ORLANDO, Florida, June 23, 2018 /PRNewswire/ --
Poster Presentation #1083-P
Ozempic® (semaglutide) 0.5 mg or 1.0 mg provided
greater weight reductions vs dulaglutide 0.75 mg or 1.5 mg,
respectively, in adults with type 2 diabetes, regardless of
baseline body mass index (BMI), with the greatest reductions
occurring in adults with a baseline BMI ≥25 kg/m2. While
the primary endpoint of SUSTAIN 7 was change in HbA1c,
this post-hoc exploratory analysis examined the secondary endpoint
of change in body weight by baseline BMI.1 The results
will be presented 24 June, 2018 at
the American Diabetes Association's 78th Scientific
Sessions (ADA) in Orlando, US.
Greater weight reductions were demonstrated across all BMI
subgroups (<25, 25-<30, 30-<35, ≥35 kg/m2) with
Ozempic® 0.5 mg vs dulaglutide 0.75 mg (range of weight
reduction across all subgroups: 3.6-5.5 kg vs 0.9-3.4
kg) and with Ozempic® 1.0 mg vs dulaglutide 1.5 mg
(range of weight reduction across all subgroups: 5.2-7.6 kg
vs 2.0-3.8 kg), from a mean baseline of 95.2 kg.1
Adults with a higher baseline BMI (≥25 kg/m2) taking
Ozempic® generally achieved greater weight reductions
than those with lower baseline BMI (<25
kg/m2).1
In addition, more people achieved weight reductions of ≥5% and
≥10% with Ozempic® vs dulaglutide in all BMI
subgroups.1
"Globally, up to ninety percent of people with type 2 diabetes
are overweight or have obesity.2 Therefore, it is
important to consider how to manage weight in this population,"
said Dr Adie Viljoen, SUSTAIN 7
chief investigator and consultant chemical pathologist, East and
North Hertfordshire NHS Trust, UK. "Based on the SUSTAIN clinical
trial programme, Ozempic® can help people living with
type 2 diabetes manage their HbA1C and has the potential
to help them lose some weight."
Across BMI subgroups, fewer people reported gastrointestinal
(GI) adverse events with the low dulaglutide dose (0.75 mg)
compared with the other three treatment groups (Ozempic®
0.5 and 1.0 mg and dulaglutide 1.5 mg).1 The most common
adverse events (≥5%) for both Ozempic® dosages were GI
adverse events.1
About
Ozempic®
Ozempic® (semaglutide) is a once-weekly analogue
of human glucagon-like peptide-1 (GLP-1) indicated as an adjunct to
diet and exercise to improve glycaemic control in adults with type
2 diabetes.3 Ozempic® was approved by the
U.S. Food and Drug Administration on 5
December, 2017, by Health Canada on 4
January, 2018, by the European Commission on 9 February, 2018 and on 23 March by the Japanese
Ministry of Health, Labour and Welfare.3-6
About the SUSTAIN clinical trial programme
The SUSTAIN global clinical development programme for
Ozempic® comprises eight phase 3a trials, encompassing
more than 8,000 adults with type 2 diabetes. The phase 3a programme
involves a broad range of people with type 2 diabetes, including
some with high cardiovascular risk profiles.
The primary analysis of the SUSTAIN 7 trial was published in
The Lancet Diabetes & Endocrinology earlier this year.
The primary outcome measure was change in HbA1c from
baseline after 40 weeks of treatment. Change in body weight from
baseline to week 40 was a predefined secondary
endpoint.7 In this post-hoc exploratory analysis, which
was conducted using Mixed Models for Repeated Measurements, the
interaction effect between treatment and subgroup was not
statistically significant (semaglutide 0.5 mg vs dulaglutide 0.75
mg: p= 0.9118; semaglutide 1.0 mg vs dulaglutide 1.5 mg: p=
0.8175).1
About Novo Nordisk
Novo Nordisk is a global healthcare company with 95 years of
innovation and leadership in diabetes care. This heritage has given
us experience and capabilities that also enable us to help people
defeat obesity, haemophilia, growth disorders and other
serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs approximately
42,700 people in 79 countries and markets its products in more than
170 countries. For more information, visit
novonordisk.com, Facebook,
Twitter, LinkedIn,
YouTube.
References:
1. Viljoen A, Blüher M, Chow F, et al. Semaglutide
reduces body weight vs dulaglutide across baseline BMI subgroups in
SUSTAIN 7. Abstract 1083-P. 78th Scientific Sessions of the
American Diabetes Association (ADA), Orlando, USA;
22-26 June 2018.
2. World Health Organization. Global Strategy on Diet,
Physical Activity and Health.
http://www.who.int/dietphysicalactivity/media/en/gsfs_obesity.pdf.
Updated 2003. Last accessed: May
2018.
3. Novo Nordisk. Ozempic® Prescribing
Information. Available at: http://www.novo-pi.com/ozempic.pdf. Last
accessed: May 2018.
4. Novo Nordisk. Ozempic® Canada Product
Monograph. Available at https://pdf.hres.ca/dpd_pm/00043163.PDF .
Last accesed: May 2018.
5. EMA. Ozempic® (semaglutide) SmPC. Available
at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR
Product_Information/human/004174/WC500244163.pdf. Last accessed:
May 2018.
6. Novo Nordisk. Ozempic® approved in
Japan for the treatment of type 2
diabetes. Available at:
https://www.novonordisk.com/content/Denmark/HQ/www-novonordisk-com/en_gb/home/media/news-details.2178681.html.
Last accessed: May 2018.
7. Pratley RE, Aroda VR, Lingvay I, et al.
Semaglutide once weekly versus dulaglutide once weekly in patients
with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase
3b trial. The Lancet Diabetes
& Endocrinology. 2018.
Further information
Media:
Katrine Sperling, +45-4442-6718, krsp@novonordisk.com
Åsa Josefsson,
+45-3079-7708, aajf@novonordisk.com
Michael Bachner (US), +1-609-664-7308,
mzyb@novonordisk.com
Investors:
Peter Hugreffe Ankersen, +45-3075-9085, phak@novonordisk.com
Anders Mikkelsen, +45-3079-4461, armk@novonordisk.com
Christina Kjær, +45-3079-3009, cnje@novonordisk.com