MUNICH, September 14, 2016 /PRNewswire/ --
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 greater than or equal to40 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 greater than or equal to40 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
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.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 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.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 [http://www.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 ]
