VANCOUVER, Dec. 1, 2015 /CNW/ - Today, pooled data from five clinical trials of Saxenda® (liraglutide), the first once-daily human glucagon-like peptide-1 (GLP-1) analogue for chronic weight management in combination with diet and exercise approved by Health Canada, was presented at the International Diabetes Federation (IDF) World Diabetes Congress in Vancouver. This post hoc analysis showed that Saxenda® treatment, in combination with a reduced-calorie diet and increased physical activity, provided weight loss that was similar across racial subgroups.3
"It should come as no surprise that obesity rates and body mass index (BMI) vary among different ethnic and racial groups, and oftentimes, a weight loss method that works well for one ethnicity does not necessarily show similar results for another," said Dr. Michael Lyon, Medical Director, Medical Weight Management Centre, Vancouver. "The data being presented in Vancouver at IDF is encouraging, demonstrating consistent and similar weight loss results among all groups studied in the Saxenda® clinical trial program, independent of ethnic background."
Rising diabetes and obesity rates in racial subgroups is a growing concern in Canada.1 "Small increases in weight can have a major effect on the risk of developing related health conditions," said Dr. Lyon.
The analysis included data from one 52-week Phase 2 trial and the four Phase 3 SCALE™ clinical development program trials (three 56 weeks long, and one 32 weeks long) that compared efficacy and safety of Saxenda® with placebo (diet and exercise alone), in four different racial subgroups (White, Black, Asian and other). These randomized double-blinded trials included adults with obesity, or who were overweight with comorbidities, with (n=844) or without (n=4969) type 2 diabetes.3
Recognized as a chronic disease by the Canadian Medical Association, obesity is associated with serious comorbidities including hypertension, type 2 diabetes mellitus, dyslipidemia, certain types of cancer and a decreased life expectancy.4 The risk of morbidity and mortality increases with the severity of obesity. It is a complex and multi-factorial disease that is influenced by genetic, physiological, environmental and psychological factors.5
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. In Canada, approximately 25 per cent of adults, equivalent to approximately 6.5 million people, live with obesity.6
Saxenda® (liraglutide) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97 per cent similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake. Saxenda® is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes, or dyslipidemia) and who have failed a previous weight management intervention. Like human GLP-1, Saxenda® regulates appetite and lowers body weight through decreased food intake. As with other GLP-1 receptor agonists, liraglutide stimulates insulin secretion and reduces glucagon secretion in a glucose-dependent manner. These effects can lead to a reduction of blood glucose. Saxenda® was evaluated in the SCALE™ (Satiety and Clinical Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic people) phase 3 clinical trial program, which involved more than 5,000 people with obesity (BMI ≥30 kg/m2) or who were overweight (BMI ≥27 kg/m2) with at least one weight-related comorbidity.7
About the SCALE™ clinical development program
Novo Nordisk's phase 3 development program, called SCALE™, investigates liraglutide 3 mg for weight management. SCALE™ (Satiety and Clinical Adiposity – Liraglutide Evidence in Non-diabetic and Diabetic people) consists of four, placebo-controlled, multinational trials called: SCALE™ Obesity and Prediabetes, SCALE™ Diabetes, SCALE™ Sleep Apnoea and SCALE™ Maintenance. The trials include more than 5,000 people who are overweight (BMI ≥27 kg/m2) with comorbidities such as hypertension, dyslipidaemia, obstructive sleep apnoea (OSA), or type 2 diabetes, or who have obesity (BMI ≥30 kg/m2), with or without comorbidities. The studies all involved a reduced-calorie diet and increased physical activity.
Key results from all trials in the SCALE™ clinical development program have been published, with further data expected to be presented and published in 2016.
About Novo Nordisk
Novo Nordisk Canada 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 40,300 employees in 75 countries, and markets its products in more than 180 countries.
Novo Nordisk's company history has deep Canadian roots, with company founders Marie and August Krogh traveling to Toronto in 1922 to meet with Banting, Best, Collip and MacLeod to discuss the insulin preparation. Novo Nordisk would become the first company in Europe to produce insulin in 1923.
Novo Nordisk Canada employs approximately 280 people at its head office in Mississauga and across Canada. The company is listed as one of Canada's Top 100 Employers for 2016 and has also been awarded the distinction of being a Top GTA Employer since 2008. For more information, visit www.novonordisk.ca or follow us on Twitter @NovoNordiskCA.
1 Chiu M, Maclagan L, Tu J, et al. Temporal trends in cardiovascular disease risk factors among white, South Asian, Chinese and black groups in Ontario, Canada, 2001 to 2012: a population-based study. BJM Open 2015;5 e007232. Available at: http://bmjopen.bmj.com/content/5/8/e007232.full. Accessed November 2015.
2 Caprio S, Daniels S, Drewnowski A, et al. Influence of race, ethnicity, and culture on childhood obesity: implications for prevention and treatment. Diabetes Care Journal, November 2008, vol. 31 no. 11, 2211-2221. Available at: http://care.diabetesjournals.org/content/31/11/2211.full. Accessed November 2015.
3 Ard JC, A; Lewis, C; Lofton, H; Jacobsen, P; Stevenin, B; Pi-Sunyer, X. The efficiacy and safety of liraglutide 3.0 mg for weight management are similar across races International Diabetes Federation. 2015 Available at: http://aace.multilearning.com/aace/2015/eposter/97745/jamy.ard.efficacy.and.safety.of.liraglutide.3.0.mg.for.weight.management.are.html?f=p6m3e813o10393. Accessed November 2015.
4 CMA news release. "CMA recognizes obesity as a disease". October 9, 2015. Available at: https://www.cma.ca/En/Pages/cma-recognizes-obesity-as-a-disease.aspx. Accessed November 2015.
5 Multimorbidity in a prospective cohort: Prevalence and associations with weight loss and health status in severely obese patients. Obesity (Silver Spring). 2015 Mar;23(3):707-12. doi: 10.1002/oby.21008. Epub 2015 Feb 13. Accessed November 2015.
6 Public Health Agency of Canada & Canadian Institute for Health Information. Obesity in Canada, 20 June 2011. Accessed November 2015.
7 Health Canada. Saxenda® (liraglutide), Novo Nordisk Canada Inc., Product Monograph, 26 February 2015.
SOURCE Novo Nordisk Canada Inc.
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