Saxenda(R) Provides Consistent Weight Loss and Improvements in Blood Glucose Control Across BMI Categories After Three Years of Treatment

PR65748

MUNICH, Sep. 14 / PRNewswire=KYODO JBN / --

This material is intended for global medical media only.

For journalistic assessment and preparation before publication.

Results from a post hoc analysis of the three-year part of the phase 3a SCALE

(Satiety and Clinical Adiposity - Liraglutide Evidence) Obesity and Prediabetes

trial show that people treated with Saxenda(R) (liraglutide 3 mg) experienced

consistent weight loss and improved blood glucose control across baseline body

mass index (BMI) categories over three years as compared to placebo treatment.

These data were presented today at the 52nd Annual Meeting of the European

Association for the Study of Diabetes (EASD) 2016.

In the trial, adults with prediabetes and obesity or who were overweight with

comorbidities were randomised to receive Saxenda(R) (n=1,505) or placebo

(n=749) for 160 weeks, both as an adjunct to a reduced-calorie diet and

increased physical activity.1

"Treating obesity and related comorbidities can be complex and challenging,"

said Professor Sten Madsbad, clinical professor at the University of Copenhagen

and a SCALE clinical trial investigator. "It is encouraging to now have

three-year data demonstrating that, regardless of starting BMI, people in the

trial experienced consistent weight loss and improvements in several measures

of glycaemic control."

As part of this analysis, measures of blood glucose control and the overall

safety profile across baseline BMI categories in people treated with Saxenda(R)

vs placebo were assessed. These baseline BMI categories were classified as;

overweight: BMI 27-29.9 kg/m2, obesity class 1: BMI 30-34.9 kg/m2, obesity

class 2: BMI 35-39.9 kg/m2 and obesity class 3 and over: BMI more than or equal

to 40 kg/m2. People treated with Saxenda(R) experienced consistent weight loss

across all BMI categories: 5.7%, BMI 27-29.9 kg/m2; 6.5%, BMI 30-34.9 kg/m2;

6.2%, BMI 35-39.9 kg/m2; 5.9%, BMI more than or equal to 40 kg/m2 compared to

1.8%, 1.7%, 1.8% and 2.1% in the same categories with placebo treatment. The

percentage of individuals who reverted to normal blood glucose levels at 160

weeks on Saxenda(R) was also similar at: 67%, 67%, 70% and 63%, respectively,

in each of the four BMI categories and significantly greater compared to 36%,

34%, 40% and 33%, respectively, with placebo (p＜0.05).1

In addition, consistent improvements were observed with Saxenda(R) treatment

across BMI categories for several measures of blood glucose control, including

HbA1c, fasting plasma glucose (FPG), fasting insulin, beta-cell function and

insulin resistance.1

There were similar incidences of total and serious adverse events as well as

gastrointestinal and hypoglycaemic events, across BMI categories.1 Saxenda(R)

was generally well-tolerated, with observed side effects in line with previous

trials.

About obesity      

Obesity is a disease2,3  that requires long-term management. It is associated

with many serious health consequences and decreased life-expectancy.4,5

Obesity-related comorbidities include type 2 diabetes, heart disease,

obstructive sleep apnoea (OSA) and certain types of cancer.4,6,7 It is a

complex and multi-factorial disease that is influenced by physiological,

psychological, environmental, socio-economic and genetic factors.8      

The global increase in the prevalence of obesity is a public health issue that

has severe cost implications to healthcare systems. In 2014, 13% of adults, or

approximately 600 million adults, were living with obesity.9

About Saxenda(R)   

Saxenda(R) (liraglutide 3 mg) is a once-daily glucagon-like peptide-1 (GLP-1)

analogue with 97% similarity to naturally occurring human GLP-1,10 a hormone

that is released in response to food intake.11 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.10 Saxenda(R) was evaluated in the SCALE (Satiety and

Clinical Adiposity - Liraglutide Evidence) phase 3a clinical trial programme.

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 more than or equal to 30 kg/m2 (obese), or more than or equal to

27 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.10

Guidance is given in the label that treatment with Saxenda(R) should be

discontinued if 5% weight loss has not been achieved by 16 weeks.10

About the SCALE clinical development programme   

Novo Nordisk's phase 3 development programme, called SCALE, investigates

liraglutide 3 mg for weight management. SCALE (Satiety and Clinical Adiposity -

Liraglutide Evidence) consists of four, placebo-controlled, multinational

trials called: SCALE Obesity and Prediabetes, SCALE Diabetes, SCALE Sleep

Apnoea and SCALE Maintenance.12-15 The trials include more than 5,000 people

who are overweight (BMI more than or equal to 27 kg/m2) with comorbidities such

as hypertension, dyslipidaemia, obstructive sleep apnoea (OSA) or type 2

diabetes or who have obesity (BMI more than or equal to 30 kg/m2), with or

without comorbidities. The studies all involved a reduced-calorie diet and

increased physical activity.10

Key results from all trials in the SCALE clinical development programme have

been published, with further data expected to be presented and published

throughout 2016.

