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Today, new data from a post-hoc analysis of the phase 3a SCALE(TM) clinical development programme were presented at the 51st European Association for the Study of Diabetes (EASD) Annual Meeting. The data demonstrated that adults in the SCALE(TM) Obesity and Prediabetes and SCALE(TM) Diabetes trials who lost at least 5% of their body weight after completing 16 weeks of Saxenda(R) (liraglutide 3 mg) treatment (defined as 'early responders') had greater weight loss after completing 56 weeks, compared with people losing less than 5% body weight with Saxenda(R) after completing 16 weeks ('early non-responders'). All treatment groups included a reduced-calorie diet and increased physical activity.
"These data demonstrate the importance of identifying those adults who respond early to Saxenda(R)," said Professor Matthias Blüher, head of the obesity outpatient clinic at the University of Leipzig, Germany, and SCALE(TM) trial investigator. "Not only are these Saxenda(R) early responders more likely to achieve greater weight loss over time, they are also more likely to experience greater improvements in cardiometabolic risk factors."
After completing 16 weeks of the SCALE(TM) Obesity and Prediabetes trial, 67.5% of adults with obesity or who were overweight with weight-related comorbidities (excluding type 2 diabetes), were early responders to Saxenda(R) (n=2487) and experienced an average weight loss of 11.5% after completing 56 weeks of treatment, compared with a weight loss of 3.8% for early non-responders. The proportion of early responders losing greater than or equal to5%, >10% and >15% of their bodyweight after completing 56 weeks was 88.2%, 54.8% and 24.2% respectively (36.9%, 8.3% and 1.8% respectively for early non-responders).
After completing 16 weeks of the SCALE(TM) Diabetes trial, 50.4% of adults with obesity or who were overweight and had type 2 diabetes, were early responders to Saxenda (R) (n=423), with a mean weight loss of 9.3% after completing 56 weeks of treatment compared with a weight loss of 3.6% for early non-responders. The proportion of early responders experiencing greater than or equal to5%, >10% and >15% weight loss after completing 56 weeks was 80.1%, 44.6% and 11.6% respectively (33.3%, 5.8% and 1.3% respectively for early non-responders).
Across both trials, early responders demonstrated greater improvements in cardiometabolic risk factors, including blood pressure, cholesterol and triglycerides, compared to early non-responders.
The overall safety profile was generally comparable between early responders and early non-responders. In the SCALE(TM) Obesity and Prediabetes trial serious adverse events occurred in 6.4% vs 5.3% respectively, and in the SCALE(TM) Diabetes trial 7.6% vs 9.9%, respectively. Hepatobiliary events (related to the liver and/or the gallbladder) were higher in early responders compared with early non-responders in the SCALE(TM) Obesity and Prediabetes trial (3.5% vs 2.1% respectively). In people with obesity or who were overweight and with type 2 diabetes, rates of severe hypoglycaemia were low in both early responders and early non-responders (1.1% vs. 0.6% respectively) and all cases were in people who were taking prescribed sulfonylureas.
Obesity is a disease that requires long-term management. It is associated with many serious health consequences and decreased life-expectancy., Obesity-related comorbidities include type 2 diabetes, heart disease, obstructive sleep apnoea (OSA) and certain types of cancer.,, It is a complex and multi-factorial disease that is influenced by genetic, physiological, environmental and psychological factors.
The global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. In the EU, obesity affects approximately 10-30% of adults.
Saxenda(R) (liraglutide 3 mg) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake. Like human GLP-1, Saxenda(R) regulates appetite by increasing feelings of fullness and satiety, while lowering feelings of hunger and prospective food consumption, thereby leading to reduced food intake. As with other GLP-1 receptor agonists, Saxenda(R) stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner. These effects can lead to a reduction of fasting and post-prandial blood glucose. Saxenda(R) was evaluated in the SCALE(TM) (Satiety and Clinical Adiposity - Liraglutide Evidence in Nondiabetic and Diabetic people) phase 3 clinical trial programme.
Saxenda(R) was granted European marketing authorisation on 23 March 2015 by the European Commission (EC). In the EU, Saxenda(R) is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial BMI of greater than or equal to30 kg/m2 (obese), or greater than or equal to27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.
Saxenda(R) was approved by the FDA on 23 December 2014 and Health Canada on 26 February 2015. Please refer to local label for further information.
Guidance is given in all labels that treatment with Saxenda(R) should be discontinued if a specific threshold of weight loss has not been achieved after a certain period of time.
About the SCALE(TM) clinical development programme
Novo Nordisk's phase 3 development programme, called SCALE(TM), investigates liraglutide 3 mg for weight management. SCALE(TM) (Satiety and Clinical Adiposity - Liraglutide Evidence in Non-diabetic and Diabetic people) consists of four, placebo-controlled, multinational trials called: SCALE(TM) Obesity and Prediabetes, SCALE (TM) Diabetes, SCALE(TM) Sleep Apnoea and SCALE(TM) Maintenance. The trials include more than 5,000 people who are overweight (BMI greater than or equal to27 kg/m2) with comorbidities such as hypertension, dyslipidaemia, obstructive sleep apnoea (OSA) or type 2 diabetes, or who have obesity (BMI greater than or equal to30 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(TM) clinical development programme have been published, with further data expected to be presented and published in 2015.
About Novo Nordisk
Novo Nordisk is 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: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,700 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com [http://novonordisk.com], Facebook [http://www.facebook.com/novonordisk], Twitter [http://www.twitter.com/novonordisk], LinkedIn [http://www.linkedin.com/company/novo-nordisk], YouTube [http://www.Youtube.com/novonordisk]
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Peter Hugreffe Ankersen
Frank Daniel Mersebach (US)