulin now available to help adults living with type 1 and type 2 diabetes manage blood sugar levels
MISSISSAUGA, ON, Oct. 3, 2017 /CNW/ - Today, Novo Nordisk announced the availability of Tresiba® (insulin degludec injection) in Canada, a new basal insulin for the once-daily treatment of adults with diabetes mellitus to improve glycemic control.1 Unlike other basal insulins in Canada, Tresiba® provides a duration of action beyond 42 hours with a flat and stable glucose-lowering effect.2 Tresiba® has been shown to have low risk of overall, nocturnal and severe hypoglycemia.3 It is the first insulin to be added to Canada's national Register of Innovative Drugs by Health Canada since the register was established in 2006.
Hypoglycemia, or low blood glucose/sugar, is the most common side effect associated with insulin therapy.4 It occurs when the level of glucose in the blood drops below normal. People managing their diabetes with insulin therapy are at risk of experiencing a hypoglycemic episode, which can cause confusion, numbness, seizures and even death.5
"Episodes of severe hypoglycemia are not only distressing for patients, and potentially dangerous, they are also associated with an increased risk of death," said Dr. Bernard Zinman of the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto. "For people living with diabetes that require insulin therapy, it is important to maintain low variability in blood sugar levels and reduce the risk of severe hypoglycemia."
Almost all people experiencing a hypoglycemic event, even if mild, will have a deterioration in cognitive function.6 Additionally, hypoglycemia is associated with depressive symptoms and heightened anxiety, lower health-related quality of life, and interpersonal conflict, including fear of dependency and loss of control.7
"Diabetes runs in my family, so my wife and I understand the challenges of effective management," says Ron Jones, who has been living with type 2 diabetes for 40 years. "Twice now, my blood sugar levels have dropped too low, so I was rushed to hospital – very frightening for both me and my wife, Pat. As someone with an increased risk of what I know now to be hypoglycemia, I feel like I am always waiting for another episode to hit, which can be scary at times. My wife and I want to make sure my diabetes is controlled as best as possible so we can focus on the joys in our later years."
About Tresiba®
Tresiba® (insulin degludec injection) is a once-daily, ultra-long-acting basal insulin approved in Canada on August 25, 2017 for the once-daily treatment of adults with diabetes mellitus to improve glycemic control. Tresiba® provides a duration of action beyond 42 hours,1 a low day-to-day variability and a low risk of overall, nocturnal and severe hypoglycemia.3 On occasion, when administration at the same time of day is not possible, Tresiba® allows for flexibility in day-to-day dosing time with a minimum of eight hours between injections.1 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, including Canada.
Hypoglycemia is the most common adverse reaction of all insulin preparations, including Tresiba®. The most common side effects found with Tresiba® are hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain.
About the Tresiba® Clinical Trial Program
Health Canada's approval of Tresiba® is based on an extensive body of evidence from a robust, multi-phased, multinational clinical trial program that includes the BEGIN trials.
In the BEGIN clinical trial program (phase 2 and phase 3a), insulin degludec achieved similar glycemic control to that seen with insulin glargine in patients with type 1 or 2 diabetes, but with a lower risk of nocturnal hypoglycemia. In addition, trials examining a flexible dosing regimen of insulin degludec in patients with type 1 or 2 diabetes show the potential for adjusting the injection time, without compromising glycemic control or safety.1
This global clinical program for Tresiba® was conducted in 40 countries with a total 35,580 patients. Specifically in Canada, 656 patients participated in the program.
About Hypoglycemia
When the amount of blood glucose has dropped below an individual's target range (less than four mmol/L), it is called low blood glucose or hypoglycemia.8
The incidence of severe hypoglycemia in the Canadian population with diabetes is estimated to be 1.9 and 2.6 episodes per patient per year in patients with type 1 and 2 diabetes, respectively, while the incidence of non-severe hypoglycemia is estimated to be 102 and 66 episodes per patient per year.9 Severe long term complications of hypoglycemia include micro and macrovascular complications.10
Nocturnal hypoglycemia may be the most common type of hypoglycemia in individuals with diabetes using insulin and is particularly worrisome as it often goes undetected and may lead to unconsciousness and death in severe cases.11
Research also shows that hypoglycemia causes more absenteeism from work, more impairment while at work (presenteeism) and decreased overall work productivity compared with patients who had never experienced the condition.12
About Novo Nordisk Canada
Novo Nordisk Canada Inc. is an affiliate of Novo Nordisk A/S, 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: hemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 41,400 employees in 77 countries, and markets its products in more than 165 countries.
References:
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Tresiba® (insulin degludec injection), Novo Nordisk Canada Inc., Product Monograph, August 25, 2017. |
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Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet. 2014; 53:787-800. |
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Marso SP, McGuire DK, Zinman B, et al. Efficacy and safety of degludec versus glargine in type 2 diabetes. N Eng J Med. 2017. DOI: 10.1056/NEJMoa1615692. |
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McNay E Coterio V. Mini Review: Impact of recurrent hypoglycemia on cognitive and brain function. Physiol Behav. 2010 June 1; 100(3): 234–238. |
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Inkster B. The Effects of Acute Hypoglycaemia on Cognitive Function in Type 1 Diabetes. British Journal of Diabetes and Vascular Disease. 2012;12(5):221-226 |
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Seaquest E, et al. Hypoglycemia and Diabetes: A Report of a Workgroup of the American Diabetes Association and The Endocrine Society. Diabetes Care. published online April 15, 2013. |
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Diabetes Canada. Low's & Highs: Blood Sugar Levels. Accessed August 2017. Available at http://www.diabetes.ca/diabetes-and-you/healthy-living-resources/blood-glucose-insulin/lows-highs-blood-sugar-levels. |
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Harris, S., Mamdani, M., Galbo-Jørgensen, C. B., Bøgelund, M., Gundgaard, J., & Groleau, D. (2014). The effect of hypoglycemia on health-related quality of life: Canadian results from a multinational time trade-off survey. Canadian journal of diabetes, 38(1), 45-52. |
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Shafiee G, Mohajeri-Tehrani M, Pajouhi M, Larijani B. J Diabetes Metab Disord. 2012; 11: 17. Published online 2012 October 1. doi: 10.1186/2251-6581-11-17 |
| 11 |
Brunton SA, Nocturnal hypoglycemia: answering the challenge with long-acting insulin analogs. MedGenMed. 2007 May 17;9(2):38. Accessed August 2017. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1994862/. |
| 12 |
Lopez JM, Annunziata K, et al. Impact of hypoglycemia on patients with type 2 diabetes mellitus and their quality of life, work productivity, and medication adherence. Patient Prefer Adherence. 2014 May 8;8:683-92 |
SOURCE Novo Nordisk Canada Inc.
Media: Katie Fraser, 416-486-7272, [email protected]; Kate Hanna, 905-629-6612, [email protected]
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