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 42,300 people in

75 countries and markets its products in more than 180 countries. For more

information, visit novonordisk.com , Facebook, Twitter, LinkedIn, YouTube  

Further information

Media:

Katrine Sperling

+45-4442-6718

krsp@novonordisk.com

Asa Josefsson

+45-3079-7708

aajf@novonordisk.com

Investors:

Peter Hugreffe Ankersen

+45-3075-9085

phak@novonordisk.com

Melanie Raouzeos

+45-3075-3479

mrz@novonordisk.com

Hanna Ogren

+45-3075-8519

haoe@novonordisk.com

Kasper Veje (US)

+1-609-235-8567

kpvj@novonordisk.com

_______________________

References  

1. Madsbad S, Lieberman G, Skjoth TV, et al. Comparable efficacy and safety of

liraglutide 3.0 mg for weight management across baseline BMI subgroups: Results

from the SCALE Obesity and Prediabetes trial. EASD. 2016

2. American Medical Association. A.M.A Adopts New Policies on Second Day of

Voting at Annual Meeting. Obesity as a Disease. Available at:

http://www.ama-assn.org/ama/pub/news/news/2013/2013-06-18-new-ama-policies-annual-meeting.page.

Last accessed: July 2016.

3. WHO. Obesity: Preventing and managing the global epidemic. Available at:

http://www.who.int/iris/handle/10665/42330 Last accessed: August 2016.

4. Guh DP, Zhang W, Bansback N, et al. The incidence of co-morbidities related

to obesity and overweight: a systematic review and meta-analysis. BMC Public

Health. 2009; 25:88.

5. Peeters A, Barendregt JJ, Willekens F, et al. Obesity in adulthood and its

consequences for life expectancy: a life-table analysis. Annals of Internal

Medicine. 2003; 138:24-32.

6. Gami AS, Caples SM, Somers VK. Obesity and obstructive sleep apnea.

Endocrinology and Metabolism Clinics of North America. 2003; 32:869-894.

7. Whitlock G, Lewington S, Sherliker P, et al. Body-mass index and

cause-specific mortality in 900 000 adults: collaborative analyses of 57

prospective studies. Lancet. 2009; 373:1083-1096.

8. Wright SM, Aronne LJ. Causes of obesity. Abdominal Imaging. 2012; 37:730-732.

9. WHO. Obesity and Overweight Factsheet no. 311. Available at:

http://www.who.int/mediacentre/factsheets/fs311/en/. Last accessed: August 2016.

10. EMA. Saxenda(R) (liraglutide 3 mg) summary of product characteristics.

Available at:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003780/WC500185786.pdf.

Last accessed: August 2016.

11. Knudsen LB, Nielsen PF, Huusfeldt PO, et al. Potent derivatives of

glucagon-like peptide-1 with pharmacokinetic properties suitable for once daily

administration. Journal of Medicinal Chemistry. 2000; 43:1664-1669.

12. Blackman A, Foster G, Zammit G, et al. Effect of liraglutide 3.0mg

in individuals with obesity and moderate or severe obstructive sleep apnea: the

SCALE Sleep Apnea randomized clinical trial. International Journal of Obesity.

2016; doi: 10.1038/ijo.2016.52. [Epub ahead of print]

13. Davies MJ, Bergenstal R, Bode B, et al. Efficacy of liraglutide for weight

loss among patients with type 2 diabetes: The SCALE diabetes randomized

clinical trial. Journal of the American Medical Association. 2015; 314:687-699.

14. Pi-Sunyer X, Astrup A, Fujioka K, et al. A randomized controlled trial of

3.0 mg of liraglutide in weight management. New England Journal of Medicine.

2015; 373:11-22.

15. Wadden TA, Hollander P, Klein S, et al. Weight maintenance and additional

weight loss with liraglutide after low-calorie-diet-induced weight loss: The

SCALE Maintenance randomized study. International Journal of Obesity. 2013;

37:1443-1451.

SOURCE: Novo Nordisk