Searching for your content…
Phone
877-269-7890 from 8 AM – 10 PM ET
Contact Cision
877-269-7890
from 8 AM – 10 PM ET
News provided by
Nov 03, 2022, 07:01 ET
Share this article
Tresiba®, Canada’s leading basal insulin, now approved for use during pregnancy
MISSISSAUGA, ON, Nov. 3, 2022 /CNW/ – Today, Novo Nordisk Canada announced that Health Canada has approved an update to the label for Tresiba® (insulin degludec injection) for use in pregnant women with diabetes. Tresiba® is a once-daily, long-acting basal insulin treatment that allows for those with diabetes to have improved glycemic control and can now be considered during pregnancy if the benefit justifies possible risks and if clinically needed.1
In Canada, there are more than 5.7 million people living with diabetes.2 The most common diagnosis is type 2 diabetes, accounting for approximately 90 per cent of diabetes cases in Canada, followed by type 1 diabetes.2 The key to a healthy pregnancy for a woman with diabetes is keeping blood glucose levels in the target range – both before she is pregnant and during her pregnancy.3
“Women living with diabetes face multiple challenges – especially during pregnancy. Rigorous glucose control prior to conception and throughout pregnancy is vital to the health of mother and developing baby,” says Dr. Joanne Liutkus, MD, FRCP(C), Internal and Obstetric Medicine, Department of Medicine, McMaster University. “The availability of innovative insulin therapy, such as Tresiba, for use during pregnancy make it possible for us to safely and effectively achieve glucose targets.”
In diabetes pregnancies, studies show higher rates of complications compared to the general population, including perinatal mortality, congenital malformations, hypertension, preterm delivery, large-for-gestational-age (LGA) infants, caesarean delivery and other neonatal morbidities.4,5,6,7
The update is based on the results from the EXPECT Pregnancy Trial which investigated Tresiba® versus Levemir® (insulin detemir), both in combination with NovoRapid® (insulin aspart).1 Results from the EXPECT study confirmed that the efficacy of Tresiba® was non-inferior to Levemir® with respect to A1C, in pregnant women with type 1 diabetes.1 In addition, no clinically relevant differences in glycemic control during pregnancy and similar pregnancy outcomes between Tresiba® and Levemir® were reported, when used in combination with NovoRapid®.1 Levemir®, in combination with NovoRapid®, have been widely used in clinical practice and can be considered during pregnancy, if benefit justifies possible risks.8
The EXPECT study is an open-label, randomized trial of 225 women aged ≥18 years with type 1 diabetes and who were previously treated with insulin and were at 8-13 weeks’ gestation or planned to become pregnant within 52 weeks. The study included women living in Argentina, Australia, Austria, Brazil, Canada, Croatia, Denmark, Greece, Ireland, Israel, Italy, Russia, Serbia and the United Kingdom. The study participants were randomized to be treated with Tresiba® (insulin degludec injection) once daily or Levemir® (insulin detemir) 1-2 times daily, both with NovoRapid® (insulin aspart) 2-4 times daily. The primary analysis aimed to demonstrate the non-inferiority (margin of 0.4%) of degludec to detemir with respect to the last planned glycated hemoglobin (HbA1c) measurement prior to delivery (>16 weeks’ gestation) using ANCOVA. Secondary endpoints were maternal efficacy and safety outcomes, as well as pregnancy outcomes.
Tresiba® (insulin degludec injection) is a once-daily, 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.1 Tresiba® provides a duration of action beyond 42 hours with a flat and stable glucose-lowering effect.8,9 Tresiba® is also indicated for the treatment of pediatric patients 2 years old or older with Type 1 diabetes mellitus.1 It has been shown to provide a lower risk of overall, nocturnal and severe hypoglycemia, and low variability in blood sugar levels versus insulin glargine U100.1,10 Tresiba® received its first international regulatory approval in September 2012 and has since been approved in more than 116 countries globally. It is now commercially available in over 60 countries.
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.9 Consult the Tresiba® Product Monograph for more information.
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 50,800 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.ca and Twitter.
1 Novo Nordisk Canada Inc. TRESIBA® Product Monograph. October 27, 2022.
2 Diabetes Canada. https://www.diabetes.ca/media-room/press-releases/diabetes-rates-continue-to-climb-in-canada. Accessed October 19, 2022.
3 Diabetes Canada. Clinical Practice Guidelines. https://www.diabetes.ca/health-care-providers/clinical-practice-guidelines/chapter-36#panel-tab_FullText Accessed October 27, 2022.
4 Feig DS, Hwee J, Shah BR, et al. Trends in incidence of diabetes in pregnancy and serious perinatal outcomes: A large, population-based study in Ontario, Canada, 1996–2010. Diabetes Care 2014;37:1590–6.
5 CEMACH. Pregnancy in women with type 1 and type 2 diabetes in 2002-03, England, Wales and Northern Ireland. London, UK: Confidential Enquiry into Maternal and Child Health (CEMACH), 2005 http://www.bathdiabetes.org/resources/254.pdf.
6 Feig DS, Razzaq A, Sykora K, et al. Trends in deliveries, prenatal care, and obstetrical complications in women with pregestational diabetes: A population-based study in Ontario, Canada, 1996–2001. Diabetes Care 2006;29:232–5.
7 Macintosh MC, Fleming KM, Bailey JA, et al. Perinatal mortality and congenital anomalies in babies of women with type 1 or type 2 diabetes in England, Wales, and Northern Ireland: Population based study. BMJ 2006;333:177.
8 Novo Nordisk Canada Inc. Levemir® Product Monograph. August 12, 2021. https://www.novonordisk.ca/content/dam/nncorp/ca/en/products/levemir-product-monograph.pdf Accessed October 13, 2022.
9 Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet. 2014; 53:787-800.
10 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.
SOURCE Novo Nordisk Canada Inc.
For further information: Media: Jaclyn Crawford, 647-201-6817, [email protected]
Also from this source
Health Canada approves REBINYN® (Coagulation Factor IX (Recombinant), pegylated) for the treatment of routine prophylaxis to prevent or reduce frequency of bleeding episodes in children with hemophilia B
Camp Huronda welcomes back campers for a long-awaited reopening and unveils the new Insul-Inn
877-269-7890
from 8 AM – 10 PM ET